Comparison of Telehealth and Onsite Supervised Maintenance Exercise Programs for Adults With Chronic Lung Disease: Protocol for a Pilot Randomized Feasibility Trial.

backgroundChronic lung diseases (CLDs) such as chronic obstructive pulmonary disease, interstitial lung disease, and chronic asthma contribute significantly to the global burden of disease. Pulmonary rehabilitation (PR) is an effective intervention for improving the exercise capacity, increasing the quality of life, and reducing hospitalizations in individuals with CLD. However, benefits from PR quickly decline following discharge from traditional programs. Telerehabilitation (tele-rehab) has emerged as a potential solution for extending the benefits of PR; yet, few studies have compared its efficacy with conventional onsite maintenance rehabilitation.

objectiveThis pilot protocol aims to assess the effectiveness of an 8-week supervised maintenance rehabilitation program delivered onsite or remotely via tele-rehab in patients with CLD.

methodsThis randomized, assessor-blinded feasibility pilot trial will enroll 30 participants who have completed outpatient PR. Participants will be randomized into 2 groups: (1) tele-rehab, involving remotely supervised sessions conducted via videoconferencing or (2) onsite maintenance rehabilitation with in-person sessions. Both groups will receive weekly supervised sessions for 8 weeks facilitated by licensed physical therapists. Assessments will be conducted onsite at baseline, after the 8-week intervention, and at 1-month follow-up by a blinded assessor. The feasibility of the intervention and the study methods will be assessed by the log-in into the number of sessions attended after randomization, the ease of using the equipment and procedures, optimal session length, and adherence to the intervention protocol. Clinical outcomes will include dyspnea and perceived exertion, respiratory muscle strength, physical function, 6-minute walk distance, physical activity, and quality of life. Descriptive statistics with means and standard deviations for continuous and frequency distributions for categorical data will be utilized to report individual and group characteristics. Feasibility outcomes will be compared using independent 2-sided t tests. Between-group comparisons will use mixed analysis of variance, and within-group comparisons will be analyzed with a repeated measures analysis of variance.

resultsRecruitment for this institutional review board-approved study (approval date: July 25, 2023) began in January 2024, with 11 (37%) of the 30 participants enrolled to date. This study will generate data comparing tele-rehab and onsite rehabilitation in terms of the primary and secondary outcomes. Use data such as program adherence and attrition will also be reported. The results will inform the feasibility, adherence, and effectiveness of tele-rehab as a sustainable alternative to onsite maintenance rehabilitation. The study is anticipated to be completed by April 2026.

conclusionsThis study hypothesizes that both tele-rehab and onsite programs will significantly improve clinical outcomes, with tele-rehab yielding comparable benefits to onsite maintenance. Findings will provide evidence supporting accessible and sustainable maintenance rehabilitation options for patients with CLD and guide future large-scale efficacy trials.

trial registrationClinicalTrials.gov NCT06304207; https://clinicaltrials.gov/study/NCT06304207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71039.