Gait Disorders, Neurologic, Multiple Sclerosis, Neuronal Plasticity, Rehabilitation
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Memorial University of Newfoundland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a 'proof-of-principle/feasibility' within group repeated measures study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of conducting vigorous cool room treadmill training | 10 weeks | Recruitment and retention rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Following completion of the 10-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. |
| Modified fatigue impact scale | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | 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. |
| 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 | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | Resting and exercise-induced serum levels of brain derived neurotrophic factor in response to the 10-week exercise intervention |
| Timed 25 foot walk test | 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 | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | Via Accelerometry |
| Serum interleukin-6 | Following completion of the 10-week exercise intervention and 3-months post-exercise intervention | Resting and exercise-induced serum levels of interleukin-6 in response to the 10-week exercise intervention |
Countries
Canada
Outcome results
None listed