Clinical trial NCT04027114: Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis
Official title: Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: randomized controlled trial
multiple sclerosis
physiotherapy
behaviour change
physical activity
exercise
disability progression
walking function
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation (SHRF)
name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2019-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Godin Leisure Time Exercise Questionnaire (GLTEQ) Score
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)
timeFrame: baseline to 12 months
measure: Multiple Sclerosis Self Efficacy Scale (MSSE)
timeFrame: baseline to 12 months
measure: Interviews and Exit surveys
timeFrame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group
measure: Intervention Description
timeFrame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group)
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
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.