- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466165
Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Diepenbeek, Belgium, 3590
- REVAL
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Hasselt, Belgium, 3500
- Jessa Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy controls:
- male/female
- 18 years
- written informed consent (Declaration of Helsinki and ethical committee guidelines)
MS patients:
- cfr healthy controls criteria, in addition:
- Diagnosed MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 1 and 7
- Being available for the complete study course
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MS patients intervention group
the feasibilty and influence of high intense interval exercise on the cardiometabolic risk state in MS patients will be investigated in a pilot trial.
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Other Names:
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No Intervention: healthy controls
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.
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No Intervention: larger group of MS patients
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dyslipidemia, as determined by the analysis of blood samples
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 of exercise Blood samples will be analysed to determine complete blood lipid profile.
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change from baseline up to 12 weeks
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hypertension / blood pressure as determined by supine blood pressure measures
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 of exercise Blood pressure will be evaluated supine.
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change from baseline up to 12 weeks
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body fat as determined by DEXA scan
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 weeks of exercise Body composition will be determined by means of a Dexa scan.
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change from baseline up to 12 weeks
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glucose tolerance / insulin resistance as determined by oral glucose tolerance test
Time Frame: change from baseline up to 12 weeks
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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
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change from baseline up to 12 weeks
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inflammation as determined by analysis of blood samples
Time Frame: change from baseline up to 12 weeks
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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)
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change from baseline up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle strength of knee extensor/flexor and elbow extensor/flexor as determined by Biodex
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 weeks of exercise Muscle strength will be evaluated by means of the Biodex
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change from baseline up to 12 weeks
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aerobic capacity as determined by a maximal endurance test on the bike
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 weeks of exercise Aerobic capacity will be tested during a maximal endurance test on the bike
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change from baseline up to 12 weeks
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blood lactate concentrations during exercise as determined by a maximal endurance test on the bike
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 weeks of exercise Lactate concentrations (mmol/L) will be tested during a maximal endurance test on the bike
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change from baseline up to 12 weeks
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heart function
Time Frame: change from baseline up to 12 weeks
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measured at baseline and after 12 and 24 weeks of exercise
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change from baseline up to 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bert O Eijnde, Ph.D., Hasselt University, REVAL/BIOMED
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-CMR
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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