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Exercise Effects in Multiple Sclerosis

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Group 1
Exercise Group 2
Exercise Group 3
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis, Primary Progressive focused on measuring Progressive Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Central Nervous System, Motor Learning, Transcranial Magnetic Stimulation, Mobility Limitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of progressive MS by a neurologist
  • physician clearance for exercise
  • a Patient-Determined Disease Steps (PDSS) score between 2 and 6 (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

Sites / Locations

  • University of ReginaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Exercise Group 1

Exercise Group 2

Exercise Group 3

Arm Description

The intervention will focus on mobility and balance.

This intervention will focus on physical fitness.

This intervention will focus on flexibility, range of motion, and muscle tone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 14, 2022
Last Updated
July 28, 2023
Sponsor
University of Regina
Collaborators
First Steps Wellness Centre, Saskatchewan Health Research Foundation, University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT05496881
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
First Steps Wellness Centre, Saskatchewan Health Research Foundation, University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group 1
Arm Type
Experimental
Arm Description
The intervention will focus on mobility and balance.
Arm Title
Exercise Group 2
Arm Type
Active Comparator
Arm Description
This intervention will focus on physical fitness.
Arm Title
Exercise Group 3
Arm Type
Sham Comparator
Arm Description
This intervention will focus on flexibility, range of motion, and muscle tone.
Intervention Type
Other
Intervention Name(s)
Exercise Group 1
Intervention Description
Prescribed exercises will focus on mobility and balance.
Intervention Type
Other
Intervention Name(s)
Exercise Group 2
Intervention Description
Prescribed exercises will focus on physical fitness.
Intervention Type
Other
Intervention Name(s)
Exercise Group 3
Intervention Description
Prescribed exercises will focus on flexibility, range of motion, and muscle tone.
Primary Outcome Measure Information:
Title
Timed 25-Foot Walk Test
Description
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.
Time Frame
6 weeks post intervention
Secondary Outcome Measure Information:
Title
Motor Evoked Potential Amplitude
Description
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.
Time Frame
6 weeks post intervention
Other Pre-specified Outcome Measures:
Title
Mini Balance Evaluation Systems Test
Description
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.
Time Frame
6 weeks post intervention
Title
Multiple Sclerosis Impact Scale
Description
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.
Time Frame
6 weeks post intervention
Title
9-Hole Pegboard Test
Description
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.
Time Frame
6 weeks post intervention
Title
Symbol Digit Modalities Test
Description
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.
Time Frame
6 weeks post intervention
Title
Peak Isometric Hand Grip Force
Description
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.
Time Frame
6 weeks post intervention
Title
Peak Isometric Knee Extensor Torque
Description
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.
Time Frame
6 weeks post intervention
Title
Peak Oxygen Uptake
Description
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.
Time Frame
6 weeks post intervention
Title
Tumor Necrosis Factor Alpha concentration in systemic blood
Description
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.
Time Frame
6 weeks post intervention
Title
Brain-Derived Neurotrophic Factor in systemic blood
Description
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.
Time Frame
6 weeks post intervention
Title
Neurofilament Light concentration in systemic blood
Description
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.
Time Frame
6 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cameron Mang, PhD
Phone
306-585-4066
Email
cameron.mang@uregina.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Mang, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S5N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron S Mang, PhD
Phone
3065854066
Email
cameron.mang@uregina.ca
First Name & Middle Initial & Last Name & Degree
G

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers.
Citations:
PubMed Identifier
21172683
Citation
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Results Reference
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Results Reference
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24174581
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Exercise Effects in Multiple Sclerosis

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