Vigorous Cool Room Treadmill Training

NCT ID: NCT04066972

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2019-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis Rehabilitation Gait Disorders, Neurologic Neuronal Plasticity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a 'proof-of-principle/feasibility' within group repeated measures study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

Body-weight supported treadmill training in a room cooled to 16°C

Intervention Type 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.

Interventions

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Body-weight supported treadmill training in a room cooled to 16°C

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.

Intervention Type OTHER

Other Intervention Names

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Vigorous cool room treadmill training

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Michelle Ploughman

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32168157 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31969132 (View on PubMed)

Other Identifiers

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2018.088

Identifier Type: -

Identifier Source: org_study_id

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