- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237854
Effect of Training Intensity on Microvascular Function
Effect of Continuous Versus High-intensity Interval Aerobic Training on the Muscular Vascular Adaptation
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anderlecht
-
Brussels, Anderlecht, Belgium, 1070
- Université Libre de Bruxelles, Faculté des Sciences de la motricité, Laboratoire de kinésithérapie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy female or male between 18 and 45 years
- Be sedentary
- Able to cycle
- Able to provide written informed consent
Exclusion Criteria:
Have a pathology that may impact vascular function as :
- cardiac pathology
- pneumological pathology
- metabolic pathology
- Smoke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
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.
|
|
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percutaneous muscle biopsies of the vastus lateralis
Time Frame: At baseline and after completion of the 8-week intervention
|
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:
|
At baseline and after completion of the 8-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiopulmonary Exercise Testing (CPET)
Time Frame: At baseline and after completion of the 8-week intervention
|
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 :
|
At baseline and after completion of the 8-week intervention
|
|
Maximal Cardiac Output Measurement Using Inert Gas Rebreathing (Innocor)
Time Frame: At baseline and after completion of the 8-week intervention
|
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:
|
At baseline and after completion of the 8-week intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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