Monica Busse1, Lori Quinn, Katy Debono, Karen Jones, Johnathan Collett, Rebecca Playle, Mark Kelly, Sharon Simpson, Karianne Backx, David Wasley, Helen Dawes, Anne Rosser. 1. School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom (M.B., L.Q., K.D., K.J.); Movement Science Group, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, United Kingdom (J.C., H.D.); and South East Wales Trials Unit, Institute for Translation, Innovation, Methodology and Engagement, School of Medicine Cardiff University (R.P., M.J.K., S.A.S.), Cardiff Metropolitan University, Cardiff School of Sport (K.B., D.W.), Institute of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University (A.R.), and Cardiff Brain Repair Group, School of BioSciences, Cardiff University (A.R.), Cardiff, United Kingdom. COMMET-HD management group members are Karianne Backx, Monica Busse, Johnny Collett, Helen Dawes, Katy Debono, Sarah Hunt, Karen Jones, Mark Kelly, Andrea H. Nemeth, Rebecca Playle, Lori Quinn, Anne Rosser, Sharon Simpson, and David Wasley.
Abstract
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 (ISRCTN 59910670) 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: 0.4-13.7) 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.Video Abstract available (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A60) for more insights from the authors.
RCT Entities:
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 (ISRCTN 59910670) 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: 0.4-13.7) 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.Video Abstract available (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A60) for more insights from the authors.
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