Multiple SclerosisNCT02466165
Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy
A study testing Physical exercise in people with Multiple Sclerosis and Healthy Controls, run by Bert Op't Eijnde at 2 sites in Belgium.
Trial summary
Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in young adults. Due to heterogeneous symptoms, MS patients are often more inactive than healthy controls, resulting in an inactivity related physiological profile. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Controls
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2015to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy controls:
- male/female
- 18 years
- written informed consent (Declaration of Helsinki and ethical committee guidelines)
- MS patients:
- cfr healthy controls criteria, in addition:
Show all 9Show fewer
- Diagnosed MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 1 and 7
- Being available for the complete study course
Who cannot join
- other disorders
- pregnancy
- participation in another study
- MS exacerbation 6 months prior to the start.
- for the MS patients: contra-indication to perform physical exercise
Trial locations and contacts
2 sites in 1 country.
About this study
Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in young adults. Due to heterogeneous symptoms, MS patients are often more inactive than healthy controls, resulting in an inactivity related physiological profile. In healthy people, physical inactivity can contribute to the development of an increased cardiometabolic risk state including the combined presence of cardiovascular risk factors (increased cholesterol, elevated blood pressure, body fat, glucose intolerance/insulin resistance, inflammation and reduced heart function/autonomic control). In other populations, these secondary health complications can be, in part, reduced by physical exercise, which is often used as the primary treatment strategy. Since the impact of exercise on cardiovascular risk factors in MS is unknown the present project first aims to explore this in a pilot trial and a controlled research setting (during 12 weeks). A better understanding of the above described risk factors and underlying physiological mechanisms will reduce the incidence of preventable comorbidities in MS and will further improve the multidisciplinary treatment of MS patients and MS rehabilitation in particular. Interestingly, the investigators already reported an elevated prevalence of impaired glucose tolerance in MS, but it is not clear whether the cardiometabolic state in MS is also impaired. Therefore, in a second part, the researchers will explore whether MS patients present a higher risk to develop cardiovascular diseases, as measured by the assessment of various cardiovascular risk factors, compared to healthy controls.
Read the detailed description
In a first part, various cardiovascular risk factors will be determined in a group of MS patients (n=~16). These patients will be enrolled in a pilot trail, investigating the feasability and impact of a high intense interval exercise intervention (12 weeks high intensity interval training). After 12 weeks, baseline cardiovascular risk measurements will be repeated to determine the impact of high intensity interval training on these risk factors in MS.
In a second part, these cardiovascular risk factors in a larger group of MS patients (n=~50) will be compared to healthy controls (n=~25), in order to determine whether MS patients show an increased prevalence of cardiovascular risk factors, and thus an elevated risk to develop cardiovascular diseases.
In total, a group of 80 subjects (MS patients and HC) will be investigated throughout this study, with only MS patients participating in the pilot trial/exercise intervention.
Measurements of cardiovascular risk factors will include:
- body composition (DEXA)
- blood pressure and heart rate (Omron M4-I)
- whole body glucose disposal (oral glucose tolerance test)
- blood analysis: insulin, total cholesterol, high- density lipoprotein, low-density lipoprotein, plasma triglycerides, C-reactive protein and glycosylated haemoglobin.
Furthermore, a maximal exercise test (determination maximal heart rate, workload, lactate concentrations, etc) and an isometric/isokinetic strength test will be performed to determine the impact of the rehabilitation program in MS patients.
- Conditions
- Multiple Sclerosis, Healthy Controls
- Being tested
- Physical exercise
- Keywords
- cardiometabolic risk, physical exercise
- 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.
Physical exerciseBehavioural
Also called combined (endurance and resistance) exercise programme
| Study group | Role | What they receive |
|---|---|---|
| MS patients intervention group | Experimental | the feasibilty and influence of high intense interval exercise on the cardiometabolic risk state in MS patients will be investigated in a pilot trial. Receives: Behavioral: Physical exercise |
| healthy controls | No intervention | To identify whether MS patients have a higher cardiometabolic risk state than healthy controls, this project discovers the prevalence of cardiometabolic risk factors (dyslipidemia, hypertension, body fat, glucose tolerance/IR, inflammation and heart function), in MS and referent subjects. |
| larger group of MS patients | No intervention | To identify whether MS patients have a higher cardiometabolic risk state than healthy controls, this project discovers the prevalence of cardiometabolic risk factors (dyslipidemia, hypertension, body fat, glucose tolerance/IR, inflammation and heart function), in MS and referent subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyslipidemia, as determined by the analysis of blood samples
measured at baseline and after 12 of exercise Blood samples will be analysed to determine complete blood lipid profile.
