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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Individualized behavioural physical activity intervention

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 2Z4
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Wait list control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)	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	baseline to 12 months
Multiple Sclerosis Self Efficacy Scale (MSSE)	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.	baseline to 12 months
Interviews and Exit surveys	experience of participants and interventionists	after intervention (at 12 month point for intervention group and 18 month for wait-list control) group
Intervention Description	a description of interventionist contact time with participant and frequency, method and types of services provided	after intervention (at 12 month point for intervention group and 18 month for wait-list control group)

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Centre for Patient-Oriented Research; Saskatchewan Health Research Foundation (SHRF)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2019
• Primary Completion (ACTUAL): January 15, 2021
• Study Completion (ACTUAL): June 21, 2021

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; randomized controlled trial; exercise; multiple sclerosis; physiotherapy; walking function; behaviour change; disability progression
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Bio-1019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No