Web-Based Telepresence Exercise Program for Community-Dwelling Elderly Women With a High Risk of Falling: Randomized Controlled Trial

Background While physical exercise is known to help prevent falls in the elderly, bad weather and long distance between the home and place of exercise represent substantial deterrents for the elderly to join or continue attending exercise programs outside their residence. Conventional modalities for home exercise can be helpful but do not offer direct and prompt feedback to the participant, which minimizes the benefit. Objective We aimed to develop an elderly-friendly telepresence exercise platform and to evaluate the effects of a 12-week telepresence exercise program on fall-related risk factors in community-dwelling elderly women with a high risk of falling. Methods In total, 34 women aged 68-91 years with Fall Risk Assessment scores >14 and no medical contraindication to physical training-based therapy were recruited in person from a senior citizen center. The telepresence exercise platform included a 15-inch tablet computer, custom-made peer-to-peer video conferencing server system, and broadband Internet connectivity. The Web-based program included supervised resistance exercises performed using elastic resistance bands and balance exercise for 20-40 minutes a day, three times a week, for 12 weeks. During the telepresence exercise session, each participant in the intervention group was supervised remotely by a specialized instructor who provided feedback in real time. The women in the control group maintained their lifestyle without any intervention. Fall-related physical factors (body composition and physical function parameters) and psychological factors (Korean Falls Efficacy Scale score, Fear of Falling Questionnaire score) before and after the 12-week interventional period were examined in person by an exercise specialist blinded to the group allocation scheme. Results Of the 30 women enrolled, 23 completed the study. Compared to women in the control group (n=13), those in the intervention group (n=10) showed significant improvements on the scores for the chair stand test (95% confidence interval -10.45 to -5.94, P<.001), Berg Balance Scale (95% confidence interval -2.31 to -0.28, P=.02), and Fear of Falling Questionnaire (95% confidence interval 0.69-3.5, P=.01). Conclusions The telepresence exercise program had positive effects on fall-related risk factors in community-dwelling elderly women with a high risk of falling. Elderly-friendly telepresence technology for home-based exercises can serve as an effective intervention to improve fall-related physical and psychological factors. Trial Registration Clinical Research Information Service KCT0002710; https://cris.nih.go.kr/cris/en/search/ search_result_st01.jsp?seq=11246 (Archived by WebCite at http://www.webcitation.org/6zdSUEsmb)

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The title specifies the mode of delivery. "Web-based Telepresence Exercise Program for Elderly Women with a High Risk of Falling: A Randomized Controlled Trial" 1a-ii) Non-web-based components or important cointerventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No non-web-based components or important co-interventions were used in this study. Therefore, no such aspects are mentioned in the title. subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The title specifies the target population. "Elderly Women with a High Risk of Falling" 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The Abstract includes an overview of the intervention "The telepresence exercise platform included a 15-inch tablet computer, custom-made peer-to-peer video conferencing server system, and broadband Internet connectivity. The web-based program included supervised resistance exercises performed using elastic resistance bands and balance exercise for 20-40 minutes a day, three times a week, for 12 weeks. During the telepresence exercise session, each participant was supervised remotely by a specialized instructor who provided feedback in real time." The study design is also mentioned in the Abstract (randomization into the intervention and control groups, outcome measures, timing of evaluation, and blinding of evaluators). Detailed information regarding the implementation (e.g., server components and APIs) is not 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The telepresence intervention involved one-on-one exercise sessions with a remotely located specialized instructor: "During the telepresence exercise session, each participant in the intervention group was supervised remotely by a specialized instructor who provided feedback in real time." Recruitment and evaluation were both performed in person: "A total of 34 women aged 68-91 years, with Fall Risk Assessment scores >14 and no medical contraindication to physical training-based therapy were recruited in person from a senior citizen center." "Fall-related physical factors (body composition and physical function parameters) and psychological factors (Korean Falls Efficacy Scale score, Fear of Falling Questionnaire score) before and after the 12-week interventional period were examined in person by an exercise specialist blinded to the group allocation scheme." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Recruitment and evaluation were both performed in person: "A total of 34 women, aged 68-91 years, with Fall Risk Assessment scores >14 and no medical contraindication to physical training-based therapy were recruited in person from a senior citizen center." "Fall-related physical factors (body composition and physical function parameters) and psychological factors (Korean Falls Efficacy Scale score, Fear of Falling Questionnaire score) before and after the 12-week interventional period were examined in person by an exercise specialist blinded to the group allocation scheme." The intervention itself involved one-on-one exercise sessions with a remotely located specialized instructor: "During the telepresence exercise session, each participant in the intervention group was supervised remotely by a specialized instructor who provided feedback in real time." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The Results section of the Abstract mentions how many subjects were enrolled, how many completed the trial, and how many in each group were included in the analysis. "Of the 30 women enrolled, 23 completed the study. Compared to women in the control group (n=13), those in the intervention group (n=10) showed significant improvements in the scores for the…" The main issue addressed is the lack of adequate exercise programs and platforms for elderly individuals with a high risk of falling. These aspects are explained in the Introduction. "… the elderly are more affected by weather conditions, as reflected by their lower attendance rate [9]. Moreover, because traveling is typically more difficult for the elderly, the distance between the residence and the place of exercise represents another deterrent for the elderly to join or continue attending exercise programs outside of their home." "However, since these types of unsupervised exercise do not offer direct and prompt feedback to the participant, it is difficult for the elderly to benefit fully from such exercise programs, and the risk of injury is higher." "While many technologies for remote supervision are available, such approaches are not readily adopted by elderly people, who generally have a relatively poorer understanding of computers and similar technologies [15]." The solution proposed is structured as a single intervention aiming to reduce the risk of falls by improving physical and psychological risk 2a-ii) Scientific background, rationale: What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator.

