JMIR Publications

ABSTRACT

Background:

Background:

Knee osteoarthritis is a prevalent chronic condition associated with pain, functional limitations, and reduced quality of life. Exercise is the cornerstone of nonpharmacological management; however, long-term adherence to exercise programs remains challenging. Telerehabilitation has emerged as a promising strategy to improve access to supervised exercise, yet evidence comparing synchronous and asynchronous delivery formats, particularly in developing countries, is limited. This study protocol describes a randomized clinical trial designed to compare the effects of synchronous and asynchronous telerehabilitation exercise programs on pain, physical function, quality of life, and exercise adherence in individuals with knee osteoarthritis.

Methods:

This single-center randomized clinical trial will include individuals aged 40–75 years with clinical and/or radiographic knee osteoarthritis. Participants will be randomly allocated to a synchronous or asynchronous telerehabilitation exercise program delivered over six weeks. Both groups will follow an identical, structured exercise protocol, differing only in delivery mode. Outcomes will be assessed at baseline and post-intervention. The primary outcome is pain and physical function. Secondary outcomes include quality of life, functional performance, and exercise adherence. The study protocol was adjusted following a preliminary feasibility study to optimize intervention delivery and monitoring procedures.

Results:

This study did not receive specific funding. The authors received individual scholarships and research support from CAPES and FUNDECT. Data collection began in August 2024, and by October 2025, a total of 30 participants had been recruited. Data analysis is currently ongoing. Manuscript preparation is expected to begin in May 2026, with submission planned for December 2026. Discussion: This trial will provide evidence regarding the feasibility, adherence, and potential effectiveness of different telerehabilitation delivery formats for individuals with knee osteoarthritis. Findings may inform the development of accessible, low-cost rehabilitation strategies in settings with limited access to in-person care. Trial Registration: Brazilian Registry of Clinical Trials (REBEC): RBR-3kzr42p; https://ensaiosclinicos.gov.br/rg/RBR-3kzr42p

Objective:

Therefore, this study protocol describes a randomized clinical trial designed to evaluate the effects of two telerehabilitation exercise programs—synchronous (online) and asynchronous—on pain, functional capacity, and quality of life in individuals with knee osteoarthritis over a six-week intervention period.

Methods:

2.2 Study Design and Reporting Guidelines This study protocol describes a single-center, randomized clinical trial with a quantitative approach, designed to compare two telerehabilitation exercise programs—synchronous and asynchronous—in individuals with knee osteoarthritis (Figure 1). The methodology was developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines29. A completed SPIRIT checklist is provided as Multimedia Appendix 1. The trial results will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines30. The study will be conducted in Campo Grande, Mato Grosso do Sul, Brazil. Participants will be recruited from the community through advertisements on social media, local health services, and university outreach initiatives. All baseline and postintervention assessments will be performed in person at the facilities of the Federal University of Mato Grosso do Sul (UFMS). The study will include two parallel groups and two assessment time points: baseline (pre-intervention) and post-intervention, following a six-week exercise program. Outcome assessment will be conducted by a blinded assessor who will have no involvement in the interventions or outcome testing sessions. Due to the nature of the exercise intervention, blinding of the supervising physical therapists will not be feasible. The statistician will remain blinded to group allocation until completion of all statistical analyses. To minimize the risk of performance bias arising from the lack of therapist blinding, standardized training and detailed standard operating procedures will be implemented. Before the development of the final study protocol, a preliminary feasibility study was conducted with a small sample of nine individuals with knee osteoarthritis. This preliminary phase aimed to assess the feasibility of recruitment procedures, outcome assessment tools, intervention delivery formats, exercise progression, and participants’ understanding of the instructional materials. Findings from this feasibility study informed methodological refinements and optimization of the intervention protocol. 2.3 Ethical Approval and Trial Registration The study was approved by the Human Research Ethics Committee of the Federal University of Mato Grosso do Sul (UFMS) (protocol No. 5,833,392). The trial was prospectively registered in the Brazilian Registry of Clinical Trials (REBEC) under the identifier RBR-3kzr42p (https://ensaiosclinicos.gov.br/rg/RBR-3kzr42p). 2.4 Participants Individuals of both sexes, aged between 40 and 75 years, with a clinical and/or radiographic diagnosis of knee osteoarthritis and symptoms lasting at least three months will be eligible for inclusion. Additional inclusion criteria include access to the internet, availability to attend in-person assessments at baseline and post-intervention, and the ability to provide written informed consent. Exclusion criteria will include a history of knee arthroplasty or surgery, other causes of knee symptoms (such as inflammatory joint diseases, tumors, or patellar tendinopathy), conditions considered more disabling than knee osteoarthritis (e.g., generalized chronic pain or fibromyalgia), medical contraindications to physical exercise (including cardiovascular, respiratory, or neurological conditions), inability to perform basic functional tasks, or participation in another physical therapy or rehabilitation program during the study period. 2.5 Recruitment Procedures Eligible individuals who agree to participate will be scheduled for an initial in-person assessment, during which eligibility will be confirmed and written informed consent will be obtained. Following baseline assessment, participants will be randomly allocated in a 1:1 ratio to either the synchronous or asynchronous telerehabilitation group. Randomization will be performed by an independent researcher using an online randomization tool. Allocation concealment will be ensured through the use of sequentially numbered, sealed, opaque envelopes. 2.6 Exercise Protocol All participants will receive a support kit at the beginning of the study, consisting of a light-resistance miniband, a pair of 1-kg dumbbells, an exercise diary, and an illustrated booklet (Appendix 2) containing detailed descriptions and photographs of all exercises (Figure 2), organized according to progression levels (Figure 3). Before initiating the program, participants will receive instructions regarding study objectives, intervention schedule, and safety procedures. Adverse events will be monitored throughout the study and recorded at each follow-up contact. The exercise intervention will be delivered over six weeks, with sessions performed three times per week, each lasting approximately 45–50 minutes. The exercise protocol will be identical for both groups, differing only in the mode of delivery. The program is organized in a circuit format and includes exercises targeting the upper body, lower body, and trunk or global movements. A total of 47 exercises were selected (see Additional file 1) and categorized according to stress intensity (light, moderate, and high). The program comprises four progressive levels, color-coded as follows: yellow (level 1), blue (level 2), green (level 3), and orange (level 4). Each level includes 10 exercises targeting warm-up activities, quadriceps, hamstrings, hip abductors, hip adductors, and deep abdominal muscles. Participants will begin at level 1 and progress weekly based on pain intensity and perceived exertion, monitored using the Numerical Pain Rating Scale and the Borg CR10 scale (Table 1). Participants allocated to the synchronous group will perform exercise sessions through individual video calls via WhatsApp, with real-time supervision by the principal investigator. Session schedules will be defined collaboratively with participants before the intervention. Participants allocated to the asynchronous group will receive pre-recorded exercise videos in addition to the exercise booklet and will perform the sessions independently at home. Exercise schedules for this group will be established individually via telephone contact, and weekly phone calls will be conducted throughout the intervention period to provide motivation, technical support, and adherence monitoring. Participants may discontinue the intervention at any time upon request. Additionally, discontinuation will occur if participants experience adverse events that contraindicate continuation, significant worsening of symptoms, or any medical condition that limits safe participation in the exercise program. In such cases, participants will be referred for appropriate clinical evaluation. Any modifications to the intervention will be documented and justified. Participants will be instructed to maintain their usual medical care throughout the study period. The initiation of new physical therapy or structured exercise programs outside the study will not be permitted during the intervention period. Any changes in medication or health status will be recorded and considered during data analysis. 2.7 Outcome Measures Outcome assessments will be conducted at baseline and after completion of the six-week intervention period. The primary outcome will be pain and physical function, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include quality of life, assessed using the World Health Organization Quality of Life questionnaire (WHOQOL-BREF); functional performance, measured by the 40-meter fast-paced walk test, the 30-second sit-to-stand test, and the stair climb test; and exercise adherence, assessed using the Exercise Adherence Rating Scale. Sample size was calculated using G*Power software based on effect size (ES) estimates obtained from the preliminary feasibility study. Assuming an alpha level of 5%, statistical power of 80%, and an ES of 0.49 for analysis of variance, a minimum of 59 participants will be required. To account for potential loss to follow-up, a total sample size of 71 participants is planned. 2.8 Statistical Analysis Data analysis will be performed using Statistical Package for the Social Sciences version 20.0 (SPSS Inc., Chicago, IL, USA). An intention-to-treat analysis will be conducted for all data analyses. Descriptive statistics will be used to characterize the sample. Baseline differences between groups will be examined using chi-square tests for categorical variables and independent t tests for continuous variables. Intervention effects will be analyzed using two-way repeated measures analysis of variance to assess group-by-time interactions, following the intention-to-treat principle. When assumptions for parametric analyses are not met, appropriate nonparametric tests will be applied. Training effects will additionally be expressed as a percent change from baseline. Between-group ES will be calculated at post-intervention (week 6) using Cohen's d. ES will be interpreted according to the benchmarks proposed by Cohen (1988): small (0.1 ≤ ES < 0.3), moderate (0.3 ≤ ES < 0.5), and large (ES ≥ 0.5). Additionally, a post-hoc power analysis will be conducted to determine the statistical power achieved by the study, considering the observed ES and the adopted significance level (α = 0.05). A significant level of p ≤ 0.05 will be adopted. 2.9 Data Management and Confidentiality All data collected during the study will be anonymized and coded to ensure participant confidentiality. Data will be stored in password-protected electronic databases accessible only to authorized members of the research team. Physical documents will be securely stored in locked cabinets at the Federal University of Mato Grosso do Sul. Personal identifiers will be removed prior to analysis to maintain data privacy. The results of this study will be disseminated through publication in peer-reviewed scientific journals and presentations at national and international conferences. Findings may also be shared with participants and relevant stakeholders in accessible formats. Authorship will be determined in accordance with international guidelines.

Results:

3 RESULTS Data collection began in August 2024. As of October 2025, a total of 30 participants had been recruited and enrolled in the study. Recruitment is ongoing, and the target sample size has not yet been reached. Baseline assessments have been completed for all enrolled participants, and the intervention phase is currently in progress. No major protocol deviations have been identified to date. Data analysis is currently underway. Final results are expected following completion of data collection and analysis. Manuscript preparation is scheduled to begin in May 2026, with submission of the main trial results planned for December 2026.

Conclusions:

This randomized controlled trial protocol aims to evaluate the feasibility, adherence, and potential effectiveness of synchronous and asynchronous telerehabilitation exercise programs for individuals with knee osteoarthritis. By comparing two structured remote delivery formats, this study seeks to contribute to evidence-based decision-making regarding accessible rehabilitation strategies. The findings may help inform the development of scalable and cost-effective approaches to support the long-term management of knee osteoarthritis and expand access to rehabilitation services. Clinical Trial: Brazilian Registry of Clinical Trials (REBEC): RBR-3kzr42p; https://ensaiosclinicos.gov.br/rg/RBR-3kzr42p