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NCT Number: NCT07543666

The ISAR InflEx Trial (Inflammation and Exercise)

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Heart Centre

München, Bavaria, 80636, Germany

Location status: Recruiting

Location contact

Hendrik B Sager, MD

CONTACT

[email protected]

00498912184025

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

moderate-intensity exercise

Procedure

Guideline recommended 150 min/week of moderate-intensity aerobic physical exercise (40-50% VO2peak) on 5 days per week (30 min per session)

vigorous-intensity exercise

Procedure

Guideline recommended 75 min/week of vigorous-intensity physical exercise (70-80% VO2peak) on 5 days per week (15 min per session)

short bouts of maximal exercise

Procedure

Maximal vigorous-intensity physical exercise for 1 minute twice per day (>90% VO2peak) on 5 days per week (1 min per session, total of 2 min per day)

Primary outcomes

  1. Changes in blood leukocyte levels pre- and post-intervention

    Time frame: From enrollment to the end of the last intervention at 15 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Hendrik B Sager, MD

CONTACT

[email protected]

00498912184025

Sponsors and collaborators

Lead sponsor

Department of Cardiology German Heart Center Munich TUM University Hospital

Other

Collaborators

  • Klinikum rechts der Isar Technische Universität München
  • The German Heart Foundation

Registry information

Official study title

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

Acronym: InflEx

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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