NCT07543666

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Jun 2027

Study Start

First participant enrolled

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 15, 2026

Last Update Submit

April 21, 2026

Conditions

Obesity (Disorder)Inflammation

Keywords

exerciseinflammationobesityphysical activity

Outcome Measures

Primary Outcomes (1)

  • Changes in blood leukocyte levels pre- and post-intervention

    From enrollment to the end of the last intervention at 15 weeks

Study Arms (3)

first arm

EXPERIMENTAL

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

Procedure: moderate-intensity exerciseProcedure: vigorous-intensity exerciseProcedure: short bouts of maximal exercise

second arm

EXPERIMENTAL

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

Procedure: moderate-intensity exerciseProcedure: vigorous-intensity exerciseProcedure: short bouts of maximal exercise

third arm

EXPERIMENTAL

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

Procedure: moderate-intensity exerciseProcedure: vigorous-intensity exerciseProcedure: short bouts of maximal exercise

Interventions

moderate-intensity exercisePROCEDURE

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

first armsecond armthird arm
vigorous-intensity exercisePROCEDURE

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

first armsecond armthird arm
short bouts of maximal exercisePROCEDURE

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)

first armsecond armthird arm

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Centre

München, Bavaria, 80636, Germany

RECRUITING

MeSH Terms

Conditions

InflammationObesityMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsBehavior

Central Study Contacts

Hendrik B Sager, MD

CONTACT

00498912184025hendrik.sager@tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Hendrik Sager

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

DE(1)