NCT05229250

NIRS and Exercise Intensity in Patients With FLIA

Terminated Last updated 14 January 2026

What this trial tests

trial testing Cycling test in Near-Infrared Spectroscopy in 60 participants. Terminated before completion.

Timeline

24 August 2022

Primary endpoint
1 May 2023

1 December 2023

Quick facts

Lead sponsor	Maxima Medical Center
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	60
Start date	24 August 2022
Primary completion	1 May 2023
Estimated completion	1 December 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Cycling test
• Occlusion tests
• NIRS during cycling
• CPET
• Echo-Doppler examination

Conditions studied

• Near-Infrared Spectroscopy — all drugs for Near-Infrared Spectroscopy →
• Iliac Artery Stenosis — all drugs for Iliac Artery Stenosis →
• Iliac Artery Disease — all drugs for Iliac Artery Disease →
• Iliac Artery Occlusion — all drugs for Iliac Artery Occlusion →

Sponsor

Maxima Medical Center

Who can join

Adults 18 to 40, any sex, with Near-Infrared Spectroscopy or Iliac Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The research objectives of this project are to increase the understanding of pathophysiology and performance limitations related to sport-related flow limitation in the iliac artery (FLIA) using non-invasive measurement of muscle oxygenation at the working muscles of the leg and mechanical power output recorded during cycling exercise. Skeletal muscle oxygenation measured with Near-Infrared Spectroscopy (NIRS) is growing more accessible for use by coaches, teams, and individual athletes for use in performance testing. Describing how muscle oxygenation profiles in endurance athletes diagnosed with FLIA differ in comparison with healthy athletes may allow the use of this non-invasive, accessible measurement device for the screening of athletes at risk of developing FLIA.

The relevance of this work is that FLIA imposes risk of irreversible injury to the main artery of the leg in endurance athletes, limiting their ability to participate in exercise, with further consequences for health, fitness, and quality of life. Currently, the early course of this progressive condition is poorly understood, as early detection is difficult and hence appropriate treatment is often delayed. If impairment becomes severe, often more invasive (and risky) treatment is necessary. Earlier detection and monitoring of FLIA may allow for improved patient management and outcomes.

The design of this experiment will compare a patient group of trained cyclists diagnosed with FLIA, to healthy control subjects including cyclists of a similar fitness level without signs of FLIA. Both groups will perform an incremental ramp cycling test and an intermittent multi-stage cycling exercise test. Incremental ramp cycling testing is used as part of clinical diagnosis of FLIA, as well as performance (eg. VO2max) testing of healthy athletes. Multi-stage exercise protocols are also often used for performance testing of endurance athletes and allows for observation of (path)physiological responses during submaximal work stages. Outcome measures of muscle oxygenation kinetics with NIRS and cycling power will be analysed and compared between patients and healthy subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.