Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dyadic Approach for Promoting Physical Activity Among People With MS and Their Support Partners (PAT-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267185
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
The Ottawa Hospital
Consortium of Multiple Sclerosis Centers
Information provided by (Responsible Party):
Lara Pilutti, University of Ottawa

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Physical Activity Together for PwMS and their CGs (PAT-MS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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
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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention
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)
A dyadic physical activity intervention approach for PwMS and their family CGs affected by moderate-to-severe MS disability.

No Intervention: Delayed Control
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.



Primary Outcome Measures :
  1. Safety of the PAT-MS intervention [ Time Frame: Assessed weekly through study completion at 12 weeks ]
    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.

  2. Feasibility: Participant recruitment rate [ Time Frame: Recorded through the 6-month recruitment period ]
    We will use phone call and electronic mail recruitment and record all contact with potential participants and refusal reasons.

  3. Feasibility: Participant compliance rate [ Time Frame: Recorded weekly through study completion at 12 weeks ]
    Will be assessed by recording the number of practice activities, group teleconference sessions, and one-on-one phone calls completed by participants.

  4. Feasibility: Participant attrition rate [ Time Frame: Will be assessed at T2 (12 Weeks) ]
    Will be assessed as the percentage of the sample who drop out of the study.

  5. Feasibility: Monetary cost of research [ Time Frame: Recorded from study initiation to completion, approximately 2 years ]
    We will establish and record all monetary costs for the study.

  6. Feasibility: Staff time [ Time Frame: Recorded weekly through study completion at 12 weeks ]
    We will document all preparation, call time, attempted call time and report-taking time for each participant during the intervention.

  7. Feasibility: Research ethics procedures [ Time Frame: Recorded from study initiation to completion, approximately 2 years ]
    We will document communications between the research ethics board and staff, and time from submission of research ethics application to approval.

  8. Feasibility: Data collection at T1 [ Time Frame: Will be assessed at T1 (Baseline) ]
    We will check for data completeness, and record time to collect, enter and check data in a database

  9. Feasibility: Data collection at T2 [ Time Frame: Will be assessed at T2 (12 Weeks) ]
    We will check for data completeness, and record time to collect, enter and check data in a database

  10. Change in Self-Reported Physical Activity - Primary Efficacy Outcome [ Time Frame: Change in Self-reported PA (total PA minutes) between T1 (Baseline) and T2 (12 Weeks) ]
    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.


Secondary Outcome Measures :
  1. Change in Accelerometer-measured Physical Activity - steps/day [ Time Frame: Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks). ]
    Accelerometer-measured PA will be assessed as steps/day in both PwMS and CGs. At each assessment session, both PwMS and CGs will be provided with an Actigraph Activity monitor (accelerometer) to take home, along with a logbook to record the time periods in which the accelerometer was worn. Participants will be instructed to wear the accelerometer during all waking hours, except while engaging in water activities.

  2. Change in Accelerometer-measured Physical Activity - minutes of PA [ Time Frame: Change in accelerometer-measured minutes of PA between T1 (Baseline) and T2 (12 Weeks). ]
    Accelerometer-measured PA will be assessed as minutes spent in sedentary behaviour, light activity, and moderate-to-vigorous activity in both PwMS and CGs. At each assessment session, both PwMS and CGs will be provided with an Actigraph Activity monitor (accelerometer) to take home, along with a logbook to record the time periods in which the accelerometer was worn. Participants will be instructed to wear the accelerometer during all waking hours, except while engaging in water activities.

  3. Change in Walking Speed [ Time Frame: Change in walking speed between T1 (Baseline) and T2 (12 Weeks). ]
    Walking speed will be assessed in PwMS using the timed 25-foot walk (T25FW) test. The T25FW test will involve participants walking as quickly and safely as possible across a 25-foot distance. Participants will be asked to complete two walking trials and the average walking speed of the two trials will be reported in meters/second.

  4. Change in Walking Endurance [ Time Frame: Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks) ]
    Walking endurance will be assessed in PwMS using the 2-minute walk (2MW) test. The 2MW test involves participants walking as fast and as far as possible in an accessible hallway for 2 minutes. Participants will complete one walking trial.

  5. Change in Agility [ Time Frame: Change in Agility between T1 (Baseline) and T2 (12 Weeks). ]
    Agility will be assessed in PwMS using the Timed Up-and-Go (TUG) test. The TUG test involves participants rising from a chair, walking 3 meters, turning around, and then walking back to the chair and returning to the seated position. Participants will complete two trials of the TUG test. The time taken in seconds for each trial will be recorded.

  6. Change in Physical Functional Limitations and Disability [ Time Frame: Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks). ]
    Physical functional limitations and disability will be assessed in PwMS using the abbreviated Late-Life Function and Disability Instrument (LLFDI) questionnaire. The LLFDI contains fifteen items within 3 subscales: basic lower extremity function, advanced lower extremity function, and upper extremity function. A composite score is generated by summing all three subscale scores. Higher scores indicate fewer functional limitations.

