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Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS)

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ClinicalTrials.gov Identifier: NCT04027114
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Saskatchewan Health Research Foundation (SHRF)
Saskatchewan Centre for Patient Oriented Research (SCPOR)
Information provided by (Responsible Party):
Sarah Donkers, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Individualized behavioural physical activity intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Estimated Study Start Date : July 12, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioural Physical Activity (PA) intervention Behavioral: Individualized behavioural physical activity intervention
• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.

No Intervention: Wait list control



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2) [ Time Frame: baseline to 12 months ]
    change in patient-reported disease-related symptoms measured using MSIS-29 v2 scale. MSIS-29 assess the impact of MS on health related quality of life in terms of physical and psychological well-being. The MSIS-29 v2 is a 29 item self-administered questionnaire. 20 items are associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options: 1 "not at all" to 4"extremely". Min score=29, max =116 with a higher value indicating more severely impacted

  2. Multiple Sclerosis Self Efficacy Scale (MSSE) [ Time Frame: baseline to 12 months ]
    change in patient-reported level of confidence regarding components of disease management. The MSSE has 18 items represented by two subscales of Function (9 items) and Control (9 items). Participants rate their confidence from 10-100 where 10 has an anchor of very uncertain, 50 moderately certain, and 100 very certain. A higher score meaning more confident/higher self-efficacy.

  3. Interviews and Exit surveys [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group ]
    experience of participants and interventionists

  4. Intervention Description [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group) ]
    a description of interventionist contact time with participant and frequency, method and types of services provided



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

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): NCT04027114


Locations
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Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 2Z4
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation (SHRF)
Saskatchewan Centre for Patient Oriented Research (SCPOR)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Donkers, Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04027114     History of Changes
Other Study ID Numbers: Bio-1019
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Donkers, University of Saskatchewan:
randomized controlled trial
multiple sclerosis
physiotherapy
behaviour change
physical activity
exercise
disability progression
walking function
Additional relevant MeSH terms:
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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