Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

NCT02466165 | Completed DMC

• 1 other identifier: MS-CMR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Multiple Sclerosis; Healthy Controls

Keywords

cardiometabolic risk; physical exercise

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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

  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)

  change from baseline up to 12 weeks

Secondary Outcomes (4)

• muscle strength of knee extensor/flexor and elbow extensor/flexor as determined by Biodex

  change from baseline up to 12 weeks

• aerobic capacity as determined by 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

  change from baseline up to 12 weeks

• heart function

  change from baseline up to 12 weeks

Study Arms (3)

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.

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.

Interventions

Physical exercise BEHAVIORAL

Also known as: combined (endurance and resistance) exercise programme

MS patients intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy controls:
• male/female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bert Op't Eijnde: lead

Study Sites (2)

REVAL

Diepenbeek, 3590, Belgium

Location

Jessa hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bert O Eijnde, Ph.D.

  Hasselt University, REVAL/BIOMED

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: June 9, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

BE (2)