A Dyadic Approach for Promoting Physical Activity Among People with MS and Their Support Partners

NCT04267185 | Completed

• 1 other identifier: 20190329-01H
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exercise; Caregiver; Physical Activity

Outcome Measures

Primary Outcomes (10)

• Safety of the PAT-MS intervention

  Safety will be recorded via reporting of adverse events (AEs) during testing sessions and one-on-one support calls. AEs will be defined as any unfavorable change in health that occurs in both PwMS and CGs during the trial period, e.g. injuries, relapses, falls and symptomatic changes. Each AE will be rated based on severity, expectedness, and potential relation to study participation using the Common Terminology for Adverse Events (CTCAE) classification scheme. AEs will be reported as the overall rate, severity, and characteristics of the events.

  Assessed weekly through study completion at 12 weeks

• Feasibility: Participant recruitment rate

  We will use phone call and electronic mail recruitment and record all contact with potential participants and refusal reasons.

  Recorded through the 6-month recruitment period

• Feasibility: Participant compliance rate

  Will be assessed by recording the number of practice activities, group teleconference sessions, and one-on-one phone calls completed by participants.

  Recorded weekly through study completion at 12 weeks

• Feasibility: Participant attrition rate

  Will be assessed as the percentage of the sample who drop out of the study.

  Will be assessed at T2 (12 Weeks)

• Feasibility: Monetary cost of research

  We will establish and record all monetary costs for the study.

  Recorded from study initiation to completion, approximately 2 years

• Feasibility: Staff time

  We will document all preparation, call time, attempted call time and report-taking time for each participant during the intervention.

  Recorded weekly through study completion at 12 weeks

• Feasibility: Research ethics procedures

  We will document communications between the research ethics board and staff, and time from submission of research ethics application to approval.

  Recorded from study initiation to completion, approximately 2 years

• Feasibility: Data collection at T1

  We will check for data completeness, and record time to collect, enter and check data in a database

  Will be assessed at T1 (Baseline)

• Feasibility: Data collection at T2

  We will check for data completeness, and record time to collect, enter and check data in a database

  Will be assessed at T2 (12 Weeks)

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

  Change in Self-reported physical activity (PA) level of PwMS and CGs will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The GLTEQ has been demonstrated to be a reliable and valid primary outcome for measuring change in PA in response to a behavioural intervention.

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

Secondary Outcomes (13)

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

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

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

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

• Change in Walking Speed

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

• Change in Walking Endurance

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

• Change in Agility

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

Other Outcomes (3)

• Satisfaction Survey

  T2 (12 Weeks)

• Experiential Aspects of Participation

  T2 (12 Weeks)

• Semi-structured Qualitative Interview

  T2 (12 Weeks)

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

PwMS-CG dyads will receive six group telerehabilitation sessions (\~60 min each) every other week for a period of 12 weeks. This will be interspersed with brief one-on-one support telephone calls in the weeks that group sessions do not occur. 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. Make-up sessions will be offered to those who miss group sessions. The one-on-one support telephone calls will serve to reinforce the information provided during the group sessions, monitor safety and troubleshoot any issues with intervention content.

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

Delayed Control

NO INTERVENTION

The delayed control group will not receive the intervention during the study period. Participants assigned to the control group will be offered the intervention once the study is completed.

Interventions

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

A dyadic physical activity intervention approach for PwMS and their family CGs affected by moderate-to-severe MS disability.

Immediate Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• diagnosis of other neurological condition(s)

Sponsors & Collaborators

• University of Ottawa: lead
• The Ottawa Hospital: collaborator
• Consortium of Multiple Sclerosis Centers: collaborator
• Queen's University: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (5)

• 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.

  PMID: 28722772 BACKGROUND

• 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.

  PMID: 29958014 BACKGROUND

• 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.

  PMID: 30745723 BACKGROUND

• Fakolade A, Awadia Z, Cardwell K, McKenna O, Venasse M, Hume T, Ludgate J, Freedman MS, Finlayson M, Latimer-Cheung AE, Pilutti LA. Physical Activity Together for Multiple Sclerosis (PAT-MS): A randomized controlled feasibility trial of a dyadic behaviour change intervention. Contemp Clin Trials Commun. 2023 Oct 16;36:101222. doi: 10.1016/j.conctc.2023.101222. eCollection 2023 Dec.

  PMID: 37928934 DERIVED

• 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.

  PMID: 34061040 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Lara Pilutti, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Mark Freedman, MD

  The Ottawa Hospital/Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 12, 2020
• Study Start: February 4, 2020
• Primary Completion: June 12, 2022
• Study Completion: October 4, 2022
• Last Updated: December 12, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)