Clinical trial NCT04267185: A Dyadic Approach for Promoting Physical Activity Among People with MS and Their Support Partners
Official title: Physical Activity Together for MS (PAT-MS): Pilot Study of a Dyadic Rehabilitation Intervention for People with Moderate-to-Severe Multiple Sclerosis Disability and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Caregiver
Physical Activity
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: Consortium of Multiple Sclerosis Centers
name: Queen's University
First posted: 2020-02-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: Both people with multiple sclerosis (MS) and their family caregivers experience the impact of this neurodegenerative disease on their health and well-being. The person living with MS and their support partner need to work together as a team to find ways to manage the disease. A physical activity (PA) program that uses a 'dyadic approach' is one possible way of managing the impact of MS. Dyadic programs are unique because they target both people with the disease and their caregivers together to increase their PA levels. This pilot study will deliver a 12-week program using group teleconference and one-on-one support phone calls to teach participants simple methods to change PA patterns in daily life. For example, they will learn how to set personal goals to increase PA and reduce sitting time.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

For persons with MS:

* Physician-confirmed MS diagnosis and stable course of disease modifying therapies over the past 6 months
* Expanded Disability Status Scale (EDSS) score between 6.0 (intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting) and 6.5 (constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting), based on a Neurostatus-certified assessor examination.
* Relapse-free in the past 30 days
* Support Partner (i.e., relative or close friend) who provides greater than or equal to 1.0 hours per day of unpaid care

Additional inclusion criteria for both persons with MS and caregivers:

* Greater than or equal to 18 years of age
* Currently inactive (i.e., purposeful exercise less than or equal to 2 days/week for 30 minutes)
* Asymptomatic (i.e. no major signs or symptoms of acute or uncontrolled cardiovascular, metabolic, or renal disease) based on the Get Active Questionnaire
* Ability to communicate in English

Exclusion Criteria for both persons with MS and caregivers:

* diagnosis of other neurological condition(s)

Primary outcomes:
measure: Safety of the PAT-MS intervention
timeFrame: Assessed weekly through study completion at 12 weeks
measure: Feasibility: Participant recruitment rate
timeFrame: Recorded through the 6-month recruitment period
measure: Feasibility: Participant compliance rate
timeFrame: Recorded weekly through study completion at 12 weeks
measure: Feasibility: Participant attrition rate
timeFrame: Will be assessed at T2 (12 Weeks)
measure: Feasibility: Monetary cost of research
timeFrame: Recorded from study initiation to completion, approximately 2 years
measure: Feasibility: Staff time
timeFrame: Recorded weekly through study completion at 12 weeks
measure: Feasibility: Research ethics procedures
timeFrame: Recorded from study initiation to completion, approximately 2 years
measure: Feasibility: Data collection at T1
timeFrame: Will be assessed at T1 (Baseline)
measure: Feasibility: Data collection at T2
timeFrame: Will be assessed at T2 (12 Weeks)
measure: Change in Self-Reported Physical Activity - Primary Efficacy Outcome
timeFrame: Change in Self-reported PA (total PA minutes) between T1 (Baseline) and T2 (12 Weeks)
Secondary outcomes:
measure: Change in Accelerometer-measured Physical Activity - steps/day
timeFrame: Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Accelerometer-measured Physical Activity - minutes of PA
timeFrame: Change in accelerometer-measured minutes of PA between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Walking Speed
timeFrame: Change in walking speed between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Walking Endurance
timeFrame: Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks)
measure: Change in Agility
timeFrame: Change in Agility between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Physical Functional Limitations and Disability
timeFrame: Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks).
measure: Change in MS Self-Efficacy
timeFrame: Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Quality of Life in PwMS
timeFrame: Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Dyadic Relationship Quality
timeFrame: Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks)
measure: Change in Perceptions of Social Support
timeFrame: Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Resilience
timeFrame: Change in Resilience between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Coping
timeFrame: Change in Coping in CGs between T1 (Baseline) and T2 (12 Weeks).
measure: Change in Quality of Life in Caregivers
timeFrame: Change in Quality of life in CGs between T1 (Baseline) and T2 (12 Weeks).
Other outcomes:
measure: Satisfaction Survey
timeFrame: T2 (12 Weeks)
measure: Experiential Aspects of Participation
timeFrame: T2 (12 Weeks)
measure: Semi-structured Qualitative Interview
timeFrame: T2 (12 Weeks)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Lara Pilutti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital/Ottawa Hospital Research Institute
name: Mark Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fakolade A, Lamarre J, Latimer-Cheung A, Parsons T, Morrow SA, Finlayson M. Understanding leisure-time physical activity: Voices of people with MS who have moderate-to-severe disability and their family caregivers. Health Expect. 2018 Feb;21(1):181-191. doi: 10.1111/hex.12600. Epub 2017 Jul 19.
citation: Fakolade A, Latimer-Cheung A, Parsons T, Finlayson M. A concerns report survey of physical activity support needs of people with moderate-to-severe MS disability and family caregivers. Disabil Rehabil. 2019 Dec;41(24):2888-2899. doi: 10.1080/09638288.2018.1479781. Epub 2018 Jun 29.
citation: Fakolade A, Finlayson M, Parsons T, Latimer-Cheung A. Correlating the Physical Activity Patterns of People with Moderate to Severe Multiple Sclerosis Disability and Their Family Caregivers. Physiother Can. 2018 Fall;70(4):373-381. doi: 10.3138/ptc.2017-36.ep.
citation: Fakolade A, Cameron J, McKenna O, Finlayson ML, Freedman MS, Latimer-Cheung AE, Pilutti LA. Physical Activity Together for People With Multiple Sclerosis and Their Care Partners: Protocol for a Feasibility Randomized Controlled Trial of a Dyadic Intervention. JMIR Res Protoc. 2021 Jun 1;10(6):e18410. doi: 10.2196/18410.