Vigorous Cool Room Treadmill Training
Primary Purpose
Multiple Sclerosis, Rehabilitation, Gait Disorders, Neurologic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Body-weight supported treadmill training in a room cooled to 16°C
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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)
Sites / Locations
- Memorial University of Newfoundland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of conducting vigorous cool room treadmill training
Recruitment and retention rates
Feasibility of conducting vigorous cool room treadmill training
Incidence of adverse events
Feasibility of conducting vigorous cool room treadmill training
Degree of body-weight support provided by the harness (%)
Feasibility of conducting vigorous cool room treadmill training
Rest required (minutes)
Secondary Outcome Measures
Timed 25 foot walk test
Spatiotemporal parameters of gait measured while walking at fast and self-selected pace
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.
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.
Maximal oxygen consumption during graded exercise test
Health-related quality of life assessed using 36-Item Short-Form Health Survey
Serum brain derived neurotrophic factor
Resting and exercise-induced serum levels of brain derived neurotrophic factor in response to the 10-week exercise intervention
Serum interleukin-6
Resting and exercise-induced serum levels of interleukin-6 in response to the 10-week exercise intervention
Montreal cognitive assessment
Corticospinal excitability measured using transcranial magnetic stimulation
Body composition measured using dual energy x-ray absorptiometry
Magnetization transfer ratio measured using magnetic resonance imaging
Aerobic cost of walking
Step counts
Via Accelerometry
Full Information
NCT ID
NCT04066972
First Posted
August 20, 2019
Last Updated
August 23, 2019
Sponsor
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT04066972
Brief Title
Vigorous Cool Room Treadmill Training
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Rehabilitation, Gait Disorders, Neurologic, Neuronal Plasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a 'proof-of-principle/feasibility' within group repeated measures study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Body-weight supported treadmill training in a room cooled to 16°C
Other Intervention Name(s)
Vigorous cool room treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of conducting vigorous cool room treadmill training
Description
Recruitment and retention rates
Time Frame
10 weeks
Title
Feasibility of conducting vigorous cool room treadmill training
Description
Incidence of adverse events
Time Frame
10 weeks
Title
Feasibility of conducting vigorous cool room treadmill training
Description
Degree of body-weight support provided by the harness (%)
Time Frame
10 weeks
Title
Feasibility of conducting vigorous cool room treadmill training
Description
Rest required (minutes)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Timed 25 foot walk test
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Spatiotemporal parameters of gait measured while walking at fast and self-selected pace
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Fatigue severity scale
Description
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.
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Modified fatigue impact scale
Description
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.
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Maximal oxygen consumption during graded exercise test
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Health-related quality of life assessed using 36-Item Short-Form Health Survey
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Serum brain derived neurotrophic factor
Description
Resting and exercise-induced serum levels of brain derived neurotrophic factor in response to the 10-week exercise intervention
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Serum interleukin-6
Description
Resting and exercise-induced serum levels of interleukin-6 in response to the 10-week exercise intervention
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Montreal cognitive assessment
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Corticospinal excitability measured using transcranial magnetic stimulation
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Body composition measured using dual energy x-ray absorptiometry
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Magnetization transfer ratio measured using magnetic resonance imaging
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Aerobic cost of walking
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Title
Step counts
Description
Via Accelerometry
Time Frame
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 1E5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.
Citations:
PubMed Identifier
32168157
Citation
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.
Results Reference
derived
PubMed Identifier
31969132
Citation
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.
Results Reference
derived
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Vigorous Cool Room Treadmill Training
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