Comparison of Intercostal and Quadriceps Femoris Muscle Oxygenation in Women and Men

April 7, 2026 updated by: Başak KAVALCI KOL, Kirsehir Ahi Evran Universitesi

Comparison of Intercostal and Quadriceps Femoris Muscle Oxygenation During Upper Extremity and Lower Extremity Maximal Exercise Tests in Women and Men

The differences in physiological responses due to gender during exercise tests have recently begun to be investigated. The oxygen use of respiratory muscles and lower extremity muscles may differ during upper and lower extremity exercise tests, but there is no study on this subject in the literature. The primary aim of this study was to compare intercostal and quadriceps femoris muscle oxygenation during upper extremity and lower extremity maximal exercise tests in women and men. The secondary aim of the study was to investigate the relationship between intercostal and quadriceps femoris muscle oxygenation and upper extremity and lower extremity exercise capacity, body composition, respiratory muscle strength, and respiratory muscle endurance in women and men.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Differences in physiological responses due to gender during exercise tests have recently been investigated. In a study, it was determined that respiratory muscles such as intercostals use more oxygen during exercise tests in women. It was shown that this situation is related to the smaller rib cage, mechanical disadvantage of the diaphragm, narrower airway diameter and greater activation of accessory respiratory muscles in women. The fact that respiratory muscles consume more oxygen in women causes blood flow to the respiratory muscles to be higher. This situation causes a decrease in the amount of oxygen carried to the peripheral muscles, which may cause early fatigue in the peripheral muscles during the exercise test. Muscle oxygen saturation (SmO2) indicates the oxygen uptake and oxygen consumption of the muscle. This can be determined using continuous wave near infrared spectroscopy (NIRS, 630-850 nm) device, which measures changes in the amount of hemoglobin bound to oxygen at the microvascular level. Research on gender-related differences and how SmO2 levels in these muscles change during exercise in women is limited. The aim of the study was to compare intercostal and quadriceps femoris muscle oxygenation during upper extremity and lower extremity maximal exercise tests in women and men.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Kırşehir, Merkez, Turkey (Türkiye), 40100
        • Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Active individuals who are healthy, with no history of respiratory, cardiovascular, metabolic, musculoskeletal, or acute infections for at least 2 weeks prior to testing will be enrolled in the study.

Description

Inclusion Criteria:

  • Aged between 18-35 years,
  • Physically active (doing moderate intensity physical activity 3 days a week for 150 minutes / week)
  • Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

  • Healthy individuals with any diagnosed chronic or systemic disease,
  • Those who smoke 10 packs x years or more,
  • Those with pneumonia or any acute infection,
  • Those with any psychiatric disorder will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Female Group
Healthy, active individuals with no history of respiratory, cardiovascular, metabolic, musculoskeletal or acute infection at least 2 weeks before the test will be included in the study. Individuals whose activity level is in category 3 according to the International Physical Activity Questionnaire results (at least 3 days of vigorous activity providing a minimum of 1500 metabolic equivalent (MET)-minutes (min)/week or more days of walking, moderate or vigorous activity providing a minimum of 3000 MET-min/week, 7 or more days) will be included.
Male Group
Healthy, active individuals with no history of respiratory, cardiovascular, metabolic, musculoskeletal or acute infection at least 2 weeks before the test will be included in the study. Individuals whose activity level is in category 3 according to the International Physical Activity Questionnaire results (at least 3 days of vigorous activity providing a minimum of 1500 MET-min/week or more days of walking, moderate or vigorous activity providing a minimum of 3000 MET-min/week, 7 or more days) will be included.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal symptom limited cycle ergometer test
Time Frame: First day
In order to evaluate the exercise capacity of individuals, a symptom-limited increasing workload exercise test will be applied on a bicycle ergometer. In the test, patients will warm up at 0 watts for 3 minutes and then proceed to the loading period of the test. During the loading period, patients will be provided with a 20-watt workload increase every 2 minutes to reach their maximal workload. Patients will be encouraged to continue testing to the maximum level they can sustain during the test. The test will be terminated by the practitioner when patients reach their maximal heart rate or if they wish to terminate the test due to symptoms.
First day
Maximal symptom limited arm ergometer test
Time Frame: Second day
Arm ergometer test will be used to evaluate the upper extremity exercise capacity of individuals. The test will be performed in a sitting position with the ergometer height at shoulder level. The arm ergometer test will begin at 0 watts (W) workload and 45-55 rpm at each stage. The workload will be increased by 10 W every two minutes. The highest workload reached during the test will be recorded as watt.
Second day
Evaluation of Quadriceps Femoris Muscle Oxygenation
Time Frame: First day
Muscle oxygen level and total hemoglobin level of quadriceps femoris will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before cycle ergometer test, during testing and during post-test recovery.
First day
Evaluation of Intercostals Muscle Oxygenation
Time Frame: Second day
Muscle oxygen level and total hemoglobin level of and intercostal muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before arm ergometer test, during testing and during post-test recovery.
Second day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of respiratory muscle strength
Time Frame: Second day
n the evaluation of respiratory muscle strength, an electronic mouth pressure device will be used, which complies with American Thoracic Society and European Respiratory Society criteria. Maximal inspiratory pressure and maximal expiratory pressures of the individuals will be measured with the mouth pressure measuring device.
Second day
Evaluation of respiratory muscle endurance
Time Frame: Second day
The incremental threshold workload test will be used to evaluate respiratory muscle endurance. The PowerBreathe Wellness® (HaB International Ltd. Southam, UK) inspiratory muscle trainer will be used in the incremental threshold load test. The measurement will start with 30% of the maximal inspiratory pressure. Every two minutes, pressures will be increased by 10%. At the end of the test, the highest pressure value that the participants can maintain for one minute will be recorded in centimetre of water pressure and the total time will be recorded in seconds, and the respiratory muscle endurance result value will be calculated by multiplying these two result values
Second day
Evaluation of body composition
Time Frame: First day
Total body weight, body fat percentage and body fat percentage of individuals will be evaluated by bioelectrical impedance analysis system. Bioelectrical impedance analyzer is a high-speed, low-cost and non-invasive device. The device provides low-dose and different-frequency electrical current to the body. Impedance analysis expresses the resistance of body tissues to this low-dose electrical transmission and is inversely proportional to conductivity. While bone and fat tissue encounter stronger resistance during different electrical current advances, muscle tissue and visceral organs encounter lower resistance during transmission. In this way, it provides information about body fat, bone and muscle ratios. The device will thus present data such as body fat percentage and body fat ratio as output in a single report with the different electrical currents it sends. Bioelectrical impedance analysis measurements have a good level of reliability (ICC≥0.82).
First day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirsehir Ahi Evran Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Başak KAVALCI KOL, PhD, Kirsehir Ahi Evran Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AhiEvranU528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the study, all data will be stored in a locked cabinet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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