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Multiple SclerosisNCT04066972

Vigorous Cool Room Treadmill Training

A study testing Body-weight supported treadmill training in a room cooled to 16°C in people with Multiple Sclerosis and Rehabilitation, run by Memorial University of Newfoundland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Body-weight supported treadmill training in a room cooled to 16°C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
10 Jul 2018to 9 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Memorial University of Newfoundland

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

Other trials in Canada

About this study

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

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.

Being tested
Body-weight supported treadmill training in a room cooled to 16°C
Medical subject headings
Multiple Sclerosis, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Vigorous cool room treadmill training

    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.

Study groups in NCT04066972
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Other: Body-weight supported treadmill training in a room cooled to 16°C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of conducting vigorous cool room treadmill training

    Recruitment and retention rates

    Measured: 10 weeks

  2. Feasibility of conducting vigorous cool room treadmill training

    Incidence of adverse events

    Measured: 10 weeks

  3. Feasibility of conducting vigorous cool room treadmill training

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

    Measured: 10 weeks

  4. Feasibility of conducting vigorous cool room treadmill training

    Rest required (minutes)

    Measured: 10 weeks

Secondary outcomes (14)

  1. Timed 25 foot walk test

    Measured: 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

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

  3. Fatigue severity scale

    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.

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

  4. Modified fatigue impact scale

    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.

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

  5. Maximal oxygen consumption during graded exercise test

    Measured: 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

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

  7. Serum brain derived neurotrophic factor

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

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

  8. Serum interleukin-6

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

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

  9. Montreal cognitive assessment

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

  10. Corticospinal excitability measured using transcranial magnetic stimulation

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

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

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

  12. Magnetization transfer ratio measured using magnetic resonance imaging

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

  13. Aerobic cost of walking

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

  14. Step counts

    Via Accelerometry

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start10 Jul 2018
  3. Primary completion9 Jul 2019
  4. Study completion9 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a 'proof-of-principle/feasibility' within group repeated measures study.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066972
Sponsor's protocol ID
2018.088
Status last verified
Aug 2019
First submitted
20 Aug 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.

Publications

  • Chaves AR, Devasahayam AJ, Kelly LP, Pretty RW, Ploughman M. Exercise-Induced Brain Excitability Changes in Progressive Multiple Sclerosis: A Pilot Study. J Neurol Phys Ther. 2020 Apr;44(2):132-144. doi: 10.1097/NPT.0000000000000308.

    PubMed 32168157

  • Devasahayam AJ, Chaves AR, Lasisi WO, Curtis ME, Wadden KP, Kelly LP, Pretty R, Chen A, Wallack EM, Newell CJ, Williams JB, Kenny H, Downer MB, McCarthy J, Moore CS, Ploughman M. Vigorous cool room treadmill training to improve walking ability in people with multiple sclerosis who use ambulatory assistive devices: a feasibility study. BMC Neurol. 2020 Jan 22;20(1):33. doi: 10.1186/s12883-020-1611-0.

    PubMed 31969132

Questions about this trial

What is this clinical trial studying?

A study testing Body-weight supported treadmill training in a room cooled to 16°C in people with Multiple Sclerosis and Rehabilitation, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of conducting vigorous cool room treadmill training (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066972, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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