We conducted a single-centered randomized controlled trial with parallel groups between 2021 and 2023 aimed to compare the effect of a home-based lifestyle modification program delivered through telerehabilitation monitoring, combined with supervised sensorimotor training for patients undergoing elective TKA for unilateral OA. This study received approval from the Research and Ethics Committee at Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University, Lahore, Pakistan (REC/RCR&AHS/2033) and was conducted in accordance with the Declaration of Helsinki [15]. The protocol of the study has been officially registered with the clinical study identifier NCT05018494 in the ClinicalTrials.gov Protocols Registration and Results System on May 8, 2021. The participating center in this study was the Physical Therapy department of Ghurki Trust Teaching Hospital, Lahore, which was following the rehabilitation protocol for patients post-knee replacement.

Sample size calculation was conducted using G*Power (version 3.1.9.4; Heinrich Heine University Düsseldorf) based on the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain dimension, which had demonstrated a large effect size (Cohen d=2.0) in previous literature [16], demonstrating substantial differences between the intervention groups (IGs). To ensure adequate power to detect significant changes, the calculation was performed with a significance level (α) of .05 (2-tailed) and a statistical power of 80%. The pooled SD for the KOOS pain dimension was calculated as 11.26, and the mean difference between the experimental and control groups (CGs) was 13.4 points. Based on these parameters, the required sample size was calculated to be 26 participants per group, resulting in a total sample size of 52 participants. This sample size was sufficient to detect meaningful differences in pain outcomes between the groups. Moreover, considering potential participant dropout rates of approximately 10%‐15%, a total of 52 participants were estimated to be adequate to maintain the study’s statistical power.

Eligibility for the study was assessed for all patients who had received an anesthesiologist’s approval and were already scheduled for surgery. Patients were invited to participate in the study, and detailed oral and written explanations were provided about the trial. Those willing to participate were required to sign a written informed consent form. Prior to admission to the hospital, patients completed preoperative outcome assessment questionnaires, including the knee joint function, Berg Balance Scale (BBS), QOL questionnaire, along with objective measures of JPS and cross-sectional area of rectus femoris (RF) through diagnostic musculoskeletal ultrasound (MSK-US).

The inclusion criteria were (1) patients who were men or women, (2) had undergone primary TKA surgery, (3) had the ability to walk (with a walking aid or unaided), (4) were aged between 45 and 75 years, (5) had active knee flexion of 80° and active knee extension of −10° upon discharge, and (6) had the availability of a smartphone and internet service in the residing area.

The exclusion criteria were (1) the presence of health-related medical conditions that could interfere with tests or the rehabilitation program, (2) neurological conditions and vestibular disorders that might affect balance, (3) inability to attend rehabilitation services, revised knee arthroplasty, and (4) blindness and any condition incompatible with 30 minutes of light to moderate physical activity.

Participants were randomized to groups on a 1:1 basis through computer-generated randomization performed by an independent statistician. Following the initial assessment, a volunteer rehabilitation house officer distributed envelopes based on the randomization sequence. These envelopes, which were consecutively numbered, sealed, and opaque, were stored in a secure location accessible only to the unblinded lead researcher-physiotherapist (SS). This physiotherapist (SS) then scheduled the participants’ training session to introduce the web-based rehabilitation lifestyle modification program. Participants reviewed and signed the informed consent form, which adhered to the guidelines of the Helsinki Declaration and outlined the study’s objectives.

Once included in the study, post 2 weeks of knee replacement, patients were randomized into either the IG or the CG. The randomization process was blinded to patients. Patients in the IG and CG received one-on-one 12 weeks of supervised strengthening exercises, neuromuscular electrical stimulation, and sensorimotor training, 3 times a week for 45 minutes to learn strength and sensory-motor exercises. Patients who received any rehabilitation limitations from the surgeon were excluded from the study. At the time of discharge, patients in IG received a web portal link that could be viewed on any smartphone or device with a complete manual on lifestyle modification, constituting 3 sections (Figure 1). The first section included exercises comprising videos of morning, afternoon, and evening, along with clear instructions in the local Urdu language for better understanding (Figure 2). The second section was about a daily diet plan of morning, afternoon, mid-evening, and night meals, considering the optimal caloric balance (Figure 3). The third section was the education section, giving instruction points about safety and daily activities. The CG patients received standard written instructions commonly prescribed as home exercises with oral guidance.

Regular messages and phone calls every week were conducted to follow up with all patients, addressing any possible complications, completion of the training diary, and exercise clarity. The patients had scheduled hospital visits at 3 and 5 months. During the follow-up visit, the physical therapist performed assessments, and patients were asked to fill out questionnaires. Postoperative cross-sectional area of the RF muscle was taken to compare the muscle architecture presurgery, after sensorimotor training, and post home-based exercises. Three readings were taken for all the measures (presurgery, 12 weeks after sensorimotor training, and a further 8 weeks after home-based lifestyle modification implementation). At follow-up, the physiotherapist inquired about any adverse effects or reasons for training cessation from the patients. This comprehensive study design allowed us to assess the effectiveness, safety, and long-term outcomes of a home-based lifestyle modification manual delivered through telerehabilitation monitoring compared with the standard home-based exercises for patients undergoing elective TKA.

Participants maintained compliance through their portal by checking off their exercise, educational, and dietary activities. Any adverse events were promptly reported to the therapist via the WhatsApp button available on the portal. Exercise assurance videos were also sent through WhatsApp for additional guidance. They recorded each exercise performed daily, made notes about any additional sports activities such as walking or stationary bicycling, documented any adverse effects experienced, and provided reasons for skipping any program element if applicable. Participants also used the Visual Analog Scale (VAS) to record their pain levels throughout the day, before and after training sessions, and at night.

All patients received standard physiotherapy care during their hospitalization. This began on the day of surgery and included mobilization using a walking aid (typically 2 crutches, occasionally a walker), exercises to prevent deep vein thrombosis, lower limb range of motion exercises, and an isometric strengthening program. Patients were advised to perform these exercises twice daily, aiming for approximately 10 repetitions of each exercise, and to walk as much as possible. The exercises were conducted in various positions, including supine, on the healthy side, on the abdomen, sitting, and standing (eg, buttock squeezes, leg sliding motions, straight leg raises, bridges, and postural exercises).

The treatment protocol involved a structured regimen starting with 2 weeks of hospital-based bedside and preparatory physiotherapy. This was followed by 12 weeks of supervised strengthening exercises, neuromuscular electrical stimulation, and sensorimotor training, conducted 3 times a week for 45 minutes each session. Additionally, an 8-week lifestyle modification program encompassing education, exercise, and diet was provided to the IG. Common treatments consisted of strengthening exercises, neuromuscular electrical stimulation, and sensorimotor training, all carried out over a 12-week period with sessions 3 times a week for 45 minutes. Each session included routine elements such as warm-up activities involving range-of-motion exercises, stretching, or flexibility exercises; mobility exercises for the lower extremities; and strengthening exercises, including isometric and concentric exercises for the knee quadriceps, hamstrings, and hip abductors. Functional, task-oriented exercises such as stair climbing, squats, stationary cycling, treadmill walking, or regular walking were also part of the regimen, followed by cool-down activities. Concentric mode strengthening exercises were performed using a medium-resistance elastic theraband provided to all patients. The primary focus of the exercises was enhancing sensorimotor functioning. Innovative agility and perturbation training techniques were incorporated, such as side-stepping, backward stepping, and using irregular foam laminations to offer targeted sensorimotor stimulation over unstable surfaces [17]. Exercise challenges and progression were achieved using regular pillows to simulate unstable surfaces, plastic cups to create obstacles, and strategies such as transitioning from bipedal to monopedal stance and from eyes open to eyes closed to increase the difficulty of maintaining or achieving balance. Patients in the CG were given written instructions, handouts with pictorial exercises, and a portal login that provides access to exercise videos along with a checklist to mark daily exercise compliance.

Before discharge, physiotherapists instructed patients in the IG on specialized strength and sensorimotor exercises using various exercise aids along with educational points and a diet plan. These patients also received a web portal login containing exercise videos, written instructions, a diet plan with pictorial representation, and a checklist to track their daily lifestyle routine (Figure 4). The new training protocol included exercises designed to enhance hip stability and decrease local stress on the knee prosthesis. Safety considerations regarding knee, hip, and lumbar spine load; fall prevention; and prosthesis dislocation were integral to the training design [18]. The program encompassed hip and knee muscle strengthening exercises (emphasizing the abductors), hip and pelvic stabilization exercises, ankle and knee muscle strengthening exercises (to better dissipate impact forces and control femoral internal rotation), and trunk muscle strengthening exercises (to stabilize the pelvis and lumbar spine, thereby reducing local loads). The exercises were designed to be simple and easy to understand, with home exercise videos that are straightforward to follow. Additionally, the training program avoided the need for expensive equipment. Focusing on education, physical activity, dietary modifications, weight management, and behavioral changes might lead to better joint health, decreased joint stress, improved functional outcomes, enhanced QOL, and increased long-term success of the TKA procedure. The detailed lifestyle modification plan was attached in the Multimedia Appendix 1.

The primary objective of the study was to evaluate the effectiveness of the chosen protocol, which was assessed through JPS, muscle thickness of the RF, and balance. Secondary outcomes included knee function, and QOL was assessed through patient questionnaires, as well as consistent reporting of any adverse event.

Knee JPS was assessed using a reliable and validated method, incorporating measurements of joint angles through digital photography and nonreflective markers, supported by specialized software. The JPS assessment was performed in a quiet, isolated room. Patients were seated in a high sitting position on a treatment plinth, and testing was conducted on the operated knee. Four square nonreflective markers, each 4 cm in diameter, were placed at specific anatomical landmarks on the lateral side of the limb: First, proximal to a quarter of the distance along a line from the greater trochanter to the lateral joint line of the knee, second, over the neck of the fibula, third over the proximal part of the lateral malleolus, and fourth on the iliotibial tract adjacent to the superior border of the patella. With eyes closed, the patient’s knee was passively moved by the examiner to one of 2 target reference angles, 30° or 60° of knee extension, and held in that position for approximately 5 seconds to allow the patient to internalize the joint position. The limb was then returned to the resting position for 7 seconds. The patient was subsequently asked to actively reproduce the same knee angle. Each angle was tested 3 times, and the average value of the reproduced angles was calculated. A side-view photograph was taken for each trial using an Apple iPhone 14 Pro Max (48 MP camera), positioned 185 cm from the side of the patient and 65 cm above the floor. The angles formed by the markers were analyzed using Paint software by drawing lines between points to measure joint angles, and final values, including the absolute angular error, were calculated and documented in Microsoft Excel. Absolute error was defined as the absolute difference between the target and perceived angles for each of the 3 trials at specified angles for each limb of each participant. Relative error indicates the variability of errors between trials, reflecting the consistency of proprioceptive performance [19].

MSK-US was used using a curvilinear probe operating at frequencies ranging from 7.1 to 14 MHz, along with a 55 mm linear probe. The probe was positioned ventrally in the transverse plane, perpendicular to the skin over the RF muscle. The RF muscle’s location was marked at a point 3/5 of the distance from the anterior superior iliac spine to the superior border of the patella, ensuring that the entire cross-section of the RF is visible within a single field for all patients [20].

Imaging was conducted with patients seated. Gentle contraction and relaxation maneuvers were used to enhance visualization of muscle septa before capturing images. Cross-sectional area, muscle thickness, and width were measured at this specific muscle point, with images taken both in complete relaxation and during contraction.

The original 14-item BBS was used to evaluate balance in older individuals. This scale has been validated, proven reliable, and shown to be responsive in assessing balance. It comprises 14 straightforward balance tasks, each scored on a 5-point ordinal scale (0, 1, 2, 3, and 4), with a maximum possible score of 56. Higher scores on the BBS indicate better balance. This assessment tool is widely used clinically, with all tasks focusing on balance, and has previously been used to evaluate balance in patients recovering from hip fractures and knee arthritis [21].

Knee function was assessed using the KOOS. Originating from the WOMAC Osteoarthritis Index in 1995, the KOOS is a reliable instrument for evaluating symptoms and function in individuals with knee injuries or OA. This self-administered questionnaire takes approximately 10 minutes to complete and encompasses 5 subscales: pain, symptoms other than pain, function in activities of daily living (ADL), function in sports and recreation (Sport/Rec), and knee-related QOL. Scores are reported as percentages ranging from 0 to 100. This comprehensive tool enables both short-term and long-term assessment of various knee conditions, including OA. The Urdu version of the KOOS was used for this evaluation [22].

The EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) was used to assess health-related quality of life (HRQOL). Its conceptual framework takes a holistic approach to health, encompassing not only the medical definition but also the essential aspects of independent physical, emotional, and social functioning. The EQ-5D-5L considers health as a composite of positive elements (well-being) and negative aspects [23]. It comprises a questionnaire and a VAS (EuroQol VAS), where the EuroQol VAS allows individuals to rate their own current overall health status using a VAS [24]. This scale enables continuous monitoring of health changes over time. The self-assessment questionnaire involves the participant describing their current health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participants are asked to assess their level of function in each dimension as severe, moderate, or none.

