Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People with Multiple Sclerosis

NCT ID: NCT04175054

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2030-01-31
• Study Completion Date: 2030-02-28

Brief Summary

New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.

Detailed Description

Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity. As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS. Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking. Our second objective is to determine whether treadmill training alters indicators of brain repair. We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up. We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.

Conditions

Multiple Sclerosis; Neurological Rehabilitation; Exercise; Neuronal Plasticity; Cooling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low Intensity Group

Less than 40% Heart Rate Reserve

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload \>60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (\<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.

Vigorous Intensity Group

More than 60% Heart Rate Reserve

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload \>60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (\<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.

Interventions

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

Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload \>60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (\<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• people with a confirmed diagnosis of relapsing-remitting or progressive MS
• older than 18 and less than 70 years of age
• able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) <7.0)
• must be stable without relapse for at least 90 days

Exclusion Criteria

• currently attending physical rehabilitation
• functional community ambulators (gait speed>120 cm/s)
• a relapse of MS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Multiple Sclerosis Society of Canada

OTHER

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Michelle Ploughman

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Ploughman, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

Other Identifiers

20201156

Identifier Type: -

Identifier Source: org_study_id