InflammationInflExNCT07543666
The ISAR InflEx Trial (Inflammation and Exercise)
A study testing moderate-intensity exercise, vigorous-intensity exercise and short bouts of maximal exercise in people with Inflammation and Obesity (Disorder), run by Department of Cardiology German Heart Center Munich TUM University Hospital at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Inflammation, Obesity (Disorder)
- What is being tested?
- moderate-intensity exercise, vigorous-intensity exercise and short bouts of maximal exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- any acute or chronic illness
- pregnancy and breastfeeding
- active smoking
- Regular use of medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
German Heart Centre
München, Bavaria, 80636
Hendrik B Sager, MD, 00498912184025, hendrik.sager@tum.de
About this study
Official title: Impact of Different Exercise Intensities and Durations on Systemic Inflammation - 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.
Read the detailed description
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.
- Conditions
- Inflammation, Obesity (Disorder)
- Being tested
- moderate-intensity exercise, vigorous-intensity exercise, short bouts of maximal exercise
- Keywords
- exercise, inflammation, obesity, physical activity
- Medical subject headings
- Inflammation, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate-intensity exerciseProcedure or surgery
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 exerciseProcedure or surgery
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 exerciseProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| first arm | Experimental | first moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise Receives: Procedure: moderate-intensity exercise; Procedure: vigorous-intensity exercise; Procedure: short bouts of maximal exercise |
| second arm | Experimental | first vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise Receives: Procedure: moderate-intensity exercise; Procedure: vigorous-intensity exercise; Procedure: short bouts of maximal exercise |
| third arm | Experimental | first short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise Receives: Procedure: moderate-intensity exercise; Procedure: vigorous-intensity exercise; Procedure: short bouts of maximal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood leukocyte levels pre- and post-intervention
Measured: From enrollment to the end of the last intervention at 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Cardiology German Heart Center Munich TUM University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation, Technical University of Munich
- Responsible party
- Principal investigator, Hendrik Sager, Department of Cardiology German Heart Center Munich TUM University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543666
- Sponsor's protocol ID
- 2024-656-S-CB
- Acronym
- InflEx
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Exercise Intensities and Durations on Systemic Inflammation - The ISAR InflEx Trial (Inflammation and Exercise) -
- ClinicalTrials.gov ID
- NCT07543666
- Acronym / sponsor ID
- InflEx / 2024-656-S-CB
- Conditions
- Inflammation, Obesity (Disorder)
- Keywords
- exercise, inflammation, obesity, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Department of Cardiology German Heart Center Munich TUM University HospitalUniversity, hospital or other
- Collaborators
- The German Heart Foundation, Technical University of Munich
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| first arm | Experimental | Procedure: moderate-intensity exercise, Procedure: vigorous-intensity exercise, Procedure: short bouts of maximal exercisefirst moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise |
| second arm | Experimental | Procedure: moderate-intensity exercise, Procedure: vigorous-intensity exercise, Procedure: short bouts of maximal exercisefirst vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise |
| third arm | Experimental | Procedure: moderate-intensity exercise, Procedure: vigorous-intensity exercise, Procedure: short bouts of maximal exercisefirst short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- any acute or chronic illness
- pregnancy and breastfeeding
- active smoking
- Regular use of medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate-intensity exerciseGuideline recommended 150 min/week of moderate-intensity aerobic physical exercise (40-50% VO2peak) on 5 days per week (30 min per session) | Procedure or surgery | first arm, second arm, third arm |
| vigorous-intensity exerciseGuideline recommended 75 min/week of vigorous-intensity physical exercise (70-80% VO2peak) on 5 days per week (15 min per session) | Procedure or surgery | first arm, second arm, third arm |
| short bouts of maximal exerciseMaximal 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) | Procedure or surgery | first arm, second arm, third arm |
Primary outcome
Changes in blood leukocyte levels pre- and post-intervention
Time frame: From enrollment to the end of the last intervention at 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate-intensity exercise, vigorous-intensity exercise and short bouts of maximal exercise in people with Inflammation and Obesity (Disorder), run by Department of Cardiology German Heart Center Munich TUM University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hendrik B Sager, MD (00498912184025, hendrik.sager@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood leukocyte levels pre- and post-intervention (time frame: From enrollment to the end of the last intervention at 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.