Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 25, 2020
Date Accepted: Apr 14, 2021
Physical Activity Together for Multiple Sclerosis (PAT-MS): Study protocol for a feasibility randomized controlled trial of a dyadic intervention for people with advanced multiple sclerosis and their care-partners.
ABSTRACT
Background:
Physical activity is beneficial for all people, yet people affected with multiple sclerosis find regular physical activity challenging. These people may include individuals with advanced disability and their care-partners.
Objective:
The objective of this study is to determine the feasibility and preliminary efficacy of a dyadic physical activity intervention for people with multiple sclerosis and their care-partners.
Methods:
The study is a randomized controlled pilot feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate-intervention or delayed control condition. A target of 20 people with multiple sclerosis care-partner dyads will be included. Assessments will occur at baseline and post-intervention. The outcomes will be: i) safety and feasibility measures; ii) physical activity level in both people with multiple sclerosis and their care-partners; iii) multiple sclerosis self-efficacy, resilience, social support, dyadic relationship quality, participation, and quality of life in people with multiple sclerosis; and iv) coping, resilience, social support, dyadic relationship quality, and quality of life in the care-partners. Participant satisfaction with and experience of the intervention will be evaluated using a satisfaction survey and semi-structured interviews.
Results:
As of February 2020, four participants have been recruited into the study. We anticipate completing the study by February 2021.
Conclusions:
This pilot trial will provide critical information on the feasibility and preliminary efficacy of a dyadic physical activity intervention in people with multiple sclerosis who have advanced disability and their care-partners. If the proposed intervention is effective, the data collected from this pilot trial will be used to refine intervention materials and outcome measures in preparation for a definitive randomized controlled trial. Clinical Trial: ClinicalTrials.gov, NCT0267185. Registered 11/02/2020, https://clinicaltrials.gov/ct2/show/NCT04267185?cond=MS&cntry=CA&draw=2&rank=7
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.