Measured: change from baseline up to 12 weeks
hypertension / blood pressure as determined by supine blood pressure measures
measured at baseline and after 12 of exercise Blood pressure will be evaluated supine.
Measured: change from baseline up to 12 weeks
body fat as determined by DEXA scan
measured at baseline and after 12 weeks of exercise Body composition will be determined by means of a Dexa scan.
Measured: change from baseline up to 12 weeks
glucose tolerance / insulin resistance as determined by oral glucose tolerance test
measured at baseline and after 12 weeks of exercise Glucose tolerance will be evaluated by means of an oral glucose tolerance test. Collected blood samples will be analysed to determine insulin concentrations
Measured: change from baseline up to 12 weeks
inflammation as determined by analysis of blood samples
measured at baseline and after 12 weeks of exercise Blood samples, as collected during the oral glucose tolerance test, will be analysed to evaluate inflammation (CRP etc)
Measured: change from baseline up to 12 weeks
Secondary outcomes (4)
muscle strength of knee extensor/flexor and elbow extensor/flexor as determined by Biodex
measured at baseline and after 12 weeks of exercise Muscle strength will be evaluated by means of the Biodex
Measured: change from baseline up to 12 weeks
aerobic capacity as determined by a maximal endurance test on the bike
measured at baseline and after 12 weeks of exercise Aerobic capacity will be tested during a maximal endurance test on the bike
Measured: change from baseline up to 12 weeks
blood lactate concentrations during exercise as determined by a maximal endurance test on the bike
measured at baseline and after 12 weeks of exercise Lactate concentrations (mmol/L) will be tested during a maximal endurance test on the bike
Measured: change from baseline up to 12 weeks
heart function
measured at baseline and after 12 and 24 weeks of exercise
Measured: change from baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionDec 2015
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bert Op't Eijnde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Bert O Eijnde, Ph.D., Study chair, Hasselt University, REVAL/BIOMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466165
- Sponsor's protocol ID
- MS-CMR
- Status last verified
- Jun 2017
- First submitted
- 9 Mar 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy
- ClinicalTrials.gov ID
- NCT02466165
- Acronym / sponsor ID
- MS-CMR
- Conditions
- Multiple Sclerosis, Healthy Controls
- Keywords
- cardiometabolic risk, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bert Op't EijndeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in young adults. Due to heterogeneous symptoms, MS patients are often more inactive than healthy controls, resulting in an inactivity related physiological profile. In healthy people, physical inactivity can contribute to the development of an increased cardiometabolic risk state including the combined presence of cardiovascular risk factors (increased cholesterol, elevated blood pressure, body fat, glucose intolerance/insulin resistance, inflammation and reduced heart function/autonomic control). In other populations, these secondary health complications can be, in part, reduced by physical exercise, which is often used as the primary treatment strategy. Since the impact of exercise on cardiovascular risk factors in MS is unknown the present project first aims to explore this in a pilot trial and a controlled research setting (during 12 weeks). A better understanding of the above described risk factors and underlying physiological mechanisms will reduce the incidence of preventable comorbidities in MS and will further improve the multidisciplinary treatment of MS patients and MS rehabilitation in particular. Interestingly, the investigators already reported an elevated prevalence of impaired glucose tolerance in MS, but it is not clear whether the cardiometabolic state in MS is also impaired. Therefore, in a second part, the researchers will explore whether MS patients present a higher risk to develop cardiovascular diseases, as measured by the assessment of various cardiovascular risk factors, compared to healthy controls.
Detailed description
In a first part, various cardiovascular risk factors will be determined in a group of MS patients (n=~16). These patients will be enrolled in a pilot trail, investigating the feasability and impact of a high intense interval exercise intervention (12 weeks high intensity interval training). After 12 weeks, baseline cardiovascular risk measurements will be repeated to determine the impact of high intensity interval training on these risk factors in MS.
