Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

June 19, 2017 updated by: Bert Op't Eijnde
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.

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.

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

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.
80

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

  • Belgium
      • Diepenbeek, Belgium, 3590
        • REVAL
      • Hasselt, Belgium, 3500
        • Jessa Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: Non-Randomized
  • 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: 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.
Behavioral: Physical exercise
Other Names:
  • combined (endurance and resistance) exercise programme
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.
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.

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
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.
change from baseline up to 12 weeks
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.
change from baseline up to 12 weeks
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.
change from baseline up to 12 weeks
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
change from baseline up to 12 weeks
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)
change from baseline up to 12 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
muscle strength of knee extensor/flexor and elbow extensor/flexor as determined by Biodex
Time Frame: change from baseline up to 12 weeks
measured at baseline and after 12 weeks of exercise Muscle strength will be evaluated by means of the Biodex
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
measured at baseline and after 12 weeks of exercise Aerobic capacity will be tested during a maximal endurance test on the bike
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
measured at baseline and after 12 weeks of exercise Lactate concentrations (mmol/L) will be tested during a maximal endurance test on the bike
change from baseline up to 12 weeks
heart function
Time Frame: change from baseline up to 12 weeks
measured at baseline and after 12 and 24 weeks of exercise
change from baseline up to 12 weeks

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.
Bert Op't Eijnde

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bert O Eijnde, Ph.D., Hasselt University, REVAL/BIOMED

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

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.
February 1, 2015

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.
August 1, 2015

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.
December 1, 2015

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).
March 9, 2015

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.
June 4, 2015

First Posted (Estimate)

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.
June 9, 2015

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.
June 20, 2017

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.
June 19, 2017

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.
June 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 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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