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Interactive technologies and web-based solutions for at-home exercise (e.g., exergames, tele-exercise using Skype) exist and are widely available but typically have a very low uptake rate among the elderly, especially if the risk of falls is high. These aspects are mentioned in the Introduction. "Exergames that employ a 3-D depth camera have been introduced over the past few years, and have gained substantial attention in the field of physical exercise-based therapy because they can provide realtime feedback to participants using natural user interface technologies [12]. However, most exergames emphasize the fun elements because they target younger age groups; therefore, exergames are of limited use in the elderly population [13]. In addition, in a previous study involving tele-exercise using Skype [14], the user interface and experience were found to not be elderly-friendly. While many technologies for remote supervision are available, such approaches are not readily adopted by elderly people, who generally have a relatively poorer understanding of computers and similar technologies [15]." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The aims of the study are mentioned in the last paragraph of the Introduction. "In this study, we propose a home-based telepresence exercising program as a new intervention method to prevent falls among highrisk, elderly individuals. Specifically, we developed a novel telepresence exercise platform using information and communication technology to provide supervised physical training sessions to elderly participants at home, with real-time feedback from a remotely located instructor trained to assess the physical, cognitive, and emotional response of the elderly participant. Finally, we investigated the effect of the telepresence training program on fall-related physical and Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The study design is mentioned at the very beginning of the Methods. "This study was designed as a double-blind, parallel-group, randomized controlled trial study." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   All conditions were pre-defined and fully described in the Methods. There were no changes to the methods after trial commencement. Such details are included in the Participants and Procedures sections 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes and there was no downtime during the intervention period. These aspects are mentioned at the end of the Telepresence Platform section in the Methods. "For the developed telepresence exercise platform, adequate user acceptance testing was conducted by focus groups until March 1st, 2015. Throughout the intervention period, no bug fixes or content changes were made to the platform. There was no downtime (planned or unplanned) during the intervention period." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   These details are fully described in the Participants section of the Methods. "Thirty-four community-dwelling elderly women aged above 65 years and having a Fall Risk Assessment Scale [19] score of 14 points or higher were recruited from the Senior Citizen Centre in Gangseo-gu, Seoul, South Korea, between February 10th, 2015 and March 8th, 2015. Recruitment was performed in person by the research coordinator. Four women were excluded based on the following criteria: history of regular exercise in the 6 months leading up to the 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Computer or internet literacy was not required as an eligibility criterion. Prior to initiation of the study, all necessary materials were provided to the participants free of charge and with complete instructions. These aspects are clarified in the Participants and Procedures sections of the Methods, respectively. "Computer or internet literacy was not required as an eligibility criterion." subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Recruitment, instruction, and evaluation (pre-and post-intervention) were performed in person: "Fall-related risk factors were assessed in person one week prior to initiating the intervention. At that time, each participant and the exercise instructor were provided with a tablet PC (personal computer), folding chairs, exercise mats, resistance bands, and instructions describing the simple steps necessary to turn on and operate the tablet, facilitating participation in the web-based telepresence exercise program…. A post-test assessment was performed during the last week of the 12-week program." All participants received guidance once per month, and control subjects were followed-up by telephone: "During the intervention period, nutrition guidance and exercise education were provided to all participants once every 4 weeks…. CG levels of physical activity and nutrition intake were checked every 2 weeks by phone and during the education sessions." The intervention itself involved one-on-one exercise sessions with a remotely located specialized instructor, and the full details are subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The participants were recruited in person. All persons who fulfilled the eligibility criteria, as described in the Methods, were briefed regarding the study goals, methods, freedom to withdraw. We have added the informed consent documentation as supplementary material. All materials and instructions of use were provided one week before the study. Educational activities were organized throughout the study duration. These details are mentioned in the Participants and Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All data were collected and stored at the Biomedical Research Institute of Seoul National University Hospital in Seoul, Korea." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Outcomes were not assessed through online questionnaires. "All measurements were performed by an exercise specialist blinded to the group allocation scheme." 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The institutional affiliation (i.e., Seoul National University) was displayed on the first page of the website (which was in Korean) used to access the telepresence exercise platform. However, participants were not recruited online, but from a senior citizen center; recruitment was performed in person by the study coordinator. Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The authors of the manuscript are the owners and developers of the telepresence platform, a fact implied at various points in the manuscript. "We developed the telepresence exercise platform including an 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Complete details regarding the development and implementation of the platform (components, development and implementation framework, website access, testing, and usage) are given in the Telepresence Platform section of the Methods.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes and there was no downtime during the intervention period. These aspects are mentioned at the end of the Telepresence Platform section in the Methods.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Adequate testing of the telepresence platform (including user acceptance testing by focus groups) was performed prior to initiation of the study. There were no changes and there was no downtime during the intervention period. These aspects are mentioned at the end of the Telepresence Platform section in the Methods. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Screenshots of the instructor and participant side during the telepresence exercise session are provided in Figure 3. The framework of the platform is provided in Figure 2

