Multiple SclerosisNCT03638739
Exercise and Brain Health in MS
A study testing Twice-weekly exercise in people with Multiple Sclerosis, run by McMaster University at 1 site in Canada.
Trial summary
Physical activity is now recognized as a therapy for Multiple Sclerosis (MS) that not only improves physical fitness and functional mobility, but there is some evidence that it may also positively influence the more invisible symptoms of the disease that represent "brain health" - fatigue, depression and cognitive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Twice-weekly exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 1 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Relapsing-Remitting MS (RRMS) with mild-moderate disability (EDSS 2-5)
- Aged 18-60
- Score of ≥ 10 on MFIS-5*
- Medical clearance to participate in physical activity * The MFIS-5 is an abbreviated version of the 21-item MFIS, consisting of 5 of the 21 items of the MFIS that most strongly correlate with the total MFIS score. A score ≥ 10 on the MFIS-5 is considered to indicate "high-level" of fatigue
Who cannot join
- Current participation in regular physical activity (at least twice-weekly)
- Other serious medical condition that might impair ability to participate in strength or aerobic exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site
Physical Activity Centre for Excellence
Hamilton, Ontario, L8S 4K1
About this study
Official title: Exercise and Brain Health in Multiple Sclerosis: A Pilot Study
Physical activity is now recognized as a therapy for Multiple Sclerosis (MS) that not only improves physical fitness and functional mobility, but there is some evidence that it may also positively influence the more invisible symptoms of the disease that represent "brain health" - fatigue, depression and cognitive impairment. One important feature of physical activity is that it reduces inflammation throughout the body and the brain. The goal of this research is to determine whether people with MS feel less fatigue, depression and cognitive impairment after a program of exercise because there is a decrease in the state of inflammation in the brain.
Read the detailed description
Multiple Sclerosis (MS) is a chronic, degenerative disease of the central nervous system, characterized by inflammatory demyelination and axonal degeneration. MS affects approximately 1 in 500 Canadians. There is no cure for MS and the heterogeneous symptoms of the disease makes it difficult to prescribe effective treatment strategies for disease management. While the progression, severity and specific symptom profile vary from person to person, there are three key symptoms associated with brain health- fatigue, depression and cognitive impairment- that invariably lead to poor quality of life and increased health care costs. Unfortunately, the majority of people with MS suffer from these symptoms (fatigue affects ~90%, depression affects ~50% and cognitive impairment affects 40-65%) and a critical challenge with MS is that these symptoms do not present individually. For example, persons with MS who experience depression are more likely to also experience fatigue and/or cognitive impairment, which together may be more detrimental to quality of life than each symptom alone.
New evidence suggests that the three symptoms affecting brain health may be interrelated through a common mechanism of inflammation. Further, physical exercise is known to reduce inflammation and thus is a prime candidate for a novel therapeutic approach to symptom management through its effect on modulating the inflammatory response. Indeed, physical activity is already used to improve the physical status of individuals with MS and evidence-based physical activity guidelines (PAGs) for MS have been developed to guide prescription. However, the guidelines have not been tested for their effects on reducing inflammation and brain health disease systems. Therefore, the proposed research will be the first to evaluate the clinical utility of the PAGs for MS in reducing brain health disease symptoms and improving quality of life, and the first to comprehensively determine the putative effects of inflammation on these symptoms.
- Conditions
- Multiple Sclerosis
- Being tested
- Twice-weekly exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twice-weekly exerciseOther
An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS for 12 weeks at McMaster University. Following this, they will return to their normal daily activities for a further 12 weeks. Receives: Other: Twice-weekly exercise |
| Wait-list Control | Experimental | Participants will engage in their usual daily activities for the first 12 weeks of the study, then will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS at McMaster University for the 2nd 12 weeks. Receives: Other: Twice-weekly exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Fatigue
Changes in perceived fatigue as a result of the intervention will be assessed through changes in scores on the Modified Fatigue Impact Scale (MFIS-21).
Measured: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Inflammatory Markers
Inflammatory markers will be measured from the blood. Participants will have 15ml of blood drawn by a trained phlebotomist. Levels of serum cytokines (TNF, IL6, IL10, IL1RA) will be measured in using the custom created Milliplex MAP Human Magnetic Bead Panel (Millipore, ON, CA). Cellular immunophenotyping will be performed to test whether there are changes in cellular inflammation.
Measured: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Depression
Change in depression will be measured with the Hospital Anxiety and Depression Scale (HADS).
Measured: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in Cognition
Changes in cognitive ability will be assessed by using the Brief International Cognitive Assessment for MS (BICAMS) test battery.
Measured: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Secondary outcomes (3)
Change in Aerobic Capacity
Participants will perform a progressive exercise test on the cycle ergometer to determine peak oxygen consumption (aerobic capacity). Expired gas and ventilatory parameters will be acquired throughout the protocol using a metabolic cart allowing for the determination of submaximal and maximal oxygen consumption.
Measured: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Muscle Strength
The maximum weight that can be lifted in one repetition (1RM) will be assessed in major muscle groups of the upper and lower body to assess muscle strength.
