Vigorous Cool Room Treadmill Training

August 23, 2019 updated by: Michelle Ploughman, Memorial University of Newfoundland

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 1E5
        • Memorial University of Newfoundland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Vigorous cool room treadmill training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of conducting vigorous cool room treadmill training
Time Frame: 10 weeks
Recruitment and retention rates
10 weeks
Feasibility of conducting vigorous cool room treadmill training
Time Frame: 10 weeks
Incidence of adverse events
10 weeks
Feasibility of conducting vigorous cool room treadmill training
Time Frame: 10 weeks
Degree of body-weight support provided by the harness (%)
10 weeks
Feasibility of conducting vigorous cool room treadmill training
Time Frame: 10 weeks
Rest required (minutes)
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed 25 foot walk test
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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.
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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.
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Maximal oxygen consumption during graded exercise test
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Montreal cognitive assessment
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Corticospinal excitability measured using transcranial magnetic stimulation
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
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
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Magnetization transfer ratio measured using magnetic resonance imaging
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Aerobic cost of walking
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Step counts
Time Frame: Following completion of the 10-week exercise intervention and 3-months post-exercise intervention
Via Accelerometry
Following completion of the 10-week exercise intervention and 3-months post-exercise intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018.088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data supporting this study are available at request from the corresponding author at the Memorial University of Newfoundland, Canada.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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