Participants maintained compliance through their portal by checking off their exercise, educational, and dietary activities. Any adverse events were promptly reported to the therapist via the WhatsApp button available on the portal. Exercise assurance videos were also sent through WhatsApp for additional guidance. They recorded each exercise performed daily, made notes about any additional sports activities such as walking or stationary bicycling, documented any adverse effects experienced, and provided reasons for skipping any program element if applicable. Participants also used the VAS to record their pain levels throughout the day, before and after training sessions, and at night.

All of this information was analyzed to evaluate patient satisfaction, assess the feasibility of the protocols, and ensure their safety.

All data was collected and recorded in hard copy format by the primary author, who bears responsibility for maintaining data confidentiality. Check-up forms were printed and completed preoperatively and at each subsequent check-up by the physiotherapist and orthopedic surgeon. Patients also filled out printed questionnaires during these sessions. The author entered the anonymized data into tables for statistical analysis. Statistical processing was conducted using IBM SPSS Statistics (version 25.0; IBM Corp).

An intention-to-treat analysis was performed to mitigate potential biases arising from missing data in randomized controlled trials. This analytic approach involved analyzing participants based on their original randomized treatment assignment, regardless of whether they completed the treatment as intended. Sensitivity analyses were conducted and reported to address any missing data [25].

Descriptive statistics were presented as mean (SD), and intergroup differences in baseline characteristics will be assessed using an independent t test. The normality of the sampling distribution was evaluated using the Shapiro-Wilk W-test for inferential analysis [26]. Assumptions of sphericity (Mauchly test) and homogeneity of variances (Levene test) were checked prior to analysis. Repeated Measures ANOVA was used to compare mean score changes both between and within groups to evaluate the effects of the intervention. The significance level for all analyses was set at P<.050.

Mixed effects ANOVA assessed the impact of Group (experimental and control), Time (baseline, 14 wk, and 22 wk), and their interaction on each dependent variable. Effect sizes were computed using partial eta squared (η²p), with values between 0.1 and 0.24 indicating a moderate effect, values from 0.25 to 0.36 indicating a medium effect, and values of 0.37 or higher indicating a large effect [27]. To control for potential inflation of Type I error due to multiple outcome measures, the Holm-Bonferroni correction and Benjamini-Hochberg (FDR) methods were applied to P values of all outcomes.

This study was approved by the Research and Ethics Committee at Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University, Lahore, Pakistan (REC/RCR&AHS/2033), and was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. The study protocol was officially registered with ClinicalTrials.gov (Identifier: NCT05018494) on May 8, 2021. Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were fully informed about the study’s purpose, procedures, potential risks, and benefits. To maintain privacy and confidentiality, all collected data were anonymized and securely stored, with access to the telerehabilitation platform restricted to authorized personnel through password-protected accounts. No financial compensation was provided for participation, and all rehabilitation services, materials, portal logins, and digital access were offered free of charge.

This study aimed to evaluate the effectiveness of supervised sensorimotor training with and without a lifestyle modification manual through telerehabilitation monitoring in patients undergoing TKA. The main findings indicate that both groups demonstrated improvements in pain, physical function, balance, joint proprioception, and QOL over time; however, the group receiving the combined intervention of sensorimotor training with lifestyle modification showed significantly greater improvements across almost all outcomes. Notably, enhancements were observed in the muscle thickness (MSK-US), balance (BBS), and all subscales of the KOOS, as well as JPS and HRQOL (EQ-5D-5L). The CG did not receive a structured lifestyle plan emphasizing exercise, diet, and education instructions via a web portal; instead, they were instructed to maintain their usual daily routine. Consistent communication was maintained through the telerehabilitation mode, providing continuous guidance and exercise instructions. Both groups received telerehabilitation monitoring, but the lifestyle modification plan was provided exclusively to the IG. Both groups demonstrated improvement in various outcome measures; however, the experimental group had superior outcomes. Specifically, the experimental group showed greater improvements in functional mobility, pain reduction, musculoskeletal health, balance, knee function, JPS, and overall QOL compared with the CG.

