NIRS and Exercise Intensity in Patients With FLIA

NCT05229250 | Terminated

• 1 other identifier: NL79767.015.21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Near-Infrared Spectroscopy; Iliac Artery Stenosis; Iliac Artery Disease; Iliac Artery Occlusion

Keywords

FLIA; NIRS; Endofibrosis

Outcome Measures

Primary Outcomes (17)

• Power-deoxygenation (PD) profile

  Power-deoxygenation (PD) profile: The ratio of power output to deoxygenation (eg. power/deoxy\[heme\]) as a proxy for the metabolic disturbance at the working muscle relative to the workload.

  During cyclingtest day 1

• Near Infrared Spectroscopy (NIRS) deoxygenation parameters

  Baseline: Average 60-second value before the start of exercise. min: the minimum 5-second mean value attained during exercise. max: the maximum 5-second mean value attained typically during the recovery after exercise. Δexercise amplitude: the difference between baseline and minimum values.

  During cyclingtest day 1

• Near Infrared Spectroscopy (NIRS) deoxygenation parameters

  Baseline: Average 60-second value before the start of exercise. min: the minimum 5-second mean value attained during exercise. max: the maximum 5-second mean value attained typically during the recovery after exercise. Δexercise amplitude: the difference between baseline and minimum values.

  During cyclingtest day 2

• NIRS delta_recovery amplitude

  The difference between minimum and maximum value.

  During cyclingtest day 1

• NIRS delta_recovery amplitude

  The difference between minimum and maximum value.

  During cyclingtest day 2

• NIRS reoxygenation kinetics: tau

  Time constant (tau, in seconds): the time constant parameter of a monoexponential curve fit to the reoxygenation profile after each work stage.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: Time delay

  Time delay (TD, in seconds): the delay before systematic rise in oxygenation after each work stage.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: Mean Response Time

  Mean response time (MRT, in seconds): the sum of TD and tau.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: Half value time

  Half value recovery time (HVT, in seconds): the time required to reoxygenate half of the total amplitude during recovery after each work stage.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: Peak reoxygenation rate

  Peak reoxygenation rate (SmO2/sec): a linear estimation of the peak resaturation slope, representing the magnitude of greatest mismatch between oxygen supply and utilization at the tissue during recovery kinetics, after each work stage.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: Peak reoxygenation MRT

  Peak reoxygenation MRT: an estimate of the time to occurrence of the peak reoxygenation rate, analogous to the MRT in a monoexponential curve, and representing the balance of recovery kinetics of oxygen supply and utilization in the tissue after each work stage.

  Immediately after exercise day 1

• NIRS reoxygenation kinetics: tau

  Time constant (tau, in seconds): the time constant parameter of a monoexponential curve fit to the reoxygenation profile after each work stage.

  Immediately after exercise day 2

• NIRS reoxygenation kinetics: Time delay

  Time delay (TD, in seconds): the delay before systematic rise in oxygenation after each work stage.

  Immediately after exercise day 2

• NIRS reoxygenation kinetics: Mean response time

  Mean response time (MRT, in seconds): the sum of TD and tau.

  Immediately after exercise day 2

• NIRS reoxygenation kinetics: Half Value time

  Half value recovery time (HVT, in seconds): the time required to reoxygenate half of the total amplitude during recovery after each work stage.

  Immediately after exercise day 2

• NIRS reoxygenation kinetics: Peak reoxygenation rate

  Peak reoxygenation rate (SmO2/sec): a linear estimation of the peak resaturation slope, representing the magnitude of greatest mismatch between oxygen supply and utilization at the tissue during recovery kinetics, after each work stage.

  Immediately after exercise day 2

• NIRS reoxygenation kinetics: Peak reoxygenation MRT

  Peak reoxygenation MRT: an estimate of the time to occurrence of the peak reoxygenation rate, analogous to the MRT in a monoexponential curve, and representing the balance of recovery kinetics of oxygen supply and utilization in the tissue after each work stage.

  Immediately after exercise day 2

Secondary Outcomes (12)

• Recovery kinetics VO2/NIRS comparison

  After stages/maximal exercise. This is an offline analyses and therefore takes the time of the stage (1 minute for in between blocks; 5 minutes for maximal exercise)

• Vascular Occlusion Test - Reactive Hyperemia Area Under The Curve

  Before cycling test day 1

• Multiple reoxygenation kinetics - Primary Component Time constant tau

  Between intervention day 1 (1-minute stages of block-protocol) and immediately after the intervention day 2 (ramp maximal test)

• Multiple reoxygenation kinetics - Cardiodynamic component time delay

  Between intervention day 1 (1 minustages of block-protocol) and immediately after the intervention day 2 (ramp maximal test)

• Multiple reoxygenation kinetics - Δdeoxy[heme] / ΔVO2 onset kinetics

  During intervention day 1 (stages of block-protocol)

Study Arms (2)

Healthy subjects

Subjects without FLIA

Other: Cycling test; Other: Occlusion tests; Device: NIRS during cycling; Device: CPET; Device: Echo-Doppler examination

Patient subjects

Subjects with FLIA

Other: Cycling test; Other: Occlusion tests; Device: NIRS during cycling; Device: CPET; Device: Echo-Doppler examination

Interventions

Occlusion tests OTHER

Occlusion test before and after exercise

Healthy subjects; Patient subjects

NIRS during cycling DEVICE

NIRS devices measuring oxygenation during exercise

Healthy subjects; Patient subjects

CPET DEVICE

Cardiopulmonary exercise testing (heart rate, pulmonary gas exchange) during exercise

Healthy subjects; Patient subjects

Echo-Doppler examination DEVICE

Peak systolic velocity and vascular stiffness measurements in the iliac-aortic tract

Healthy subjects; Patient subjects

Cycling test OTHER

RAMP and MULTI-STAGE test

Healthy subjects; Patient subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited after the diagnosis of FLIA is given during weekly standard clinical care. Healthy subjects will be recruited from local cycling clubs. They completed a standardized questionnaire excluding presence of risk factors such as smoking and positive cardiovascular family history. Candidates with FLIA were excluded. Candidates who fulfilled all study criteria, served as the control group

You may qualify if:

• Aged ≥ 18 years and ≤ 40 years
• Trained cyclist or triathlete regularly training at least \~3/week for at least five years and identifying with a particular cycle-sport

You may not qualify if:

• Earlier vascular iliac surgery
• Microvascular abnormalities (e.g. diabetes),
• Vascular abnormalities outside of the iliac region,
• Heart failure (New York Heart Association class \>I),
• Orthopedic/neurological entities potentially limiting exercise capacity,
• Obesity.
• Adipose tissue thickness \> 7.5 mm
• These excluding conditions are considered as medical safety precautions to maximal exercise or as risk of unexpected pathophysiological effects confounding our primary outcome measures.
• It is known that a high level of adipose tissue thickness (ATT) influences the accuracy of NIRS measurement of underlying muscular tissue. A \> 7.5 mm ATT cut-off point at the site of NIRS measurement determined with a skinfold caliper (Harpenden, Baty International West Sussex, UK) was chosen. The ATT is calculated as half the skinfold thickness.

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Maxima MC

Veldhoven, North Brabant, 4600, Netherlands

Location

Related Publications (26)

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Study Officials

• M van Hooff, MSc

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: February 8, 2022
• Study Start: August 24, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)