NCT07237854

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

September 26, 2022

Last Update Submit

November 14, 2025

Conditions

Keywords

MicrocirculationHemodynamic InstabilityMicrovascular DensityQuadriceps MuscleEndurance TrainingHigh-Intensity Interval Training

Outcome Measures

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

    At baseline and after completion of the 8-week intervention

Secondary Outcomes (2)

  • Cardiopulmonary Exercise Testing (CPET)

    At baseline and after completion of the 8-week intervention

  • Maximal Cardiac Output Measurement Using Inert Gas Rebreathing (Innocor)

    At baseline and after completion of the 8-week intervention

Study Arms (2)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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

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.

High-Intensity Interval Training (HIIT): 2x2 min at 65% and 90% of maximal heart rateModerate-Intensity Continuous Training (MICT): 34 min at 65% maximal heart rate

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.

High-Intensity Interval Training (HIIT): 2x2 min at 65% and 90% of maximal heart rateModerate-Intensity Continuous Training (MICT): 34 min at 65% maximal heart rate

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.

High-Intensity Interval Training (HIIT): 2x2 min at 65% and 90% of maximal heart rateModerate-Intensity Continuous Training (MICT): 34 min at 65% maximal heart rate

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Have a pathology that may impact vascular function as :
  • cardiac pathology
  • pneumological pathology
  • metabolic pathology
  • Smoke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Libre de Bruxelles, Faculté des Sciences de la motricité, Laboratoire de kinésithérapie

Brussels, Anderlecht, 1070, Belgium

Location

MeSH Terms

Conditions

Vascular RemodelingSedentary Behavior

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic ProcessesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and the researcher will know the group allocation and therfore cannot be blinded.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A parallel group randomised controlled trial will be used to determine the superiority of high-intensity interval training versus continuous training on the improvement of quadricpes microvascular function.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Reasearch Unit in Rehabilitation Sciences

Study Record Dates

First Submitted

September 26, 2022

First Posted

November 20, 2025

Study Start

January 22, 2022

Primary Completion

August 15, 2024

Study Completion

December 31, 2024

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations