Physical activity and exercise outcomes in Huntington's disease (PACE-HD): results of a 12-month trial-within-cohort feasibility study of a physical activity intervention in people with Huntington's disease.

Autor: Quinn L; Dept of Biobehavioral Sciences, Teachers College, Columbia University, NY, NY, USA; Centre for Trials Research, Cardiff University, UK., Playle R; Centre for Trials Research, Cardiff University, UK., Drew CJG; Centre for Trials Research, Cardiff University, UK., Taiyari K; Centre for Trials Research, Cardiff University, UK., Williams-Thomas R; Centre for Trials Research, Cardiff University, UK., Muratori LM; George-Huntington-Institute and Institute for Clinical Radiology, University of Münster, Münster, Germany; Stony Brook University, Stony Brook, NY, USA., Hamana K; School of Healthcare Sciences, Cardiff University, UK., Griffin BA; RAND Corporation, Arlington, VA, USA., Kelson M; Department of Mathematics, Exeter University, Exeter, UK., Schubert R; George-Huntington-Institute and Institute for Clinical Radiology, University of Münster, Münster, Germany., Friel C; Feinstein Institutes for Medical Research, Northwell Health, NY, NY, UK., Morgan-Jones P; Centre for Trials Research, Cardiff University, UK; School of Engineering, Cardiff University, Cardiff, UK., Rosser A; Schools of Medicine and Biosciences, Cardiff University, Cardiff, UK., Busse M; Centre for Trials Research, Cardiff University, UK. Electronic address: busseme@cardiff.ac.
Jazyk: angličtina
Zdroj: Parkinsonism & related disorders [Parkinsonism Relat Disord] 2022 Aug; Vol. 101, pp. 75-89. Date of Electronic Publication: 2022 Jun 29.
DOI: 10.1016/j.parkreldis.2022.06.013
Abstrakt: Introduction: While physical activity (PA) is recognized as important in Huntington's disease (HD) disease management, there has been no long-term evaluation undertaken. We aimed to evaluate the feasibility of a nested (within cohort) randomized controlled trial (RCT) of a physical therapist-led PA intervention.
Methods: Participants were recruited from six HD specialist centers participating in the Enroll-HD cohort study in Germany, Spain and U.S. Assessments were completed at baseline and 12 months and linked to Enroll-HD cohort data. Participants at three sites (cohort) received no contact between baseline and 12 month assessments. Participants at three additional sites (RCT) were randomized to PA intervention or control group. The intervention consisted of 18 sessions delivered over 12 months; control group participants received no intervention, however both groups completed monthly exercise/falls diaries and 6-month assessments.
Results: 274 participants were screened, 204 met inclusion criteria and 116 were enrolled (59 in cohort; 57 in RCT). Retention rates at 12-months were 84.7% (cohort) and 79.0% (RCT). Data completeness at baseline ranged from 42.3 to 100% and at 12-months 19.2-85.2%. In the RCT, there was 80.5% adherence, high intervention fidelity, and similar adverse events between groups. There were differences in fitness, walking endurance and self-reported PA at 12 months favoring the intervention group, with data completeness >60%. Participants in the cohort had motor and functional decline at rates comparable to previous studies.
Conclusion: Predefined progression criteria indicating feasibility were met. PACE-HD lays the groundwork for a future, fully-powered within cohort trial, but approaches to ensure data completeness must be considered.
Clinicaltrials: GOV: NCT03344601.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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