Exercise Effects in Multiple Sclerosis

February 14, 2024 updated by: University of Regina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S5N6
        • Recruiting
        • University of Regina
        • Contact:
          • G
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 25-Foot Walk Test
Time Frame: 6 weeks post intervention
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
Time Frame: 6 weeks post intervention
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Balance Evaluation Systems Test
Time Frame: 6 weeks post intervention
The Mini Balance Evaluation Systems Test provides an assessment of balance control systems. The Mini-BESTest has a high sensitivity in detecting balance impairments in people with MS. The Mini-BESTest has score values between 0-28 with a higher score meaning a better outcome.
6 weeks post intervention
Multiple Sclerosis Impact Scale
Time Frame: 6 weeks post intervention
The Multiple Sclerosis Impact Scale is a self-report survey that measures the impact of multiple sclerosis on physical and psychological functioning. The MSIS test has a score value between 0-145 with a higher score meaning a worse outcome.
6 weeks post intervention
9-Hole Pegboard Test
Time Frame: 6 weeks post intervention
The 9-Hole Pegboard Test is a quantitative measure of upper extremity function. The test has a time limit of 300 seconds with higher values indicating a worse outcome.
6 weeks post intervention
Symbol Digit Modalities Test
Time Frame: 6 weeks post intervention
The Symbol Digit Modalities Test is used to asses divided attention, visual scanning, tracking and motor speed. The SDMT test is scored as the number of correct answers provided within 90 seconds (range: 0-110). A higher score would indicate a better outcome.
6 weeks post intervention
Peak Isometric Hand Grip Force
Time Frame: 6 weeks post intervention
Peak Isometric Hand Grip Force provides a measure of general upper-extremity strength. Values typically range from 0 to approximately 75 kilograms of force, with higher values indicating greater strength.
6 weeks post intervention
Peak Isometric Knee Extensor Torque
Time Frame: 6 weeks post intervention
Peak Isometric Knee Extensor Torque provides a measure of general lower-extremity strength. Values typically range from 0 to approximately 75 kg of force, with higher values indicating greater strength. Values typically range from 0 to approximately 300 Newton*Meters of torque, with higher values indicating greater strength.
6 weeks post intervention
Peak Oxygen Uptake
Time Frame: 6 weeks post intervention
Peak Oxygen Uptake provides a measure of cardiorespiratory fitness. It is measured through administration of a maximal exercise test. Values typically range from 0-90 milliliters per minute per kilogram.
6 weeks post intervention
Tumor Necrosis Factor Alpha concentration in systemic blood
Time Frame: 6 weeks post intervention
Tumor Necrosis Factor is an inflammatory cytokine that can be measured in human blood serum. Values typically range from 100 to 5000 picograms per milliliter of blood serum. Higher values are generally considered worse.
6 weeks post intervention
Brain-Derived Neurotrophic Factor in systemic blood
Time Frame: 6 weeks post intervention
Brain-Derived Neurotrophic Factor is a neurotrophic growth factor that can be measured in human blood serum. Values typically range from 15 to 80 nanograms per milliliter of blood serum. Higher values are generally considered better.
6 weeks post intervention
Neurofilament Light concentration in systemic blood
Time Frame: 6 weeks post intervention
Neurofilament Light is a neuronal cytoplasmic protein that can be measured in human blood serum. Values typically range from 0 to 100 picograms per milliliter of blood serum. Higher values are generally considered worse.
6 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regina

Collaborators

University of Saskatchewan
Saskatchewan Health Research Foundation
First Steps Wellness Centre

Investigators

  • Principal Investigator: Cameron Mang, PhD, University of Regina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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