- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175054
Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People With Multiple Sclerosis
March 16, 2023 updated by: Michelle Ploughman, Memorial University of Newfoundland
Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
New research in animal models of MS suggests that greater training intensity is required to restore lost functions.
We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate.
This study will focus on the appropriate dosage of training.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity.
As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS.
Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking.
Our second objective is to determine whether treadmill training alters indicators of brain repair.
We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up.
We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.
Study Type
Interventional
Enrollment (Anticipated)
70
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 Locations
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 1E5
- Memorial University of Newfoundland
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- people with a confirmed diagnosis of relapsing-remitting or progressive MS
- older than 18 and less than 70 years of age
- able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) <7.0)
- must be stable without relapse for at least 90 days
Exclusion Criteria:
- currently attending physical rehabilitation
- functional community ambulators (gait speed>120 cm/s)
- a relapse of MS
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Intensity Group
Less than 40% Heart Rate Reserve
|
Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision.
The high intensity group will maintain vigorous intensity with a target workload >60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (<40% heart rate reserve) for the same duration.
Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained.
The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.
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Experimental: Vigorous Intensity Group
More than 60% Heart Rate Reserve
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Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision.
The high intensity group will maintain vigorous intensity with a target workload >60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (<40% heart rate reserve) for the same duration.
Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained.
The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fast walking speed
Time Frame: 12 weeks
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Gait velocity (cm/s) measured while walking at fast pace
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatiotemporal parameters of gait measured while walking at self-selected pace
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Walkway outputs include step length and width (cm), double support time (%), symmetry (ratio between affected and less-affected sides)
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Maximal oxygen consumption during graded exercise test
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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VO2max
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Multiple Sclerosis Impact Scale-29
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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The Multiple Sclerosis Impact Scale-29 provides physical and psychological sub-scales.
Using a Likert scale, participants indicate the degree to which problems, such as 'moving about' and 'balance' affect them from 'not at all' to 'extremely'.
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Fatigue Severity Scale
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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A 9-item questionnaire, which assesses the severity of fatigue with items scored on a 7-point scale, '1 = strongly disagree' and '7 = strongly agree'.
The minimum and maximum score possible are 9 and 63 respectively.
Another reporting method is the mean of all scores from all 9-items, with minimum and maximum score possible being 1 and 7 respectively.
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Hospital Anxiety and Depression Scale
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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A self-reported rating scale of severity of mood symptoms ranging from 0-21 with higher score indicating more symptoms.
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Montreal Cognitive Assessment
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Measures overall cognitive function with score ranging from 0 to 30 with higher scores indicating higher executive function
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Symbol Digit Modality Test
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Cognitive impairment
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Transcranial Magnetic Stimulation
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Corticospinal excitability
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Serum Insulin-like growth factor-1 (IGF-1)
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Resting and exercise-induced serum levels of IGF-1 in response to the 12-week exercise intervention
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Structural and functional brain changes on Magnetic Resonance Imaging (MRI)
Time Frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Standardized protocol recommended by the Canadian Dementia Imaging Group (https://www.cdip-pcid.ca/)
which includes T1 and T2-weighted structural images, diffusion tensor imaging, and resting state connectivity.
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Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Anticipated)
November 1, 2023
Primary Completion (Anticipated)
February 1, 2025
Study Completion (Anticipated)
February 1, 2025
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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