Vigorous Cool Room Treadmill Training

Study Overview
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Brief Summary
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People with multiple sclerosis (MS) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. We have developed a cool room treadmill training method that uses body-weight support that people with MS fatigue and heat sensitivity can tolerate. Our previous research shows that people with advanced MS use three times more energy for essential tasks such as walking. This project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking, fitness and fatigue in people with advanced MS.

Official Title
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Intensive Aerobic and Task-specific Training to Restore Walking and Boost Neuroplasticity Among People With MS-related Walking Disability: a Proof of Principle Trial

Conditions
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Multiple Sclerosis, Rehabilitation, Gait Disorders, Neurologic, Neuronal Plasticity

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically definite MS relapse-free in the previous 3 months requiring ambulatory assistive devices (EDSS 6.0-7.0) negative PAR-Q screen for risk factors greater than 6-weeks post Botulinum Toxin injection (if received) in the lower extremity Exclusion Criteria: pregnancy or intention of becoming pregnant finished a drug/device study in the last 30 days over 75 years of age unable to control bowel and bladder on physical exertion currently attending physical rehabilitation having no difficulty walking in the community (self-selected walking speed >120 cm/s)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a 'proof-of-principle/feasibility' within group repeated measures study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Other: Body-weight supported treadmill training in a room cooled to 16°C<br>* A total of 30 training sessions will be conducted in 10 weeks for 30 minutes per session and 3 times per week in a cool room (16⁰ C) on a treadmill that is equipped with safety straps to prevent falls. A pneumatic harness system will be used to provide 10% body-weight support during training sessions. The participants will start exercising on the treadmill at 80% of their self-selected walking speed with 1% incline and will increase as per their tolerance (will progress weekly based on 40-65% heart rate reserve). Heart rate, perceived fatigue and rating of perceived exertion will be monitored continuously during exercise sessions. Initial training will commence with intermittent rest periods [1 to 5 minutes] as requested by the participants and will be progressed to a maximum of 30-minute continuous treadmill walking.<br>* Other names: Vigorous cool room treadmill training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of conducting vigorous cool room treadmill training | Recruitment and retention rates | 10 weeks | 
| Feasibility of conducting vigorous cool room treadmill training | Incidence of adverse events | 10 weeks | 
| Feasibility of conducting vigorous cool room treadmill training | Degree of body-weight support provided by the harness (%) | 10 weeks | 
| Feasibility of conducting vigorous cool room treadmill training | Rest required (minutes) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25 foot walk test |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Spatiotemporal parameters of gait measured while walking at fast and self-selected pace |  | Following completion of the 10-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. | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Modified fatigue impact scale | A 21-item scale, which assesses the perceived impact of fatigue with items rated by participants on a 5-point Likert scale, '0 = never' to '4 = almost always'. The items are aggregated into total score as well as three subscales: physical, cognitive, and psychosocial. The total score ranges from 0 to 84, physical subscale from 0 to 36, cognitive subscale from 0 to 40, and psychosocial subscale from 0 to 8. | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Maximal oxygen consumption during graded exercise test |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Health-related quality of life assessed using 36-Item Short-Form Health Survey |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Serum brain derived neurotrophic factor | Resting and exercise-induced serum levels of brain derived neurotrophic factor in response to the 10-week exercise intervention | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Serum interleukin-6 | Resting and exercise-induced serum levels of interleukin-6 in response to the 10-week exercise intervention | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Montreal cognitive assessment |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Corticospinal excitability measured using transcranial magnetic stimulation |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Body composition measured using dual energy x-ray absorptiometry |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Magnetization transfer ratio measured using magnetic resonance imaging |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Aerobic cost of walking |  | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 
| Step counts | Via Accelerometry | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention |