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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity Hospital Erlangen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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

Disqualifiers

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).

Trial population

The study will include adult participants aged 18 to 75 years, representing different levels of physical activity and vascular health status. A total of approximately 60 participants will be recruited, divided into six cohorts of about ten individuals each. Cohort Description: * Young endurance athletes (≥ 3 times per week, ≥ 60 minutes per session) Examples: running, cycling, swimming * Young strength athletes (≥ 3 times per week, ≥ 60 minutes) No additional endurance training * Young healthy controls Less than 2 times per week and \< 30 minutes of physical activity No known vascular or muscular diseases * Patients with peripheral arterial disease (PAD) Diagnosed with PAD, Fontaine stage I, IIa or IIb * Older inactive controls Age above 55 years, no regular physical activity, no pAVK * Patients with PAD (Fontaine stage I, IIa or IIb, who participate in structured walking training

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MSOT - Multispectral optoacustic tomography

    Diagnostic test

    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, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

  • CPET

    Diagnostic test

    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 in sports medicine, rehabilitation, and clinical diagnostics.

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: PAD - peripheral artery disease2 interventions
Group B: Triathletes2 interventions
Group C: Strength athletes2 interventions
Group D: young, unathletic group2 interventions
Group E: older, unathletic group2 interventions
Group F: training PAD Patients2 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography

using MSOT

Time frame
through study completion, an average of 1 year
2

Peak oxygen uptake (VO₂peak): VO₂peak (mL·kg-¹·min-¹)

Peak oxygen uptake measured during cardiopulmonary exercise testing (CPET), defined as the highest oxygen uptake achieved during maximal exercise.

Time frame
through study completion, an average of 1 year
3

Respiratory exchange ratio (RER): RER (VCO₂/VO₂, unitless)

Respiratory exchange ratio measured during cardiopulmonary exercise testing (CPET) and calculated as the ratio of carbon dioxide production to oxygen consumption (VCO₂/VO₂).

Time frame
Through study completion, average of 1 year
4

Minute ventilation: Ventilation (L·min-¹)

Minute ventilation measured during cardiopulmonary exercise testing (CPET).

Time frame
Through study completion, average of 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Erlangen

Lead sponsor

PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg

Collaborator

This trial is not recruiting at the moment. You can still explore other options: