Non-invasive MSOT Examination of Muscle Oxygenation in Athletes and PAD Patients

Official title

Non-invasive Assessment of Skeletal Muscle Oxygenation in Athletes and Patients With Peripheral Arterial Disease Using Multispectral Optoacoustic Tomography During Standardized Physical Exercise

Overview

The aim of the study is to present the quantitative differences in oxygenated hemoglobin in different cohorts. This clinical study evaluates whether there is a correlation between measurements using multispectral optoacoustic tomography and the results of spiroergometry in the context of performance diagnostics.

Detailed description

This study aims to investigate the muscle metabolism of athletes (endurance and strength athletes), PAD patients, and healthy control subjects using non-invasive multispectral optoacoustic tomography as part of interval treadmill spiroergometry. The aim is to take a closer look at changes in oxygen supply and muscle metabolism in the various patient groups during the recovery phase. To this end, the individual groups will perform a performance diagnosis on a treadmill spiroergometer, adapted to their respective estimated physical performance (in the case of PAD patients, taking into account the possibilities given by the disease), which will be carried out in the form of a step test. In addition, MSOT measurements will be taken between the individual steps.

The aim of this study is to use MSOT to visualize and compare the muscle perfusion-in particular the proportion of oxygenated and deoxygenated hemoglobin (Hb)-of the various cohorts, as well as to compare it with the diagnostics and methods commonly used to date and identify any advantages. In the future, this could contribute to a better understanding of muscle perfusion, especially in connection with diseases such as PAD or other muscle lesions in sports medicine.

Interventions

• Diagnostic test MSOT - Multispectral optoacustic tomography
  MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, w
• Diagnostic test CPET
  Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload. It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful i

Primary outcome measures

• Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography [Time frame: through study completion, an average of 1 year]
• Peak oxygen uptake (VO₂peak): VO₂peak (mL·kg-¹·min-¹) [Time frame: through study completion, an average of 1 year]
• Respiratory exchange ratio (RER): RER (VCO₂/VO₂, unitless) [Time frame: Through study completion, average of 1 year]
• Minute ventilation: Ventilation (L·min-¹) [Time frame: Through study completion, average of 1 year]
• Carbon dioxide production (VCO₂): VCO₂ (mL·min-¹) [Time frame: Through study completion, average of 1 year]
• Heart rate response to exercise: Heart rate (bpm) [Time frame: Through study completion, average of 1 year]
• Absolute oxygen consumption: VO₂ (mL·min-¹) [Time frame: Through study completion, average of 1 year]
• Anaerobic threshold: HR or workload at AT unit: bpm or km/h [Time frame: Through study completion, average of 1 year]
• Breathing reserve; Percentage (%) [Time frame: Through study completion (an average of 1 year)]
• Ventilatory equivalent for oxygen (VE/VO₂): Unitless [Time frame: Through study completion (an average of 1 year)]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years (adults capable of giving consent)
• Capacity to consent. The subjects are able to understand the information provided and give their written consent.
• Belonging to one of the following cohorts:
• Endurance athletes: at least 3× per week ≥ 60 minutes of intensive endurance training (e.g., running, cycling, swimming)
• Strength athletes: at least 3× per week ≥ 60 minutes of intensive strength training without additional endurance training
• Healthy control subjects: less than 2× per week < 30 minutes of physical activity, no known vascular diseases
• PAD patients: diagnosed peripheral arterial occlusive disease in Fontaine stage I or IIa Women of childbearing age with or without contraception may participate, as there are no risks of harm to the fetus.
• Consent to pseudonymized data collection and storage in accordance with the GDPR.

Exclusion criteria

• Age over 75 years
• Minors (Age < 18)
• safety concerns on the part of the study physician, e.g., in the case of of: physical, mental or psychiatric illnesses, acute or chronic conditions that could jeopardise safety or data quality
• Taking medications that could affect physical performance or physiological measurements (e.g., heart rate, oxygen uptake).
• Pregnancy with known risks or complications (participation is possible in principle, but subject to individual medical review).
• Refusal to participate or lack of informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07347535 · MSOT_SPO2RT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