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临床试验/NCT02466165
NCT02466165已完成不适用

Multiple Sclerosis: Associated Cardiometabolic Risks and Impact of Exercise Therapy

Bert Op't Eijnde4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
4
主要终点
hypertension / blood pressure as determined by supine blood pressure measures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy controls:
  • male/female
  • 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

排除标准

  • 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

结局指标

主要结局

hypertension / blood pressure as determined by supine blood pressure measures

时间窗: change from baseline up to 12 weeks

measured at baseline and after 12 of exercise Blood pressure will be evaluated supine.

inflammation as determined by analysis of blood samples

时间窗: 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)

body fat as determined by DEXA scan

时间窗: 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.

glucose tolerance / insulin resistance as determined by oral glucose tolerance test

时间窗: 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

dyslipidemia, as determined by the analysis of blood samples

时间窗: 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.

次要结局

  • 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)
  • heart function(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)

研究者

发起方
Bert Op't Eijnde
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bert Op't Eijnde

PhD

Hasselt University

研究点 (4)

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