Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People with Multiple Sclerosis
- Conditions
- Multiple SclerosisExerciseNeurological RehabilitationNeuronal PlasticityCooling
- Interventions
- Other: Body-weight supported treadmill training in a room cooled to 16°C
- Registration Number
- NCT04175054
- Lead Sponsor
- Memorial University of Newfoundland
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 70
- 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
- currently attending physical rehabilitation
- functional community ambulators (gait speed>120 cm/s)
- a relapse of MS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vigorous Intensity Group Body-weight supported treadmill training in a room cooled to 16°C More than 60% Heart Rate Reserve Low Intensity Group Body-weight supported treadmill training in a room cooled to 16°C Less than 40% Heart Rate Reserve
- Primary Outcome Measures
Name Time Method Fast walking speed 12 weeks Gait velocity (cm/s) measured while walking at fast pace
- Secondary Outcome Measures
Name Time Method Spatiotemporal parameters of gait measured while walking at self-selected pace Following completion of the 12-week exercise intervention and 3-months post-exercise intervention Walkway outputs include step length and width (cm), double support time (%), symmetry (ratio between affected and less-affected sides)
Maximal oxygen consumption during graded exercise test Following completion of the 12-week exercise intervention and 3-months post-exercise intervention VO2max
Multiple Sclerosis Impact Scale-29 Following completion of the 12-week exercise intervention and 3-months post-exercise intervention 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'.
Hospital Anxiety and Depression Scale Following completion of the 12-week exercise intervention and 3-months post-exercise intervention A self-reported rating scale of severity of mood symptoms ranging from 0-21 with higher score indicating more symptoms.
Fatigue Severity Scale Following completion of the 12-week exercise intervention and 3-months post-exercise intervention 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.
Symbol Digit Modality Test Following completion of the 12-week exercise intervention and 3-months post-exercise intervention Cognitive impairment
Serum Insulin-like growth factor-1 (IGF-1) Following completion of the 12-week exercise intervention and 3-months post-exercise intervention Resting and exercise-induced serum levels of IGF-1 in response to the 12-week exercise intervention
Transcranial Magnetic Stimulation Following completion of the 12-week exercise intervention and 3-months post-exercise intervention Corticospinal excitability
Structural and functional brain changes on Magnetic Resonance Imaging (MRI) Following completion of the 12-week exercise intervention and 3-months post-exercise intervention 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.
Montreal Cognitive Assessment Following completion of the 12-week exercise intervention and 3-months post-exercise intervention Measures overall cognitive function with score ranging from 0 to 30 with higher scores indicating higher executive function
Trial Locations
- Locations (1)
Memorial University of Newfoundland
🇨🇦St. John's, Newfoundland and Labrador, Canada