Clinical trial NCT04066972: Vigorous Cool Room Treadmill Training
Official title: Intensive Aerobic and Task-specific Training to Restore Walking and Boost Neuroplasticity Among People With MS-related Walking Disability: a Proof of Principle Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Rehabilitation
Gait Disorders, Neurologic
Neuronal Plasticity
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a 'proof-of-principle/feasibility' within group repeated measures study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of conducting vigorous cool room treadmill training
timeFrame: 10 weeks
measure: Feasibility of conducting vigorous cool room treadmill training
timeFrame: 10 weeks
measure: Feasibility of conducting vigorous cool room treadmill training
timeFrame: 10 weeks
measure: Feasibility of conducting vigorous cool room treadmill training
timeFrame: 10 weeks
Secondary outcomes:
measure: Timed 25 foot walk test
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Spatiotemporal parameters of gait measured while walking at fast and self-selected pace
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Fatigue severity scale
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Modified fatigue impact scale
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Maximal oxygen consumption during graded exercise test
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Health-related quality of life assessed using 36-Item Short-Form Health Survey
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Serum brain derived neurotrophic factor
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Serum interleukin-6
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Montreal cognitive assessment
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Corticospinal excitability measured using transcranial magnetic stimulation
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Body composition measured using dual energy x-ray absorptiometry
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Magnetization transfer ratio measured using magnetic resonance imaging
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Aerobic cost of walking
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
measure: Step counts
timeFrame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
References:
citation: 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.
citation: 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.