Vigorous Cool Room Treadmill Training

Intensive Aerobic and Task-specific Training to Restore Walking and Boost Neuroplasticity Among People With MS-related Walking Disability: a Proof of Principle Trial

CompletedNot a drug-phase studyMS (type not specified)NCT04066972

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

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

What it measured

Main measures

  • Feasibility of conducting vigorous cool room treadmill training

    10 weeks

    FeasibilitySafety

Other measures (14)

  • Timed 25 foot walk test

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Disability progressionWalking and mobility

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

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Walking and mobility

  • Fatigue severity scale

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Fatigue

  • Modified fatigue impact scale

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Thinking and memoryFatigue

  • Maximal oxygen consumption during graded exercise test

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Physical function

  • Health-related quality of life assessed using 36-Item Short-Form Health Survey

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Quality of life (reported by participants)

  • Serum brain derived neurotrophic factor

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Physical function

  • Serum interleukin-6

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Physical functionImmune response

  • Montreal cognitive assessment

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

    Thinking and memory

  • Corticospinal excitability measured using transcranial magnetic stimulation

    Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

Who could take part

MS (type not specified) · 18 to 75 · EDSS 6.0 to 7.0

Show the full criteria

Inclusion criteria

* clinically definite MS * relapse-free in the previous 3 months * requiring ambulatory assistive devices (EDSS 6.0-7.0) * negative PAR-Q screen for risk factors * greater than 6-weeks post Botulinum Toxin injection (if received) in the lower extremity

Exclusion criteria

* pregnancy or intention of becoming pregnant * finished a drug/device study in the last 30 days * over 75 years of age * unable to control bowel and bladder on physical exertion * currently attending physical rehabilitation * having no difficulty walking in the community (self-selected walking speed >120 cm/s)

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

About this trial

In the sponsor's words

People with multiple sclerosis (MS) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. We have developed a cool room treadmill training method that uses body-weight support that people with MS fatigue and heat sensitivity can tolerate. Our previous research shows that people with advanced MS use three times more energy for essential tasks such as walking. This project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking, fitness and fatigue in people with advanced MS.

Papers

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History

    1. Started

      Jul 2018

    2. Main results due

      Jul 2019

    3. Finished

      Jul 2019

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