In a second part, these cardiovascular risk factors in a larger group of MS patients (n=~50) will be compared to healthy controls (n=~25), in order to determine whether MS patients show an increased prevalence of cardiovascular risk factors, and thus an elevated risk to develop cardiovascular diseases.
In total, a group of 80 subjects (MS patients and HC) will be investigated throughout this study, with only MS patients participating in the pilot trial/exercise intervention.
Measurements of cardiovascular risk factors will include:
- body composition (DEXA)
- blood pressure and heart rate (Omron M4-I)
- whole body glucose disposal (oral glucose tolerance test)
- blood analysis: insulin, total cholesterol, high- density lipoprotein, low-density lipoprotein, plasma triglycerides, C-reactive protein and glycosylated haemoglobin.
Furthermore, a maximal exercise test (determination maximal heart rate, workload, lactate concentrations, etc) and an isometric/isokinetic strength test will be performed to determine the impact of the rehabilitation program in MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MS patients intervention group | Experimental | Behavioral: Physical exercisethe feasibilty and influence of high intense interval exercise on the cardiometabolic risk state in MS patients will be investigated in a pilot trial. |
| healthy controls | No intervention | –To identify whether MS patients have a higher cardiometabolic risk state than healthy controls, this project discovers the prevalence of cardiometabolic risk factors (dyslipidemia, hypertension, body fat, glucose tolerance/IR, inflammation and heart function), in MS and referent subjects. |
| larger group of MS patients | No intervention | –To identify whether MS patients have a higher cardiometabolic risk state than healthy controls, this project discovers the prevalence of cardiometabolic risk factors (dyslipidemia, hypertension, body fat, glucose tolerance/IR, inflammation and heart function), in MS and referent subjects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male/female
- 18 years
- written informed consent (Declaration of Helsinki and ethical committee guidelines)
- cfr healthy controls criteria, in addition:
- Diagnosed MS according to the McDonald criteria
Key exclusion criteria (5 listed)
- other disorders
- pregnancy
- participation in another study
- MS exacerbation 6 months prior to the start.
- for the MS patients: contra-indication to perform physical 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 |
|---|---|---|
| Physical exerciseAlso: combined (endurance and resistance) exercise programme | Behavioural | MS patients intervention group |
Primary outcome
dyslipidemia, as determined by the analysis of blood samples
Time frame: change from baseline up to 12 weeks
measured at baseline and after 12 of exercise Blood samples will be analysed to determine complete blood lipid profile.
hypertension / blood pressure as determined by supine blood pressure measures
Time frame: change from baseline up to 12 weeks
measured at baseline and after 12 of exercise Blood pressure will be evaluated supine.
body fat as determined by DEXA scan
Time frame: change from baseline up to 12 weeks
measured at baseline and after 12 weeks of exercise Body composition will be determined by means of a Dexa scan.
glucose tolerance / insulin resistance as determined by oral glucose tolerance test
Time frame: change from baseline up to 12 weeks
measured at baseline and after 12 weeks of exercise Glucose tolerance will be evaluated by means of an oral glucose tolerance test. Collected blood samples will be analysed to determine insulin concentrations
inflammation as determined by analysis of blood samples
Time frame: change from baseline up to 12 weeks
measured at baseline and after 12 weeks of exercise Blood samples, as collected during the oral glucose tolerance test, will be analysed to evaluate inflammation (CRP etc)
4 secondary outcomes
muscle strength of knee extensor/flexor and elbow extensor/flexor as determined by Biodex
Time frame: change from baseline up to 12 weeks
aerobic capacity as determined by a maximal endurance test on the bike
Time frame: change from baseline up to 12 weeks
blood lactate concentrations during exercise as determined by a maximal endurance test on the bike
Time frame: change from baseline up to 12 weeks
heart function
Time frame: change from baseline up to 12 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 20 Jun 2017.
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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.
Bert O Eijnde, Ph.D. study chair
Hasselt University, REVAL/BIOMED
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Multiple Sclerosis and Healthy Controls, run by Bert Op't Eijnde at 2 sites in Belgium.
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 9 inclusion and 5 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
dyslipidemia, as determined by the analysis of blood samples (time frame: change from baseline up to 12 weeks). The study lists 5 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 20 Jun 2017.