A Dyadic Approach for Promoting Physical Activity Among People With MS and Their Support Partners
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This pilot study will use a two-arm, parallel group, single-blinded RCT design that examines the feasibility and preliminary efficacy of a twelve-week physical activity intervention in persons with moderate-to-severe MS disability and their family caregivers compared with a delayed control condition.Masking: Single (Outcomes Assessor)Masking Description: Outcome assessments will be collected objectively by researchers who are blinded to treatment allocation. Researchers who are involved with delivery of the intervention will be aware of treatment allocation, but will not be involved with data collection, entry or analysis.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is an assessor-blinded pilot randomized controlled trial (RCT) for examining the feasibility and preliminary efficacy of a dyadic PA intervention approach for persons with MS (PwMS) affected by moderate-to-severe disability and their family caregivers (CGs). Dyads who meet the eligibility ...
The study is an assessor-blinded pilot randomized controlled trial (RCT) for examining the feasibility and preliminary efficacy of a dyadic PA intervention approach for persons with MS (PwMS) affected by moderate-to-severe disability and their family caregivers (CGs). Dyads who meet the eligibility requirements will undergo the informed consent process and baseline assessment. Dyads will then be randomized to either an immediate intervention condition or a delayed control condition. Participants in the immediate intervention group will receive six group teleconference sessions, approximately 60 minutes each, every other week for 12 weeks. These sessions will be interspersed with one-on-one support calls in the weeks that group sessions do not occur. Participants will be provided with a manual for their individual use during the intervention. The intervention content will introduce participants to the concepts of shared appraisal and dyadic coping. The benefits of shared participation in PA as a coping strategy to optimize well-being at both the individual and dyadic level will be reinforced and illustrated. All participants will be taught techniques for monitoring PA behaviour, setting personalized goals to increase PA and reduce sedentary time, and strategies for overcoming challenges to PA participation. The one-to-one support calls will serve to reinforce the information provided during the group sessions, monitor safety, and troubleshoot any issues with the intervention content. All participants will undergo the assessment protocol again at 12 weeks.
Tracking Information
- NCT #
- NCT04267185
- Collaborators
- The Ottawa Hospital
- Consortium of Multiple Sclerosis Centers
- Investigators
- Principal Investigator: Lara Pilutti, PhD University of Ottawa Principal Investigator: Mark Freedman, MD The Ottawa Hospital/Ottawa Hospital Research Institute
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