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临床试验/NCT07543666
NCT07543666招募中不适用

Impact of Different Exercise Intensities and Durations on Systemic Inflammation - The ISAR InflEx Trial (Inflammation and Exercise) -

Department of Cardiology German Heart Center Munich TUM University Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
33
试验地点
1
主要终点
Changes in blood leukocyte levels pre- and post-intervention

研究概览

简要总结

A sedentary lifestyle and obesity are associated with chronic low-grade inflammation and an elevated risk of cardiovascular disease (CVD). This study aims to systematically characterize and compare the effects of three distinct exercise modalities - moderate-intensity, vigorous-intensity, and short-duration maximal exercise - each differing in duration and intensity, on systemic inflammation and immune function. The study investigates the potential of exercise as an effective anti-inflammatory intervention for the prevention of CVD.

详细描述

Adverse lifestyle behaviors, particularly sedentary habits, exacerbate inflammation and maladaptive immune responses, thereby promoting vascular inflammation and the development of atherosclerotic cardiovascular disease. Conversely, adopting healthier behaviors, including regular physical activity, may mitigate these effects, improve overall well-being, and prevent the progression from health to disease.

The ISAR InflEx trial aims to systematically evaluate the anti-inflammatory effects of physical exercise on systemic immunity. Healthy volunteers with a BMI of 25.0-30.0 kg/m² who lead a sedentary lifestyle and do not engage in any structured exercise will be enrolled in an exercise intervention.

The first group (n = 11 participants) will begin with a two-week period of moderate-intensity exercise, followed by a three-week break. This will be followed by two weeks of vigorous-intensity exercise, again followed by a three-week break, and finally two weeks of short bouts of maximal-intensity exercise.

The second and third groups (n = 11 each) will undergo the same procedure but in different sequences, starting with vigorous-intensity exercise and short bouts of maximal-intensity exercise, respectively. Blood samples will be collected before each exercise intervention, midway through the intervention, and after its completion to characterize and compare the systemic immune response. The primary outcome measure will be changes in blood leukocyte counts before and after each intervention. Participants will serve as their own controls, with pre-intervention measurements used as baseline values.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25.0 - 30.0 kg/m²
  • age 18 - 45 years
  • informed consent
  • no regular physical activity (≤1x/week of structured exercise)
  • willingness to strictly follow and adhere to the intervention protocol for the entire study

排除标准

  • any acute or chronic illness
  • pregnancy and breastfeeding
  • active smoking
  • Regular use of medication

研究组 & 干预措施

first arm

Experimental

first moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise

干预措施: moderate-intensity exercise (Procedure)

first arm

Experimental

first moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise

干预措施: vigorous-intensity exercise (Procedure)

first arm

Experimental

first moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise

干预措施: short bouts of maximal exercise (Procedure)

second arm

Experimental

first vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise

干预措施: moderate-intensity exercise (Procedure)

second arm

Experimental

first vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise

干预措施: vigorous-intensity exercise (Procedure)

second arm

Experimental

first vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise

干预措施: short bouts of maximal exercise (Procedure)

third arm

Experimental

first short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise

干预措施: moderate-intensity exercise (Procedure)

third arm

Experimental

first short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise

干预措施: vigorous-intensity exercise (Procedure)

third arm

Experimental

first short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise

干预措施: short bouts of maximal exercise (Procedure)

结局指标

主要结局

Changes in blood leukocyte levels pre- and post-intervention

时间窗: From enrollment to the end of the last intervention at 15 weeks

次要结局

未报告次要终点

研究者

发起方
Department of Cardiology German Heart Center Munich TUM University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hendrik Sager

Prof. Dr. med. Hendrik Sager

Department of Cardiology German Heart Center Munich TUM University Hospital

研究点 (1)

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