Participants in the experimental group, who received the lifestyle modification plan, showed significantly greater improvements in knee function as measured by the KOOS. The improvements spanned multiple subscales, including Pain, Symptoms, ADL, Sports/Recreation, and QOL. This aligns with previous studies demonstrating the efficacy of comprehensive rehabilitation programs in enhancing knee function postsurgery [28]. However, the addition of lifestyle modifications appears to amplify these benefits, suggesting that addressing behavioral and lifestyle factors plays a crucial role in optimizing recovery [29]. The significant increase in the musculoskeletal cross-sectional area, as measured by MSK-US, further supports the advantage of the combined approach. The experimental group exhibited greater increases in cross-sectional area compared with the CG, indicating enhanced musculoskeletal health and strength. This finding contrasts with earlier studies that focused solely on exercise interventions, which reported modest improvements in muscle mass and strength [30]. The inclusion of lifestyle modifications likely contributed to the observed gains by promoting overall physical health and activity levels. JPS, a critical component of proprioception, showed marked improvements in the experimental group. The reduction in absolute error in JPS was significantly greater for participants receiving lifestyle modifications, suggesting that this comprehensive approach enhances proprioceptive accuracy. Previous research has highlighted the benefits of sensorimotor training in improving proprioception post-TKR. This study extends these findings by demonstrating that lifestyle modifications can further refine proprioceptive function [31]. Similarly, balance, as measured by the BBS, improved more significantly in the experimental group. The substantial gains in balance scores indicate that lifestyle modifications, in conjunction with sensorimotor training, provide a more holistic approach to rehabilitation [32]. These findings are consistent with previous literature that emphasizes the role of balance training in improving postural stability postsurgery [33]. However, this study suggests that incorporating lifestyle changes may lead to even greater improvements in balance and stability.

Pain reduction, as measured by the Numeric Pain Rating Scale, was significantly more pronounced in the experimental group. Participants reported lower pain levels throughout the study period, underscoring the effectiveness of the combined intervention in managing postsurgical pain. This aligns with existing studies that have shown exercise and rehabilitation programs can reduce pain levels [34]. The additional benefit observed in this study may be attributed to lifestyle modifications that address inflammation, diet, and overall well-being, contributing to pain reduction [35]. QOL, assessed using the EQ-5D-5L, showed substantial improvements in the experimental group. The significant gains in HRQOL scores indicate that the combined approach not only enhances physical recovery but also positively impacts overall well-being and satisfaction [36]. These findings resonate with previous research that has demonstrated the positive impact of comprehensive rehabilitation programs on QOL post-TKR [37]. The added value of lifestyle modifications highlights the importance of addressing holistic health factors in rehabilitation programs.

The telerehabilitation monitoring results demonstrated higher adherence rates in the experimental group, suggesting that lifestyle modifications may enhance engagement and compliance with rehabilitation programs [34]. The majority of participants in the experimental group achieved over 90% compliance, indicating that the combined approach was well-received and effectively implemented. These findings are in line with studies emphasizing the role of telerehabilitation in supporting adherence to home-based rehabilitation programs [38]. This study adds to this body of evidence by showing that lifestyle modifications, supported by telerehabilitation, can further improve adherence and outcomes.

To our knowledge, this is the first study of lifestyle modification programs conducted among TKA patients and using the telerehabilitation monitoring method in Pakistan. A noteworthy feature of this study is the translation of the lifestyle modification manual into Urdu, the native language of the Pakistani population. This translation ensured that participants fully understood the lifestyle recommendations and guidelines, thereby enhancing the effectiveness of the intervention. The translation addressed language barriers and made the program more accessible and culturally relevant to the participants, contributing to the high compliance and positive outcomes observed in the experimental group.

However, the study also has certain limitations. The use of a single clinical care ensured superior standardization of care, which can be regarded as a notable benefit in the context of conducting this exploratory and innovative trial. This standardization allowed for consistent and controlled conditions, thereby enhancing the reliability of the results. Nevertheless, the capacity to generalize the findings from this study to other settings, joint systems, and surgical procedures is expected to be limited in comparison to results derived from more diverse multicenter trials. An additional limitation of this innovative study is that, although it was hypothesized that the lifestyle program would enhance participants’ confidence to safely engage in a more physically active lifestyle, physical activity was not directly assessed. Future studies should also focus on assessing the cost-effectiveness of telerehabilitation, predominantly in the framework of developing nations like Pakistan. Evaluating economic feasibility, possible savings, and application barriers could benefit in larger-scale adoption.

Both groups that received sensorimotor training demonstrated improvements in their outcomes. However, the incorporation of a lifestyle modification program in the experimental group yielded significantly better results compared with those who received the standard intervention alone. The experimental group showed superior improvements in knee function, performance, and overall QOL. These findings suggest that integrating a lifestyle modification program with sensorimotor training can enhance rehabilitation outcomes for patients undergoing total knee replacement. In addition, the IG, supported by telerehabilitation monitoring, showed better adherence to the home-based lifestyle modification program compared with the CG, highlighting the potential benefits of telerehabilitation in enhancing compliance and engagement in lifestyle modification rehabilitation programs.