Vigorous Cool Room Treadmill Training

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Neuronal Plasticity; Rehabilitation
• Interventions: Other: Body-weight supported treadmill training in a room cooled to 16°C

• Registration Number: NCT04066972
• Lead Sponsor: Memorial University of Newfoundland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-10
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-23
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Body-weight supported treadmill training in a room cooled to 16°C	-

Primary Outcome Measures

Name	Time	Method
Feasibility of conducting vigorous cool room treadmill training	10 weeks	Rest required (minutes)

Secondary Outcome Measures

Name	Time	Method
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
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
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
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.
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	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.
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
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	Via Accelerometry

Trial Locations

Locations (1)

Memorial University of Newfoundland; 🇨🇦 St. John's, Newfoundland and Labrador, Canada