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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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.
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
Fast walking speed
Gait velocity (cm/s) measured while walking at fast pace
Time frame: 12 weeks
Spatiotemporal parameters of gait measured while walking at self-selected pace
Walkway outputs include step length and width (cm), double support time (%), symmetry (ratio between affected and less-affected sides)
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Maximal oxygen consumption during graded exercise test
VO2max
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Multiple Sclerosis Impact Scale-29
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'.
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Fatigue Severity Scale
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.
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Hospital Anxiety and Depression Scale
A self-reported rating scale of severity of mood symptoms ranging from 0-21 with higher score indicating more symptoms.
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Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Montreal Cognitive Assessment
Measures overall cognitive function with score ranging from 0 to 30 with higher scores indicating higher executive function
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Symbol Digit Modality Test
Cognitive impairment
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Transcranial Magnetic Stimulation
Corticospinal excitability
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Serum Insulin-like growth factor-1 (IGF-1)
Resting and exercise-induced serum levels of IGF-1 in response to the 12-week exercise intervention
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Structural and functional brain changes on Magnetic Resonance Imaging (MRI)
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.
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention