Regular submaximal strengthening exercises are recommended for patients with Duchenne muscular dystrophy (DMD); however, evidence regarding the optimal intensity is limited. To evaluate the effects of a 12-month home-based strength training program at different intensities on muscle strength and physical function in boys with DMD and inform the design of a future definitive randomized controlled trial (RCT). Single-site, parallel-group, exploratory pilot RCT. Sixty boys aged 5–10 years with DMD will be randomized in a 1:1:1 ratio to non-resistance, low-resistance, or moderate-resistance strength training groups. All groups will perform a standardized exercise regimen thrice weekly for 12 months at home, including warm-up, static stretching, and strengthening exercises. Training will be initiated through a face-to-face instructional session. Adherence and safety will be monitored using exercise logs and biweekly telephonic assessments. Primary and secondary outcomes will be assessed at baseline, 6 months, and 12 months by blinded outcome assessors. Primary outcome measures are muscle strength and the North Star Ambulatory Assessment. Secondary outcomes include the Motor Function Measure, timed function tests, range of motion, and Vignos and Brooke scales. The exploratory outcomes comprise feasibility (eligibility, recruitment rate, intervention adherence, and study completion rate), tolerability (nonadherence and withdrawal), and safety (adverse events, serum creatine kinase levels, and muscle pain). This Chinese exploratory RCT will provide critical data on the preliminary effects and feasibility of home-based strength training at different intensities in DMD. These findings will guide sample size calculation and outcome selection for larger multicenter trials.
Li et al. (Sun,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: