Exercise Effects in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis

Intervention / Treatment
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* Other: Exercise Group 1
* Other: Exercise Group 2
* Other: Exercise Group 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group 1<br>The intervention will focus on mobility and balance. | Other: Exercise Group 1<br>* Prescribed exercises will focus on mobility and balance.<br>|
| Active Comparator: Exercise Group 2<br>This intervention will focus on physical fitness. | Other: Exercise Group 2<br>* Prescribed exercises will focus on physical fitness.<br>|
| Sham Comparator: Exercise Group 3<br>This intervention will focus on flexibility, range of motion, and muscle tone. | Other: Exercise Group 3<br>* Prescribed exercises will focus on flexibility, range of motion, and muscle tone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25-Foot Walk Test | The Timed 25-Foot Walk Test provides an assessment of mobility and lower-extremity function through a measurement of fast walking speed. Test scores range from 0-180 seconds with higher values indicating a worse outcome. | 6 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Evoked Potential Amplitude | Measuring the amplitude of motor evoked potentials elicited by transcranial magnetic stimulation delivered over the motor cortex provides information about corticospinal excitability. Corticospinal excitability is a potential marker of MS disease burden that is responsive to physical training in people with MS and has been used to study experience-dependent neuroplasticity in other neurological conditions. The range of response amplitude is 0-100% of maximal muscle fibre recruitment, with higher values indicating better outcome. | 6 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Central Nervous System, Motor Learning, Transcranial Magnetic Stimulation, Mobility Limitation