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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Individualized behavioural physical activity intervention
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring randomized controlled trial, multiple sclerosis, physiotherapy, behaviour change, physical activity, exercise, disability progression, walking function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioural Physical Activity (PA) intervention

Wait list control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Interviews and Exit surveys
experience of participants and interventionists
Intervention Description
a description of interventionist contact time with participant and frequency, method and types of services provided

Full Information

First Posted
July 10, 2019
Last Updated
November 28, 2021
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation (SHRF), Saskatchewan Centre for Patient-Oriented Research
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1. Study Identification

Unique Protocol Identification Number
NCT04027114
Brief Title
Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis
Acronym
IPAC-MS
Official Title
Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation (SHRF), Saskatchewan Centre for Patient-Oriented Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
randomized controlled trial, multiple sclerosis, physiotherapy, behaviour change, physical activity, exercise, disability progression, walking function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioural Physical Activity (PA) intervention
Arm Type
Experimental
Arm Title
Wait list control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Individualized behavioural physical activity intervention
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
Godin Leisure Time Exercise Questionnaire (GLTEQ) Score
Description
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.
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)
Description
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
Time Frame
baseline to 12 months
Title
Multiple Sclerosis Self Efficacy Scale (MSSE)
Description
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.
Time Frame
baseline to 12 months
Title
Interviews and Exit surveys
Description
experience of participants and interventionists
Time Frame
after intervention (at 12 month point for intervention group and 18 month for wait-list control) group
Title
Intervention Description
Description
a description of interventionist contact time with participant and frequency, method and types of services provided
Time Frame
after intervention (at 12 month point for intervention group and 18 month for wait-list control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 2Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31791380
Citation
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.
Results Reference
derived

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Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis

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