The ISAR InflEx Trial (Inflammation and Exercise)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDepartment of Cardiology German Heart Center Munich TUM University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI 25.0 - 30.0 kg/m²
age 18 - 45 years
informed consent
no regular physical activity (≤1x/week of structured exercise)
Disqualifiers
any acute or chronic illness
pregnancy and breastfeeding
active smoking
Regular use of medication
Trial design
Design model
Sequential
Treatments tested in this trial
moderate-intensity exercise
Procedure/SurgeryGuideline 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/SurgeryGuideline 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/SurgeryMaximal 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)
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: first armExperimental treatment 3 interventions
Group B: second armExperimental treatment 3 interventions
Group C: third armExperimental treatment 3 interventions
Trial outcomes
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Department of Cardiology German Heart Center Munich TUM University Hospital
Lead sponsor
The German Heart Foundation
Collaborator
Klinikum rechts der Isar Technische Universität München
Collaborator
Source ClinicalTrials.gov