Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— IPAC-MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027114
• Other study ID #: Bio-1019
• Status: Completed
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: November 2021
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 21, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation (SHRF)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)