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Completed

NCT Number: NCT04066972

Vigorous Cool Room Treadmill Training

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Nervous System Diseases Neurologic Manifestations Neuronal Plasticity Pathological Conditions, Signs and Symptoms Rehabilitation Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial University of Newfoundland

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

A total of 30 training sessions will be conducted in 10 weeks for 30 minutes per session and 3 times per week in a cool room (16⁰ C) on a treadmill that is equipped with safety straps to prevent falls. A pneumatic harness system will be used to provide 10% body-weight support during training sessions. The participants will start exercising on the treadmill at 80% of their self-selected walking speed with 1% incline and will increase as per their tolerance (will progress weekly based on 40-65% heart rate reserve). Heart rate, perceived fatigue and rating of perceived exertion will be monitored continuously during exercise sessions. Initial training will commence with intermittent rest periods [1 to 5 minutes] as requested by the participants and will be progressed to a maximum of 30-minute continuous treadmill walking.

Other names: Vigorous cool room treadmill training

Primary outcomes

  1. Feasibility of conducting vigorous cool room treadmill training

    Time frame: 10 weeks

    Recruitment and retention rates

  2. Feasibility of conducting vigorous cool room treadmill training

    Time frame: 10 weeks

    Incidence of adverse events

  3. Feasibility of conducting vigorous cool room treadmill training

    Time frame: 10 weeks

    Degree of body-weight support provided by the harness (%)

  4. Feasibility of conducting vigorous cool room treadmill training

    Time frame: 10 weeks

    Rest required (minutes)

Secondary outcomes

  1. Timed 25 foot walk test

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

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

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

  3. Fatigue severity scale

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

    A 9-item questionnaire, which assesses the severity of fatigue with items scored on a 7-point scale, '1 = strongly disagree' and '7 = strongly agree'. The minimum and maximum score possible are 9 and 63 respectively. Another reporting method is the mean of all scores from all 9-items, with minimum and maximum score possible being 1 and 7 respectively.

  4. Modified fatigue impact scale

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

    A 21-item scale, which assesses the perceived impact of fatigue with items rated by participants on a 5-point Likert scale, '0 = never' to '4 = almost always'. The items are aggregated into total score as well as three subscales: physical, cognitive, and psychosocial. The total score ranges from 0 to 84, physical subscale from 0 to 36, cognitive subscale from 0 to 40, and psychosocial subscale from 0 to 8.

  5. Maximal oxygen consumption during graded exercise test

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

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

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

  7. Serum brain derived neurotrophic factor

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

    Resting and exercise-induced serum levels of brain derived neurotrophic factor in response to the 10-week exercise intervention

  8. Serum interleukin-6

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

    Resting and exercise-induced serum levels of interleukin-6 in response to the 10-week exercise intervention

  9. Montreal cognitive assessment

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

  10. Corticospinal excitability measured using transcranial magnetic stimulation

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

  11. Body composition measured using dual energy x-ray absorptiometry

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

  12. Magnetization transfer ratio measured using magnetic resonance imaging

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

  13. Aerobic cost of walking

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

  14. Step counts

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

    Via Accelerometry

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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