Vigorous Cool Room Treadmill Training

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066972
• Other study ID #: 2018.088
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Neuronal Plasticity
• Rehabilitation

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