Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy
Condition: Multiple Sclerosis; Healthy Controls
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Physical exercise
Intervention type(s): Behavioral
Other intervention name(s): combined (endurance and resistance) exercise programme
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiometabolic risk; physical exercise