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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body-weight supported treadmill training in a room cooled to 16°C | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial University of Newfoundland | St. John's | Newfoundland and Labrador | A1A 1E5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32168157 | Derived | Chaves AR, Devasahayam AJ, Kelly LP, Pretty RW, Ploughman M. Exercise-Induced Brain Excitability Changes in Progressive Multiple Sclerosis: A Pilot Study. J Neurol Phys Ther. 2020 Apr;44(2):132-144. doi: 10.1097/NPT.0000000000000308. | |
| 31969132 | Derived | Devasahayam AJ, Chaves AR, Lasisi WO, Curtis ME, Wadden KP, Kelly LP, Pretty R, Chen A, Wallack EM, Newell CJ, Williams JB, Kenny H, Downer MB, McCarthy J, Moore CS, Ploughman M. Vigorous cool room treadmill training to improve walking ability in people with multiple sclerosis who use ambulatory assistive devices: a feasibility study. BMC Neurol. 2020 Jan 22;20(1):33. doi: 10.1186/s12883-020-1611-0. |
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The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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This is a 'proof-of-principle/feasibility' within group repeated measures study.
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |