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

Memorial University of Newfoundland

Status: Withdrawn

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04175054

20201156

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Low Intensity Group

Active Comparator group

Description:

Less than 40% Heart Rate Reserve

Treatment:

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

Vigorous Intensity Group

Experimental group

Description:

More than 60% Heart Rate Reserve

Treatment:

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