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Exercise Effects in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05496881
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : February 15, 2024
Sponsor:
Collaborators:
First Steps Wellness Centre
Saskatchewan Health Research Foundation
University of Saskatchewan
Information provided by (Responsible Party):
University of Regina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Chronic Progressive Multiple Sclerosis Other: Exercise Group 1 Other: Exercise Group 2 Other: Exercise Group 3 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants will not be informed of the different study arms. Interventions will be scheduled to avoid contact between study arms. Participants will be asked to not describe their activities to those outside of their exercise group. Although it will not be possible to blind program instructors from the intervention that they deliver, instructors will not be aware of the expected results. Assessors and data analysts will be fully blinded to study arm allocation.
Primary Purpose: Supportive Care
Official Title: Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05496881


Contacts
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Contact: Cameron Mang, PhD 306-585-4066 cameron.mang@uregina.ca

Locations
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Canada, Saskatchewan
University of Regina Recruiting
Regina, Saskatchewan, Canada, S4S5N6
Contact: Cameron S Mang, PhD    3065854066    cameron.mang@uregina.ca   
Contact: G         
Sponsors and Collaborators
University of Regina
First Steps Wellness Centre
Saskatchewan Health Research Foundation
University of Saskatchewan
Investigators
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Principal Investigator: Cameron Mang, PhD University of Regina
More Information
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Publications:

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Responsible Party: University of Regina
ClinicalTrials.gov Identifier: NCT05496881    
Other Study ID Numbers: 2021-197
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Regina:
Progressive Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Central Nervous System
 Motor Learning
Transcranial Magnetic Stimulation
Mobility Limitation
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes