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

Memorial University of Newfoundland1 site in 1 country10 target enrollmentJuly 10, 2018

ConditionsMultiple Sclerosis Rehabilitation Gait Disorders, Neurologic Neuronal Plasticity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Memorial University of Newfoundland
Enrollment: 10
Locations: 1
Primary Endpoint: Feasibility of conducting vigorous cool room treadmill training
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 10, 2018

End Date

July 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial University of Newfoundland

Responsible Party

Principal Investigator

Michelle Ploughman

Assistant Professor of Medicine

Memorial University of Newfoundland

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)

Outcomes

Primary Outcomes

Feasibility of conducting vigorous cool room treadmill training

Time Frame: 10 weeks

Rest required (minutes)

Secondary Outcomes

Timed 25 foot walk test(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 interleukin-6(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(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)
Modified fatigue impact scale(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)
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)
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)