Multiple SclerosisNCT04175054
Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People with Multiple Sclerosis
A study testing Body-weight supported treadmill training in a room cooled to 16°C in people with Multiple Sclerosis and Neurological Rehabilitation, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Neurological Rehabilitation, Exercise
- 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
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2030to Feb 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people with a confirmed diagnosis of relapsing-remitting or progressive MS
- older than 18 and less than 70 years of age
- able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) <7.0)
- must be stable without relapse for at least 90 days
Who cannot join
- currently attending physical rehabilitation
- functional community ambulators (gait speed>120 cm/s)
- a relapse of MS
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1A 1E5
About this study
Official title: Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.
Read the detailed description
Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity. As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS. Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking. Our second objective is to determine whether treadmill training alters indicators of brain repair. We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up. We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.
- Being tested
- Body-weight supported treadmill training in a room cooled to 16°C
- Medical subject headings
- Multiple Sclerosis, Motor Activity
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
Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload >60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Group | Active comparator | Less than 40% Heart Rate Reserve Receives: Other: Body-weight supported treadmill training in a room cooled to 16°C |
| Vigorous Intensity Group | Experimental | More than 60% Heart Rate Reserve 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.
Fast walking speed
Gait velocity (cm/s) measured while walking at fast pace
Measured: 12 weeks
Secondary outcomes (10)
Spatiotemporal parameters of gait measured while walking at self-selected pace
Walkway outputs include step length and width (cm), double support time (%), symmetry (ratio between affected and less-affected sides)
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Maximal oxygen consumption during graded exercise test
VO2max
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Multiple Sclerosis Impact Scale-29
The Multiple Sclerosis Impact Scale-29 provides physical and psychological sub-scales. Using a Likert scale, participants indicate the degree to which problems, such as 'moving about' and 'balance' affect them from 'not at all' to 'extremely'.
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
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 12-week exercise intervention and 3-months post-exercise intervention
Hospital Anxiety and Depression Scale
A self-reported rating scale of severity of mood symptoms ranging from 0-21 with higher score indicating more symptoms.
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Montreal Cognitive Assessment
Measures overall cognitive function with score ranging from 0 to 30 with higher scores indicating higher executive function
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Symbol Digit Modality Test
Cognitive impairment
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Transcranial Magnetic Stimulation
Corticospinal excitability
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Serum Insulin-like growth factor-1 (IGF-1)
Resting and exercise-induced serum levels of IGF-1 in response to the 12-week exercise intervention
Measured: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Structural and functional brain changes on Magnetic Resonance Imaging (MRI)
Standardized protocol recommended by the Canadian Dementia Imaging Group (https://www.cdip-pcid.ca/) which includes T1 and T2-weighted structural images, diffusion tensor imaging, and resting state connectivity.
Measured: Following completion of the 12-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.
- First posted22 Nov 2019
- Study startJan 2030 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Why it stopped: Study no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an assessor-blinded Randomized Controlled Trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Michelle Ploughman, Memorial University of Newfoundland
- Investigators
- Michelle Ploughman, PhD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175054
- Sponsor's protocol ID
- 20201156
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2019
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
- ClinicalTrials.gov ID
- NCT04175054
- Acronym / sponsor ID
- 20201156
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- Jan 2030 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.
Detailed description
Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity. As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS. Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking. Our second objective is to determine whether treadmill training alters indicators of brain repair. We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up. We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is an assessor-blinded Randomized Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Group | Active comparator | Other: Body-weight supported treadmill training in a room cooled to 16°CLess than 40% Heart Rate Reserve |
| Vigorous Intensity Group | Experimental | Other: Body-weight supported treadmill training in a room cooled to 16°CMore than 60% Heart Rate Reserve |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- people with a confirmed diagnosis of relapsing-remitting or progressive MS
- older than 18 and less than 70 years of age
- able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) <7.0)
- must be stable without relapse for at least 90 days
Key exclusion criteria (3 listed)
- currently attending physical rehabilitation
- functional community ambulators (gait speed>120 cm/s)
- a relapse of MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body-weight supported treadmill training in a room cooled to 16°CExercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload >60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects. | Other | Low Intensity Group, Vigorous Intensity Group |
Primary outcome
Fast walking speed
Time frame: 12 weeks
Gait velocity (cm/s) measured while walking at fast pace
10 secondary outcomes
Spatiotemporal parameters of gait measured while walking at self-selected pace
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Maximal oxygen consumption during graded exercise test
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Multiple Sclerosis Impact Scale-29
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Fatigue Severity Scale
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Hospital Anxiety and Depression Scale
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Montreal Cognitive Assessment
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Symbol Digit Modality Test
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Transcranial Magnetic Stimulation
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Serum Insulin-like growth factor-1 (IGF-1)
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Structural and functional brain changes on Magnetic Resonance Imaging (MRI)
Time frame: Following completion of the 12-week exercise intervention and 3-months post-exercise intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Ploughman, PhD principal investigator
Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
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 Neurological 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 Nov 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fast walking speed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2024.