Measured: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Perceived Quality of Life (QOL)
Health-related quality of life will be assessed by the disease-specific MS Quality of Life-54 (MSQoL-54) questionnaire.
Measured: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Aug 2018
- Primary completion30 Jun 2019
- Study completion1 Sep 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638739
- Sponsor's protocol ID
- RG-1707-28348
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 5 Mar 2021
- 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Brain Health in Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03638739
- Acronym / sponsor ID
- RG-1707-28348
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Aug 2018 (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.
Physical activity is now recognized as a therapy for Multiple Sclerosis (MS) that not only improves physical fitness and functional mobility, but there is some evidence that it may also positively influence the more invisible symptoms of the disease that represent "brain health" - fatigue, depression and cognitive impairment. One important feature of physical activity is that it reduces inflammation throughout the body and the brain. The goal of this research is to determine whether people with MS feel less fatigue, depression and cognitive impairment after a program of exercise because there is a decrease in the state of inflammation in the brain.
Detailed description
Multiple Sclerosis (MS) is a chronic, degenerative disease of the central nervous system, characterized by inflammatory demyelination and axonal degeneration. MS affects approximately 1 in 500 Canadians. There is no cure for MS and the heterogeneous symptoms of the disease makes it difficult to prescribe effective treatment strategies for disease management. While the progression, severity and specific symptom profile vary from person to person, there are three key symptoms associated with brain health- fatigue, depression and cognitive impairment- that invariably lead to poor quality of life and increased health care costs. Unfortunately, the majority of people with MS suffer from these symptoms (fatigue affects ~90%, depression affects ~50% and cognitive impairment affects 40-65%) and a critical challenge with MS is that these symptoms do not present individually. For example, persons with MS who experience depression are more likely to also experience fatigue and/or cognitive impairment, which together may be more detrimental to quality of life than each symptom alone.
New evidence suggests that the three symptoms affecting brain health may be interrelated through a common mechanism of inflammation. Further, physical exercise is known to reduce inflammation and thus is a prime candidate for a novel therapeutic approach to symptom management through its effect on modulating the inflammatory response. Indeed, physical activity is already used to improve the physical status of individuals with MS and evidence-based physical activity guidelines (PAGs) for MS have been developed to guide prescription. However, the guidelines have not been tested for their effects on reducing inflammation and brain health disease systems. Therefore, the proposed research will be the first to evaluate the clinical utility of the PAGs for MS in reducing brain health disease symptoms and improving quality of life, and the first to comprehensively determine the putative effects of inflammation on these symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Twice-weekly exerciseParticipants will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS for 12 weeks at McMaster University. Following this, they will return to their normal daily activities for a further 12 weeks. |
| Wait-list Control | Experimental | Other: Twice-weekly exerciseParticipants will engage in their usual daily activities for the first 12 weeks of the study, then will engage in supervised, twice-weekly exercise following the Physical Activity Guidelines for Adults with MS at McMaster University for the 2nd 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Relapsing-Remitting MS (RRMS) with mild-moderate disability (EDSS 2-5)
- Aged 18-60
- Score of ≥ 10 on MFIS-5*
- Medical clearance to participate in physical activity * The MFIS-5 is an abbreviated version of the 21-item MFIS, consisting of 5 of the 21 items of the MFIS that most strongly correlate with the total MFIS score. A score ≥ 10 on the MFIS-5 is considered to indicate "high-level" of fatigue
Key exclusion criteria (2 listed)
- Current participation in regular physical activity (at least twice-weekly)
- Other serious medical condition that might impair ability to participate in strength or aerobic exercise
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 |
|---|---|---|
| Twice-weekly exerciseAn individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant. | Other | Exercise, Wait-list Control |
Primary outcome
Change in Perceived Fatigue
Time frame: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Changes in perceived fatigue as a result of the intervention will be assessed through changes in scores on the Modified Fatigue Impact Scale (MFIS-21).
Change in Inflammatory Markers
Time frame: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Inflammatory markers will be measured from the blood. Participants will have 15ml of blood drawn by a trained phlebotomist. Levels of serum cytokines (TNF, IL6, IL10, IL1RA) will be measured in using the custom created Milliplex MAP Human Magnetic Bead Panel (Millipore, ON, CA). Cellular immunophenotyping will be performed to test whether there are changes in cellular inflammation.
Change in Depression
Time frame: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Change in depression will be measured with the Hospital Anxiety and Depression Scale (HADS).
Change in Cognition
Time frame: Outcome will be measured at Baseline, 12 weeks and 24 weeks.
Changes in cognitive ability will be assessed by using the Brief International Cognitive Assessment for MS (BICAMS) test battery.
3 secondary outcomes
Change in Aerobic Capacity
Time frame: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Muscle Strength
Time frame: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Change in Perceived Quality of Life (QOL)
Time frame: Outcomes will be measured at Baseline, 12 weeks and 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twice-weekly exercise in people with Multiple Sclerosis, run by McMaster University 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 2 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 5 Mar 2021. 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?
Change in Perceived Fatigue (time frame: Outcome will be measured at Baseline, 12 weeks and 24 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?
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 5 Mar 2021.