Vigorous Cool Room Treadmill Training

NCT04066972 | Completed

• 1 other identifier: 2018.088
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Rehabilitation; Gait Disorders, Neurologic; Neuronal Plasticity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• 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

  Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

• Modified fatigue impact scale

  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

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

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

Also known as: Vigorous cool room treadmill training

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1A 1E5, Canada

Location

Related Publications (2)

• 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.

  PMID: 32168157 DERIVED

• 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.

  PMID: 31969132 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is a 'proof-of-principle/feasibility' within group repeated measures study.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: July 10, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)