Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

Multiple Sclerosis Clinical Trial

Official title:

Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466165
• Other study ID #: MS-CMR
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: June 19, 2017
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Controls
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Physical exercise

Locations

Country	Name	City	State
Belgium	REVAL	Diepenbeek
Belgium	Jessa hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Bert Op't Eijnde

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	change from baseline up to 12 weeks
Secondary	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	change from baseline up to 12 weeks
Secondary	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	change from baseline up to 12 weeks
Secondary	heart function	measured at baseline and after 12 and 24 weeks of exercise	change from baseline up to 12 weeks