Vigorous Cool Room Treadmill Training

Intensive Aerobic and Task-specific Training to Restore Walking and Boost Neuroplasticity Among People With MS-related Walking Disability: a Proof of Principle Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 1E5
      • Memorial University of Newfoundland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm

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 (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.; Other Names: Vigorous cool room treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of conducting vigorous cool room treadmill training	Recruitment and retention rates	10 weeks
Feasibility of conducting vigorous cool room treadmill training	Incidence of adverse events	10 weeks
Feasibility of conducting vigorous cool room treadmill training	Degree of body-weight support provided by the harness (%)	10 weeks
Feasibility of conducting vigorous cool room treadmill training	Rest required (minutes)	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed 25 foot walk test		Following completion of the 10-week exercise intervention and 3-months post-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	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
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
Maximal oxygen consumption during graded exercise test		Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
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
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
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
Body composition measured using dual energy x-ray absorptiometry		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	Via Accelerometry	Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2018.088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No