Multiple SclerosisPAT-MSNCT04267185
A Dyadic Approach for Promoting Physical Activity Among People with MS and Their Support Partners
A study testing Physical Activity Together for PwMS and their CGs (PAT-MS) in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical Activity Together for PwMS and their CGs (PAT-MS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 4 Feb 2020to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- diagnosis of other neurological condition(s)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical Activity Together for PwMS and their CGs (PAT-MS)
- Keywords
- Exercise, Caregiver, Physical Activity
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Together for PwMS and their CGs (PAT-MS)Behavioural
A dyadic physical activity intervention approach for PwMS and their family CGs affected by moderate-to-severe MS disability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Will be assessed at T2 (12 Weeks)
Feasibility: Monetary cost of research
We will establish and record all monetary costs for the study.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks).
Change in Accelerometer-measured Physical Activity - minutes of PA
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.
Measured: Change in accelerometer-measured minutes of PA between T1 (Baseline) and T2 (12 Weeks).
Change in Walking Speed
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.
Measured: Change in walking speed between T1 (Baseline) and T2 (12 Weeks).
Change in Walking Endurance
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.
Measured: Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks)
Change in Agility
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.
Measured: Change in Agility between T1 (Baseline) and T2 (12 Weeks).
Change in Physical Functional Limitations and Disability
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.
Measured: Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks).
Change in MS Self-Efficacy
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.
Measured: Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks).
Change in Quality of Life in PwMS
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.
Measured: Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks).
Change in Dyadic Relationship Quality
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.
Measured: Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks)
Change in Perceptions of Social Support
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.
Measured: Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks).
Change in Resilience
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.
Measured: Change in Resilience between T1 (Baseline) and T2 (12 Weeks).
Change in Coping
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.
Measured: Change in Coping in CGs between T1 (Baseline) and T2 (12 Weeks).
Change in Quality of Life in Caregivers
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.
Measured: Change in Quality of life in CGs between T1 (Baseline) and T2 (12 Weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start4 Feb 2020
- Primary completion12 Jun 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, Consortium of Multiple Sclerosis Centers, Queen's University
- Responsible party
- Principal investigator, Lara Pilutti, University of Ottawa
- Investigators
- Lara Pilutti, PhD, Principal investigator, University of OttawaMark Freedman, MD, Principal investigator, The Ottawa Hospital/Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267185
- Sponsor's protocol ID
- 20190329-01H
- Acronym
- PAT-MS
- Status last verified
- May 2023
- First submitted
- 16 Jan 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28722772Fakolade 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.
PubMed 29958014Fakolade 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.
PubMed 30745723Fakolade 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.
PubMed 37928934Fakolade 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.
PubMed 34061040
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04267185
- Acronym / sponsor ID
- PAT-MS / 20190329-01H
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Caregiver, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, Consortium of Multiple Sclerosis Centers, Queen's University
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Physical Activity Together for PwMS and their CGs (PAT-MS)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- diagnosis of other neurological condition(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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
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
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.
13 secondary outcomes
Change in Accelerometer-measured Physical Activity - steps/day
Time frame: Change in accelerometer-measured steps/day between T1 (Baseline) and T2 (12 Weeks).
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).
Change in Walking Speed
Time frame: Change in walking speed between T1 (Baseline) and T2 (12 Weeks).
Change in Walking Endurance
Time frame: Change in Walking endurance between T1 (Baseline) and T2 (12 Weeks)
Change in Agility
Time frame: Change in Agility between T1 (Baseline) and T2 (12 Weeks).
Change in Physical Functional Limitations and Disability
Time frame: Change in Physical functional limitations and disability between T1 (Baseline) and T2 (12 Weeks).
Change in MS Self-Efficacy
Time frame: Change in MS self-efficacy between T1 (Baseline) and T2 (12 Weeks).
Change in Quality of Life in PwMS
Time frame: Change in Quality of life in PwMS between T1 (Baseline) and T2 (12 Weeks).
Change in Dyadic Relationship Quality
Time frame: Change in Dyadic relationship quality between T1 (Baseline) and T2 (12 Weeks)
Change in Perceptions of Social Support
Time frame: Change in perceptions of social support between T1 (Baseline) and T2 (12 Weeks).
Change in Resilience
Time frame: Change in Resilience between T1 (Baseline) and T2 (12 Weeks).
Change in Coping
Time frame: Change in Coping in CGs between T1 (Baseline) and T2 (12 Weeks).
Change in Quality of Life in Caregivers
Time frame: Change in Quality of life in CGs between T1 (Baseline) and T2 (12 Weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 28722772Fakolade 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.
- Background: PubMed 29958014Fakolade 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.
- Background: PubMed 30745723Fakolade 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.
- Derived from this study: PubMed 37928934Fakolade 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.
- Derived from this study: PubMed 34061040Fakolade 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Pilutti, PhD principal investigator
University of Ottawa
Mark Freedman, MD principal investigator
The Ottawa Hospital/Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Together for PwMS and their CGs (PAT-MS) in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the PAT-MS intervention (time frame: Assessed weekly through study completion at 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267185, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.