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临床试验/NCT03919058
NCT03919058已完成不适用

Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis

Hasselt University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年4月13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
28
试验地点
2
主要终点
Standing time

研究概览

简要总结

This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.

详细描述

To date, it is clear that sedentary behaviour is strongly related to an increased risk of type II diabetes, cardiovascular disease and premature mortality. People suffering from chronic disabilities appear to be particularly susceptible to a sedentary lifestyle and inactivity due to primary disease symptoms. To date, this is an important new research topic in Multiple Sclerosis (MS, ~2.3 million people worldwide, ~10-12.000 diagnosed in Belgium) treatment, since previous research reported a significantly higher prevalence of sedentary behaviour in persons with MS (PwMS) compared to healthy controls (HC). PwMS are reported to have a 40% lower daily step count compared to healthy inactive persons and tend to accumulate their sedentary time in longer bouts. As described above and similar to other chronic conditions, a sedentary lifestyle also makes PwMS more vulnerable to the accumulation of important cardiometabolic comorbidities that seem inactivity-related rather than a direct result of non-reversible tissue injury. Such comorbidities include impaired whole body glycaemic control, an abnormal blood lipid profile, an unhealthy body composition and hypertension. In this respect, it is important to note that corticosteroids, which are often used to treat MS patients pharmacologically, elevate fasting glucose and insulin concentrations and induce insulin resistance in HC therefore probably also increase several cardiometabolic risk factors in MS.

Up to now, research in MS has been focused on structured exercise and its positive effects on functional parameters are well-known (e.g. improvements in cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life and respiratory function). However, evidence is growing that sedentary time, independent of the (dis)practice of structured exercise, is an important independent health risk factor. Consequently, any strategy that also improves cardiometabolic health may help to further optimize rehabilitation in MS. Breaking up and reducing sedentary time with easy, daily activities such as household activities and other activities which increase light-intensity walking and standing, known as non-exercise physical activity (NEPA) may be such a strategy.

NEPA has already been shown to significantly improve cardiometabolic risk markers in healthy, sedentary subjects, type II diabetes patients and obese adults and it involves lower intensity physical activities that are probably more feasible for PwMS. Moreover, with comparable activity workloads, reducing sitting time by NEPA of longer duration decreases insulin levels and fasting lipid levels more than performing one structured exercise bout of moderate intensity that is usually described in current activity guidelines. So far however, acute exercise bouts and NEPA effects on cardiometabolic health in this population have never been described. Therefore, the aim of this study is to investigate whether (1) cardiometabolic health (glycaemic control, blood lipids, inflammation markers and blood pressure) of persons with MS improves when sedentary time is reduced and (2) NEPA results in better cardiometabolic health parameters than (a shorter daily bout of) moderate-intensity exercise when workload of both activities is identical in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will not know the code of the different regimes.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Men and women ≥18 years old
  • Clinical diagnosis of MS (McDonald criteria)
  • Expanded Disability Status Score ≤ 5
  • Daily internet access

排除标准

  • Reported participation in another biomedical trial which may have an effect on blood parameters one month before the pre-study examination or during the study
  • Blood donation in the past three months
  • Pregnancy or intention of becoming pregnant
  • Reported dietary habits: medically prescribed diet, slimming diet
  • Reported weight loss (>2kg) in the last three months prior to the screening
  • Alcohol use > 20 units per week (during the last 3 months)
  • Experimental drug use (during the last 3 months)
  • Medication changes (during the last month)
  • Medical conditions which make participation in the study not responsible:
  • Heart failure: New York Heart Association (NYHA) 3 or higher
  • Angina pectoris or signs of cardiac ischemia during exercise testing
  • Mental or physical disability
  • Based on historical information not able to walk for 3h per day and stand for 4h per day (e.g. intermittent claudication)

结局指标

主要结局

Standing time

时间窗: Day 1 to 4 of the Exercise regime

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of interleukin 1 (IL-1)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of glucose

时间窗: Day after the Exercise regime

Blood analysis

Concentration of insulin

时间窗: Day after the Exercise regime

Blood analysis

Steps per day

时间窗: Day 1 to 4 of the Exercise regime

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Concentration of apolipoprotein A1 (apo A1)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of apolipoprotein B (apo B)

时间窗: Day after the Exercise regime

Blood analysis

Sitting time

时间窗: Day 1 to 4 of the Exercise regime

Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Concentration of free fatty acids (FFA)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of C-reactive protein (CRP)

时间窗: Day after the Exercise regime

Blood analysis

Stepping time

时间窗: Day 1 to 4 of the Exercise regime

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Concentration of total cholesterol

时间窗: Day after the Exercise regime

Blood analysis

Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

时间窗: Day after the Exercise regime

Blood analysis

Concentration of triglyceride

时间窗: Day after the Exercise regime

Blood analysis

Concentration of interleukin 6 (IL-6)

时间窗: Day after the Exercise regime

Blood analysis

次要结局

  • Body weight(Day after the Exercise regime)
  • Blood pressure(Day after the Exercise regime)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bert Op't Eijnde

Prof. dr. Bert Op't Eijnde

Hasselt University

研究点 (2)

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