Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

CompletedNot a drug-phase studyMS (type not specified)NCT02466165

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Physical exercise

What it measured

Main measures

  • dyslipidemia, as determined by the analysis of blood samples

    change from baseline up to 12 weeks

    Physical function
  • hypertension / blood pressure as determined by supine blood pressure measures

    change from baseline up to 12 weeks

    Physical function
  • body fat as determined by DEXA scan

    change from baseline up to 12 weeks

    Physical function
  • glucose tolerance / insulin resistance as determined by oral glucose tolerance test

    change from baseline up to 12 weeks

    Physical function
  • inflammation as determined by analysis of blood samples

    change from baseline up to 12 weeks

    Physical function

Other measures (4)

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

    change from baseline up to 12 weeks

    Physical function
  • aerobic capacity as determined by a maximal endurance test on the bike

    change from baseline up to 12 weeks

    Physical function
  • blood lactate concentrations during exercise as determined by a maximal endurance test on the bike

    change from baseline up to 12 weeks

    Physical function
  • heart function

    change from baseline up to 12 weeks

    Physical function

Who could take part

MS (type not specified) · 18 to 70 · EDSS 1 to 7

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2015

    2. Main results due

      Aug 2015

    3. Finished

      Dec 2015

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