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Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People With Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04175054
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial University of Newfoundland
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michelle Ploughman, PhD
Principal Investigator Affiliation	Memorial University of Newfoundland
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Neurological Rehabilitation, Exercise, Neuronal Plasticity, Cooling

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Low Intensity Group

Less than 40% Heart Rate Reserve

Experimental: Vigorous Intensity Group

More than 60% Heart Rate Reserve

Interventions

Other: - Body-weight supported treadmill training in a room cooled to 16°C

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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If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada

Status

Address

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1A 1E5

Site Contact

[email protected]

709-777-2099

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