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A randomized feasibility study of a 12-week community-based exercise program for people with Huntington's disease
Busse M, Quinn L, Debono K, Jones K, Collett J, Playle R, Kelly M, Simpson S, Backx K, Wasley D, Dawes H, Rosser, Members of the Commet-HD Management Group
Journal of Neurologic Physical Therapy 2013 Dec;37(4):149-158
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND AND PURPOSE: The beneficial role of exercise as a treatment approach in Huntington's disease (HD) has support from both preclinical work and small-scale studies; however, there have been no controlled studies of gym-based exercise in people with HD. This phase 2 randomized trial (ISRCTN59910670) assessed feasibility, safety, acceptability, and benefit of a structured exercise program. METHODS: Thirty-one participants (16 men; mean (SD) age 50.4 (11.4) years) were randomly allocated to intervention (n = 16) or control group (usual care; n = 15). The intervention entailed a weekly supervised gym session of stationary cycling and resistance exercises, and a twice weekly independent home-based walking program. Retention and adherence rates and adverse events were recorded. Acceptability was determined from subjective reports of tolerability and physiological measures recorded during the gym sessions. Assessment of benefit included measures of physical abilities, disease severity, and quality of life (36-Item Short Form Health Survey). Analysis of covariance was used to test outcomes of interest. RESULTS: The retention rate was 81% (9 of the 11 individuals who started the intervention completed it) and of the 9 who completed the program, 7 attended more than 75% (9/12) of the gym sessions. There were no related adverse events and the intervention was well tolerated by most participants. The between-group effect estimate for the Mental Component Summary score of the 36-Item Short Form Health Survey (n = 9; intervention, n = 13; control) was 7 (95% CI 0.4 to 13.7) Moderate effect sizes for cognitive outcomes and measures of walking were also observed. DISCUSSION AND CONCLUSIONS: Observed effect sizes for clinical outcomes suggest the structured exercise program has benefit for persons with HD; larger scale trials are warranted.

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