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Information on how the app was accessed is provided in the Methods: "The website (http://smarth.iptime.org) was accessed via the web browser (Google Chrome v.26.0) installed on the tablet PC …" Screenshots of the instructor and participant side during the telepresence exercise session are provided in Figure 3.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Access was provided via a dedicated website. All necessary materials (dedicated tablet with remote-access software; broadband Internet; training materials such as mats) and usage instructions were provided to the participants one week before initiation of the trial, free of charge. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   A dedicated telepresence platform and website were developed for this study. Their design and functionality was tailored to the target group (i.e., community-dwelling, elderly individuals with a high risk of falls). A description of the platform and website is provided in the Telepresence Platform section of the Methods, and an overview of the framework is shown in Figure 2.
The telepresence exercise intervention was also designed specifically for the target group, as it enabled one-on-one sessions with a specialized instructor who provided real-time feedback. A full

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Recruitment was performed in person by the study coordinator. All evaluations were performed in person before and after the 12-week interventional period by an exercise specialist blinded to the group allocation scheme. These details are mentioned in the Participants and Outcome Measures sections of the Methods.
The intervention itself involved one-on-one exercise sessions with a remotely located specialized instructor who performed the exercise together with the participant, supervised the exercise, and provided realtime feedback. These details are mentioned in the Telepresence Exercise Program section of the Methods.

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   We used prompts such as phone calls and SMS to remind the participants regarding the evaluation schedule (approximately three times per participant). Participants in the intervention group had exercise training sessions three times per week. Control subjects were followed-up via phone every two weeks. All participants received exercise education once per month. These details are mentioned in

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   All participants (i.e., intervention and control groups) received nutrition and exercise education: "During the intervention period, nutrition guidance and exercise education were provided to all the participants once every 4 weeks. Throughout the 12-week intervention period, the participants were encouraged to maintain the same physical activity levels and calorie intake as before participating in the study. During the education sessions, we instructed the participants to inform an education instructor regarding any changes in physical activity levels or nutrition 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The study outcomes were physical and psychological risk factors associated with falling. These were assessed one week before and at the end of the 12-week interventional period. All evaluations were performed in person by an exercise specialist blinded to the group allocation scheme. These details are mentioned in the Procedures section of the Methods. A full explanation of the outcomes is 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no changes to the trial outcomes after the trial commenced.

