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Vigorous Cool Room Treadmill Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066972
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Ploughman, Memorial University of Newfoundland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Rehabilitation Gait Disorders, Neurologic Neuronal Plasticity Other: Body-weight supported treadmill training in a room cooled to 16°C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a 'proof-of-principle/feasibility' within group repeated measures study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : July 9, 2019
Actual Study Completion Date : July 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Single arm Other: Body-weight supported treadmill training in a room cooled to 16°C
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 Name: Vigorous cool room treadmill training




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066972


Locations
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Canada, Newfoundland and Labrador
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1A 1E5
Sponsors and Collaborators
Memorial University of Newfoundland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michelle Ploughman, Assistant Professor of Medicine, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT04066972    
Other Study ID Numbers: 2018.088
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Gait Disorders, Neurologic
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms