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Clinical Trials/NCT04027114
NCT04027114
Completed
Not Applicable

Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial

University of Saskatchewan1 site in 1 country120 target enrollmentJuly 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Saskatchewan
Enrollment
120
Locations
1
Primary Endpoint
Godin Leisure Time Exercise Questionnaire (GLTEQ) Score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.

Registry
clinicaltrials.gov
Start Date
July 12, 2019
End Date
June 21, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Donkers

Assistant Professor

University of Saskatchewan

Eligibility Criteria

Inclusion Criteria

  • clinically definite MS (diagnosed by a neurologist)
  • patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
  • GLTEQ\<24 (not active enough for health benefits)

Exclusion Criteria

  • medical instability (PAR-Q moderate-high risk of exercise-related harm)
  • persons unable to provide consent
  • persons under the age of 18 years old

Outcomes

Primary Outcomes

Godin Leisure Time Exercise Questionnaire (GLTEQ) Score

Time Frame: baseline to 12 months

change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.

Secondary Outcomes

  • Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)(baseline to 12 months)
  • Multiple Sclerosis Self Efficacy Scale (MSSE)(baseline to 12 months)
  • Interviews and Exit surveys(after intervention (at 12 month point for intervention group and 18 month for wait-list control) group)
  • Intervention Description(after intervention (at 12 month point for intervention group and 18 month for wait-list control group))

Study Sites (1)

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