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Power analysis was performed using G*power 3 [20] and revealed that the sample size of 10 and 13 participants for the IG and CG groups, respectively, was sufficient to distinguish an effect size of 0.35 (for lower limb muscle mass) with an α-value (probability of Type 1 error) of 0.05 and statistical power (1-β) of 0.80." 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no interim analyses or stopping guidelines. Participants were free to withdraw at any time.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The remaining 30 women were assigned to either the telepresence exercise intervention group (IG,n=15) or to the control group (CG, n=15). The group allocation scheme, which was based on simple random sampling performed in Microsoft Excel® (2010; Microsoft Corporation, Redmond, WA, USA), was obtained by the research coordinator." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Randomization into two groups was based on simple random sampling and performed using Microsoft Excel. The research coordinator obtained the randomization sequence. The evaluator was blinded to the group allocation scheme.
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The group allocation scheme, which was based on simple random sampling performed in Microsoft Excel®, was obtained by the research coordinator. Due to the nature of the study, the participants could not be blinded. However, all evaluations were performed by an exercise specialist blinded to the group allocation scheme.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The group allocation scheme, which was based on simple random sampling performed in Microsoft Excel®, was obtained by the research coordinator. During the intervention period, telepresence exercise program was provided to all IG participants by an exercise instructor. Nutrition guidance and exercise education were provided to all participants by an education instructor blinded to the group allocation scheme. All evaluations were performed by an exercise 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study was designed as a double-blind, parallel-group, randomized controlled trial." Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There was no placebo or sham intervention in this study.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Two-way repeated-measures analysis of variance (ANOVA) was performed to account for the effect of group (IG and CG), time (pre-and post-test), and interaction between the group and time. When there were significant interaction effects, a paired t-test was used to assess withingroup differences between pre-and post-test measurements. Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were no additional analyses in this study.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was approved by the Seoul National University Hospital Institutional Review Board (approval no. 1412-150-636). All participants provided written informed consent before enrollment, and were free to withdraw from the study at any time."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

RESULTS
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Informed consent procedures were performed in person. Specifically, the research protocol and procedures were explained to the recruited candidates, who then signed the informed consent document in the X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The telepresence platform provides Health Insurance Portability and Accountability Act-compliant security for data transfer (media and signaling) using state-of-the-art encryption standards. No private or identifiable information was sent over the telepresence platform. All exercise sessions were monitored by a specialized instructor who provided real-time feedback. No incidents or adverse events associated with the intervention were noted in this study.
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Such data are provided in Table 1 and Figure 1 (CONSORT flow diagram), as well as in the Methods (Participants) and Results (General Characteristics of the Participants) sections.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This information is provided in the CONSORT flow diagram (Figure 1) , as well as in the Participants section of the Methods.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

14a) Dates defining the periods of recruitment and follow-up
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participation was checked by the instructor during every one-on-one telepresence exercise session. We did not provide an attrition diagram because the participants had almost full attendance. Dropouts are mentioned separately.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Recruitment was performed between February 10th, 2015 and March 8th, 2015. The study period was 3 months for all participants.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No critical "secular events" fell into the study period. All resources were provided to the participants free of charge and ready to use. There was no downtime during the intervention period.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The trial was not stopped early.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The exact number of participants is mentioned for each analysis and result, as well as in the CONSORT flow diagram (Figure 1).

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   We agree that ITT (intention-to-treat) principles are important in randomized controlled trials. For ITT analysis, it is necessary to track randomized participants to obtain data, which is not always easy. In our study, it was not possible to obtain data regarding dropouts due to surgery or flu. On the other hand, all participants included in the final analysis had complete data. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This item is not applicable to this study.

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No injuries or unintended effects were noted in this study.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No privacy breaches or technical problems were noted in this study.
subitem not at all important 1 2 3 4 5 essential DISCUSSION 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 19-ii) Include qualitative feedback from participants or observations from staff/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This item is not applicable to this study.
22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The aims and results are summarized in the first paragraph of the Discussion (Principal Results section). "The objective of this study was to develop a novel telepresence exercise platform based on WebRTC technology, as well as a suitable telepresence exercise program, and to investigate the effect of such a home-based telepresence program (i.e., with real-time supervision and feedback from a specialized instructor) on fall-related risk factors in elderly women. The main finding was that a 12-week telepresence program involving progressive exercise can be effective for enhancing physical performance (chair stand test score), improving balance (BBS score), and reducing fear of falling in elderly women at risk of falls."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study These are listed in the Limitations section of the Discussion. "The present study has several limitations. First, the sample size was relatively small, which precludes generalization of our findings. Second, a cost-benefit analysis for the telepresence exercise platform service was not conducted. Third, follow-up evaluation after 12 weeks is needed to confirm the long-term effects of telepresence exercise."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations subitem not at all important 1 2 3 4 5 essential

23) Registration number and name of trial registry
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The study was focused on elderly individuals with high risk of falls. "…the sample size was relatively small, which precludes generalization of our findings." Additionally, only women were included.