  7. Change in MS Self-Efficacy [ Time Frame: Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks). ]
    Self-efficacy will be assessed in PwMS using the MS Self-Efficacy (MSSE) Scale. The questionnaire is an 18-item scale divided into 2 subscales: function and control. The items assess how confident individuals feel that they can achieve a specific function or control various aspects of their MS. Scores are totaled on each subscale and a total MSSE is obtained. Higher scores are associated with higher degrees of certainty.

  8. Change in Quality of Life in PwMS [ Time Frame: Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks). ]
    Quality of life will be assessed in PwMS using the MS Impact Scale-29 (MSIS-29). The MSIS-29 questionnaire is a measure of physical and psychological health-related quality of life. Higher scores indicate a greater physical and psychological impact of MS on daily activities.

  9. Change in Dyadic Relationship Quality [ Time Frame: Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks) ]
    Dyadic relationship quality will be assessed both in PwMS and CGs using the Short-form Dyadic Adjustment Scale. The questionnaire consists of 7 items rated on a 5-point Likert scale. Higher scores indicate greater relationship quality.

  10. Change in Perceptions of Social Support [ Time Frame: Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks). ]
    Perceptions of social support will be assessed in both PwMS and CGs using the Interpersonal Support Evaluation List-12 (ISEL-12). This 12-item questionnaire is designed to measure 3 subscales (appraisal, belonging, and tangible) of perceived social support. Each item is rated on a 4-point scale.

  11. Change in Resilience [ Time Frame: Change in Resilience between T1 (Baseline) and T2 (12 Weeks). ]
    Resilience will be assessed in both PwMS and CGs using the Conner-Davidson Resilience Scale (CD-RISC-10). The questionnaire evaluates perceived ability to deal with stressful and challenging situations and to overcome obstacles.

  12. Change in Coping [ Time Frame: Change in Coping in CGs between T1 (Baseline) and T2 (12 Weeks). ]
    Coping will be assessed in CGs using the Coping with MS Caregiving Inventory (CMSCI). The questionnaire is a measure of 34 coping strategies specific to MS caregiving. Respondents indicate on a 4-point scale how often they have used each of the coping strategies in dealing with caregiving in general in the past month.

  13. Change in Quality of Life in Caregivers [ Time Frame: Change in Quality of life in CGs between T1 (Baseline) and T2 (12 Weeks). ]
    Quality of life in CGs will be assessed using the Caregiver Quality of Life in MS scale (CAREQOL-MS). The questionnaire is a measure of caregiver health-related quality of life. The scale consists of 24 items comprising the four subscales of physical stress/global health, social integration, emotion, and the need for assistance/emotional reactions. Items are scored using a 5-point Likert-type scale with higher scores reflecting worse quality of life.


Other Outcome Measures:
  1. Satisfaction Survey [ Time Frame: T2 (12 Weeks) ]
    All participants in the Immediate Intervention group will be asked to complete a 10-item satisfaction survey developed for this study to asses their experience of study involvement. Items are scored on a 5-point Likert scale with higher scores reflecting higher satisfaction.

  2. Experiential Aspects of Participation [ Time Frame: T2 (12 Weeks) ]
    Experiential aspects of physical activity participation will be assessed in participants in the Immediate Intervention group using the Measure of Experiential Aspects of Participation (MeEAP). The scale consists of 12 items comprising the six subscales of autonomy, belongingness, mastery, challenge, engagement, and meaning. Items are scored using a 7-point Likert-type scale with higher scores reflecting higher quality of participation.

  3. Semi-structured Qualitative Interview [ Time Frame: T2 (12 Weeks) ]
    PwMS and their CGs who complete the 12-week physical activity intervention will be asked to participate in an optional telephone qualitative interview to further explore their experiences of participating in the intervention, perceptions of benefits, and suggestions for improvement. Telephone interviews will involve participants chosen at random from those who indicated that they would be willing to be interviewed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267185


Contacts
Layout table for location contacts
Contact: Joanne Lambley, MSc (613) 562-5800 ext 3274 cepl@uottawa.ca
Contact: Afolasade Fakolade, PhD (613) 562-5800 ext 2626 cepl@uottawa.ca

Locations
Layout table for location information
Canada, Ontario
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1N 6N5
Contact: Joanne Research Coordinator    613-562-5800 ext 3274    cepl@uottawa.ca   
Contact: Afolasade Co-Principal Investigator    613-562-5800 ext 2626    cepl@uottawa.ca   
Sponsors and Collaborators
University of Ottawa
The Ottawa Hospital
Consortium of Multiple Sclerosis Centers
Investigators
Layout table for investigator information
Principal Investigator: Lara Pilutti, PhD University of Ottawa
Principal Investigator: Mark Freedman, MD The Ottawa Hospital/Ottawa Hospital Research Institute

Publications:
Layout table for additonal information
Responsible Party: Lara Pilutti, Assistant Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT04267185    
Other Study ID Numbers: 20190329-01H
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Pilutti, University of Ottawa:
Exercise
Caregiver
Physical Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases