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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04066972
Other study ID # 2018.088
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2018
Est. completion date July 9, 2019

Study information

Verified date August 2019
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 9, 2019
Est. primary completion date July 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Other:
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 (16° 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.

Locations

Country Name City State
Canada Memorial University of Newfoundland St. John's Newfoundland and Labrador

Sponsors (1)

Lead Sponsor Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of conducting vigorous cool room treadmill training Recruitment and retention rates 10 weeks
Primary Feasibility of conducting vigorous cool room treadmill training Incidence of adverse events 10 weeks
Primary Feasibility of conducting vigorous cool room treadmill training Degree of body-weight support provided by the harness (%) 10 weeks
Primary Feasibility of conducting vigorous cool room treadmill training Rest required (minutes) 10 weeks
Secondary Timed 25 foot walk test Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary 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
Secondary 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
Secondary 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
Secondary Maximal oxygen consumption during graded exercise test Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary 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
Secondary 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
Secondary 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
Secondary Montreal cognitive assessment Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary Corticospinal excitability measured using transcranial magnetic stimulation Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary Body composition measured using dual energy x-ray absorptiometry Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary Magnetization transfer ratio measured using magnetic resonance imaging Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary Aerobic cost of walking Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Secondary Step counts Via Accelerometry Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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