Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis

NCT04027114 | Completed

• 1 other identifier: Bio-1019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

randomized controlled trial; multiple sclerosis; physiotherapy; behaviour change; physical activity; exercise; disability progression; walking function

Outcome Measures

Primary Outcomes (1)

• Godin Leisure Time Exercise Questionnaire (GLTEQ) Score

  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.

  baseline to 12 months

Secondary Outcomes (4)

• 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 Arms (2)

Behavioural Physical Activity (PA) intervention

EXPERIMENTAL

Behavioral: Individualized behavioural physical activity intervention

Wait list control

NO INTERVENTION

Interventions

Individualized behavioural physical activity intervention BEHAVIORAL

• 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.

Behavioural Physical Activity (PA) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation (SHRF): collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 2Z4, Canada

Location

Related Publications (2)

• Donkers SJ, Evans C, Levin MC, Ives K, Le H, Lim HJ, Knox KB. Individualized Physiotherapy and Activity Coaching in Multiple Sclerosis (IPAC-MS): Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Aug;106(8):1145-1154. doi: 10.1016/j.apmr.2025.02.005. Epub 2025 Feb 15.

  PMID: 39961428 DERIVED

• Goulding FL, Evans CD, Knox KB, Lim HJ, Levin MC, Donkers SJ. Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):664. doi: 10.1186/s13063-019-3768-7.

  PMID: 31791380 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 19, 2019
• Study Start: July 12, 2019
• Primary Completion: January 15, 2021
• Study Completion: June 21, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

CA (1)