Clinical trial NCT05496881: Exercise Effects in Multiple Sclerosis
Official title: Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Keywords: Progressive Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Central Nervous System
Motor Learning
Transcranial Magnetic Stimulation
Mobility Limitation
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: First Steps Wellness Centre
name: Saskatchewan Health Research Foundation
name: University of Saskatchewan
First posted: 2022-08-11
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All interventions will involve 60-minute sessions delivered three times per week for 12 weeks. All interventions will involve the whole body but differ in content.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people with MS.

Detailed description: A total of 69 participants with multiple sclerosis (MS) and moderate motor disability in the province of Saskatchewan, Canada will be randomly assigned to receive one of three distinct exercise programs. All exercise programs will be delivered three times per week in 60-minute group sessions over the course of 12 weeks under the supervision of Clinical Exercise Physiologists. Exercise programming will include activities focused on mobility, fitness, and flexibility. Assessments of physical function, physical fitness, and central nervous system function will be conducted immediately before, after, and six weeks following completion of the exercise programs.

Eligibility criteria: Inclusion Criteria:

* diagnosis of progressive MS by a neurologist
* physician clearance for exercise
* a Patient-Determined Disease Steps (PDSS) score between 3 and 7 (i.e., moderate motor disability)
* a Timed 25-Foot Walk (T25-FW) test time \> 6.0 s.

Exclusion Criteria:

* a baseline score \>24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)
* absolute contraindications to TMS (e.g. history of seizure)
* a history of any neurological conditions other than MS
* relapse in the past three months (self-reported, neurologist confirmed)
* psychiatric diagnosis
* substance abuse

Primary outcomes:
measure: Timed 25-Foot Walk Test
timeFrame: 6 weeks post intervention
Secondary outcomes:
measure: Motor Evoked Potential Amplitude
timeFrame: 6 weeks post intervention
Other outcomes:
measure: Mini Balance Evaluation Systems Test
timeFrame: 6 weeks post intervention
measure: Multiple Sclerosis Impact Scale
timeFrame: 6 weeks post intervention
measure: 9-Hole Pegboard Test
timeFrame: 6 weeks post intervention
measure: Symbol Digit Modalities Test
timeFrame: 6 weeks post intervention
measure: Peak Isometric Hand Grip Force
timeFrame: 6 weeks post intervention
measure: Peak Isometric Knee Extensor Torque
timeFrame: 6 weeks post intervention
measure: Peak Oxygen Uptake
timeFrame: 6 weeks post intervention
measure: Tumor Necrosis Factor Alpha concentration in systemic blood
timeFrame: 6 weeks post intervention
measure: Brain-Derived Neurotrophic Factor in systemic blood
timeFrame: 6 weeks post intervention
measure: Neurofilament Light concentration in systemic blood
timeFrame: 6 weeks post intervention
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Cameron Mang, PhD
role: PRINCIPAL_INVESTIGATOR
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