Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
More Inclusion & Exclusion 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Ottawa|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Lara Pilutti, PhDMark Freedman, MD|
|Principal Investigator Affiliation||University of OttawaThe Ottawa Hospital/Ottawa Hospital Research Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms & Interventions
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.
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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.