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CompletedNCT07237854Updated Nov 20, 2025

Effect of Training Intensity on Microvascular Function

An interventional study of Percutaneous muscle biopsies of the vastus lateralis (quadriceps) and Measurement of the maximal oxygen uptake (VO2max) in Vascular Remodeling, Sedentary Behavior and Hemodynamic Rebound, sponsored by Université Libre de Bruxelles. Completed at 1 site in Belgium. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The aim of this trial is to investigate the effect of aerobic training intensity on muscle vascular function: continuous versus interval.

Read the detailed description

This trial will compare the hemodynamic effects of aerobic training on muscle microvascular function between participants randomly assigned to one of two groups: a continuous training group and an high-intensity interval training group.

All data concerning the primary and secondary outcomes will be obtained at the start and repeated at the end of 8 weeks aerobic training.

02

Conditions studied

  • Vascular Remodeling
  • Sedentary Behavior
  • Hemodynamic Rebound

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Keywords

  • Microcirculation
  • Hemodynamic Instability
  • Microvascular Density
  • Quadriceps Muscle
  • Endurance Training
  • High-Intensity Interval Training
03

In context

Sedentary Behavior

332 studies on the registry are indexed under Sedentary Behavior; 155 are open to participants now.

This study's enrollment of 25 is below the median of 70 across 287 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

Université Libre de Bruxelles is the lead sponsor of 44 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy female or male between 18 and 45 years
  • Be sedentary
  • Able to cycle
  • Able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Have a pathology that may impact vascular function as :

    • cardiac pathology
    • pneumological pathology
    • metabolic pathology
  • Smoke
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Moderate-Intensity Continuous Training (MICT): 34 min at 65% maximal heart rate

    Participants performed a 3-minute warm-up at 50% of their maximal heart rate (HRmax), as determined during baseline cardiopulmonary exercise testing (ergospirometry), followed by 40 minutes of continuous cycling at 65% of their VO₂max. Sessions were conducted three times per week for a total duration of 8 weeks.

    Procedure: Percutaneous muscle biopsies of the vastus lateralis (quadriceps) · Other: Measurement of the maximal oxygen uptake (VO2max) · Other: Non-Invasive Cardiac Output Measurement (Innocor)

  • Experimental
    High-Intensity Interval Training (HIIT): 2x2 min at 65% and 90% of maximal heart rate

    Participants performed a 3-minute warm-up at 50% of their maximal heart rate (HRmax), as determined during baseline cardiopulmonary exercise testing (ergospirometry). The main training protocol consisted of alternating 2-minute cycling bouts: 2 minutes at 65% HRmax followed by 2 minutes at 90% HRmax, repeated continuously for a total of 28 minutes. Sessions were conducted three times per week over an 8-week period.

    Procedure: Percutaneous muscle biopsies of the vastus lateralis (quadriceps) · Other: Measurement of the maximal oxygen uptake (VO2max) · Other: Non-Invasive Cardiac Output Measurement (Innocor)

Interventions

  • ProcedurePercutaneous muscle biopsies of the vastus lateralis (quadriceps)

    Percutaneous muscle biopsies of the vastus lateralis (quadriceps) were performed under local anesthesia. Samples were collected at baseline and/or post-intervention to assess microvascular structure, fiber composition, and molecular adaptations to aerobic training.

  • OtherMeasurement of the maximal oxygen uptake (VO2max)

    Cardiopulmonary Exercise Testing (CPET) Maximal oxygen consumption (VO₂max) was assessed using an incremental stepwise protocol on a cycle ergometer. Participants performed the test at baseline and after the 8-week training intervention. Respiratory gas exchange was continuously measured using a COSMED K5 portable metabolic system, which provided breath-by-breath analysis of oxygen uptake (VO₂), carbon dioxide production (VCO₂), and ventilation parameters. The test was terminated upon volitional exhaustion or when predefined criteria for VO₂max plateau were met.

  • OtherNon-Invasive Cardiac Output Measurement (Innocor)

    Maximal cardiac output was assessed at peak exercise intensity during cardiopulmonary exercise testing (CPET) using the Innocor device. This system employs the inert gas rebreathing technique, which involves the controlled inhalation of a gas mixture containing nitrous oxide (N₂O) and sulfur hexafluoride (SF₆). By analyzing the washout kinetics of these gases during rebreathing, the device estimates pulmonary blood flow, which is then used to calculate cardiac output non-invasively. Measurements were performed at the maximal workload reached during the incremental cycling test.

06

What researchers measure

Primary outcomes

  1. Percutaneous muscle biopsies of the vastus lateralis

    Muscle tissue samples obtained from the vastus lateralis were processed using optical clearing and immunohistochemical staining techniques to visualize the microvascular network. Confocal microscopy was employed to acquire high-resolution three-dimensional images of arterioles, capillaries, and venules. Quantitative assessments included: 1. Internal diameter measurements, based on endothelial cell boundaries (intima layer) 2. External diameter measurements, based on smooth muscle cells and pericytes (media layer) 3. Capillary density, determined by counting the number of capillaries per sample volume

    Time frame: At baseline and after completion of the 8-week intervention

Secondary outcomes

  1. Cardiopulmonary Exercise Testing (CPET)

    VO₂max was determined using a graded, incremental exercise test performed on a cycle ergometer until volitional exhaustion. Throughout the test, respiratory gases were continuously measured using a metabolic cart (e.g., COSMED K5), which provided breath-by-breath analysis. The following parameters were recorded : 1. VO₂ (oxygen uptake) in mL/min 2. VCO₂ (carbon dioxide production) in mL/min 3. Minute ventilation (VE) in L/min

    Time frame: At baseline and after completion of the 8-week intervention

  2. Maximal Cardiac Output Measurement Using Inert Gas Rebreathing (Innocor)

    Innocor is a medical device that estimates cardiac output using the inert gas rebreathing technique, a validated non-invasive method. During the procedure, the participant inhales a gas mixture containing nitrous oxide (N₂O) and sulfur hexafluoride (SF₆) through a closed circuit. These inert gases are absorbed and eliminated at rates proportional to pulmonary blood flow. By analyzing the washout kinetics of these gases during a brief rebreathing period, Innocor calculates pulmonary blood flow, which is then used to estimate cardiac output. This measurement is typically performed at rest or at peak exercise intensity, such as during the final stage of a cardiopulmonary exercise test (CPET). The system provides real-time data on: 1. Cardiac output (L/min) 2. Stroke volume (ml/min) 3. Heart rate (bpm) 4. Pulmonary blood flow (L/min)

    Time frame: At baseline and after completion of the 8-week intervention

07

Study locations

1 site
  • Université Libre de Bruxelles, Faculté des Sciences de la motricité, Laboratoire de kinésithérapie
    Brussels, Anderlecht 1070, Belgium
08

References and documents

Publications

  • Maufroy E, Rigaut C, Maufroy C, Baeyens N, Deboeck G. Vascular remodeling enhances high-flow muscle oxygen delivery following aerobic exercise training. Front Physiol. 2026 Jul 1;17:1840439. doi: 10.3389/fphys.2026.1840439. eCollection 2026. PubMed 42460304 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07237854
Lead sponsor
Université Libre de Bruxelles
Responsible party
Emilie Maufroy (Research Scientist, Reasearch Unit in Rehabilitation Sciences, Université Libre de Bruxelles) — Principal investigator
First posted
Nov 20, 2025
Start date
Jan 22, 2022
Primary completion
Aug 15, 2024
Completion
Dec 31, 2024
Last update
Nov 20, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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