Clinical trial NCT04175054: Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People with Multiple Sclerosis
Official title: Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Neurological Rehabilitation
Exercise
Neuronal Plasticity
Cooling
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Canada
First posted: 2019-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an assessor-blinded Randomized Controlled Trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fast walking speed
timeFrame: 12 weeks
Secondary outcomes:
measure: Spatiotemporal parameters of gait measured while walking at self-selected pace
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Maximal oxygen consumption during graded exercise test
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Multiple Sclerosis Impact Scale-29
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Fatigue Severity Scale
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Hospital Anxiety and Depression Scale
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Montreal Cognitive Assessment
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Symbol Digit Modality Test
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Transcranial Magnetic Stimulation
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Serum Insulin-like growth factor-1 (IGF-1)
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
measure: Structural and functional brain changes on Magnetic Resonance Imaging (MRI)
timeFrame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Michelle Ploughman, PhD
role: PRINCIPAL_INVESTIGATOR
References: