A Dyadic Approach for Promoting Physical Activity Among People with MS

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

CompletedNot a drug-phase studyMS (type not specified)NCT04267185

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Physical Activity Together for PwMS and their CGs (PAT-MS)

What it measured

Main measures

  • Safety of the PAT-MS intervention

    Assessed weekly through study completion at 12 weeks

    RelapsesWalking and mobilitySafety

  • Feasibility: Participant recruitment rate

    Recorded through the 6-month recruitment period

    Feasibility

  • Feasibility: Participant compliance rate

    Recorded weekly through study completion at 12 weeks

    Feasibility

  • Feasibility: Participant attrition rate

    Will be assessed at T2 (12 Weeks)

    Feasibility

  • Feasibility: Monetary cost of research

    Recorded from study initiation to completion, approximately 2 years

    Feasibility

  • Feasibility: Staff time

    Recorded weekly through study completion at 12 weeks

    Feasibility

  • Feasibility: Research ethics procedures

    Recorded from study initiation to completion, approximately 2 years

    Feasibility

  • Feasibility: Data collection at T1

    Will be assessed at T1 (Baseline)

    MRI lesionsFeasibility

  • Feasibility: Data collection at T2

    Will be assessed at T2 (12 Weeks)

    MRI lesionsFeasibility

  • Change in Self-Reported Physical Activity - Primary Efficacy Outcome

    Change in Self-reported PA (total PA minutes) between T1 (Baseline) and T2 (12 Weeks)

    Physical function

Other measures (13)

  • Change in Accelerometer-measured Physical Activity - steps/day

    Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks).

    Physical function

  • Change in Accelerometer-measured Physical Activity - minutes of PA

    Change in accelerometer-measured minutes of PA between T1 (Baseline) and T2 (12 Weeks).

    Physical function

  • Change in Walking Speed

    Change in walking speed between T1 (Baseline) and T2 (12 Weeks).

    Disability progressionWalking and mobility

  • Change in Walking Endurance

    Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks)

    Walking and mobility

  • Change in Agility

    Change in Agility between T1 (Baseline) and T2 (12 Weeks).

    Walking and mobility

  • Change in Physical Functional Limitations and Disability

    Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks).

    Arm and hand function

  • Change in MS Self-Efficacy

    Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks).

  • Change in Quality of Life in PwMS

    Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks).

    Quality of life (reported by participants)

  • Change in Dyadic Relationship Quality

    Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks)

  • Change in Perceptions of Social Support

    Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks).

Who could take part

MS (type not specified) · 18 and over

Show the full 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)

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2020

    2. Main results due

      Jun 2022

    3. Finished

      Oct 2022

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