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

NCT04175054 | Withdrawn

• 1 other identifier: 20201156
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fast walking speed

  Gait velocity (cm/s) measured while walking at fast pace

  12 weeks

Secondary Outcomes (10)

• Spatiotemporal parameters of gait measured while walking at self-selected pace

  Following completion of the 12-week exercise intervention and 3-months post-exercise intervention

• Maximal oxygen consumption during graded exercise test

  Following completion of the 12-week exercise intervention and 3-months post-exercise intervention

• Multiple Sclerosis Impact Scale-29

  Following completion of the 12-week exercise intervention and 3-months post-exercise intervention

• Fatigue Severity Scale

  Following completion of the 12-week exercise intervention and 3-months post-exercise intervention

• Hospital Anxiety and Depression Scale

  Following completion of the 12-week exercise intervention and 3-months post-exercise intervention

Study Arms (2)

Low Intensity Group

ACTIVE COMPARATOR

Less than 40% Heart Rate Reserve

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

Vigorous Intensity Group

EXPERIMENTAL

More than 60% Heart Rate Reserve

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

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.

Low Intensity Group; Vigorous Intensity Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

Memorial University of Newfoundland

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

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Michelle Ploughman, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation, and will not be involved in conducting the training intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is an assessor-blinded Randomized Controlled Trial.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)