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| Name | Class |
|---|---|
| The German Heart Foundation | OTHER |
| Klinikum rechts der Isar Technische Universität München | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first arm | Experimental | first moderate-intensity exercise, second vigorous-intensity exercise, third short bouts of maximal exercise |
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| second arm | Experimental | first vigorous-intensity exercise, second short bouts of maximal exercise, third moderate-intensity exercise |
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| third arm | Experimental | first short bouts of maximal exercise, second moderate-intensity exercise, third vigorous-intensity exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood leukocyte levels pre- and post-intervention | From enrollment to the end of the last intervention at 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hendrik B Sager, MD | Contact | 00498912184025 | hendrik.sager@tum.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Heart Centre | Recruiting | München | Bavaria | 80636 | Germany |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| 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) |
|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |