MSFrontier

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

Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
WithdrawnNot a drug-phase studyRelapsing and progressiveNCT04175054

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Study no longer feasible.

What was tested

Treatment tested

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

What it measured

Main measures

  • Fast walking speed

    12 weeks

    Walking and mobility

Other measures (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

    Walking and mobility

  • Maximal oxygen consumption during graded exercise test

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

    Physical function

  • Multiple Sclerosis Impact Scale-29

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

    Walking and mobility

  • Fatigue Severity Scale

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

    Fatigue

  • Hospital Anxiety and Depression Scale

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

    Mood and sleep

  • Montreal Cognitive Assessment

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

    Thinking and memory

  • Symbol Digit Modality Test

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

    Thinking and memory

  • Transcranial Magnetic Stimulation

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

  • Serum Insulin-like growth factor-1 (IGF-1)

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

    Physical function

  • Structural and functional brain changes on Magnetic Resonance Imaging (MRI)

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

    MRI lesionsNerve conduction tests

Who could take part

Relapsing and progressive · 18 to 70

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2030

    2. Main results due

      Feb 2030

    3. Finished

      Feb 2030

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