- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896838
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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 Locations
-
-
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
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 |
|---|
|
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
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
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
Investigators
- 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)
June 4, 2025
Primary Completion (Actual)
December 2, 2025
Study Completion (Actual)
April 6, 2026
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 25, 2025
First Posted (Actual)
March 26, 2025
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Near-Infrared Spectroscopy
-
Nonin Medical, IncCompletedNear Infrared SpectroscopyUnited States
-
Rigshospitalet, DenmarkCompletedNear Infrared SpectroscopyDenmark
-
Antalya Training and Research HospitalCompleted
-
Medical University of GrazCompletedNear-Infrared Spectroscopy | Umbilical Cord IssueAustria
-
China International Neuroscience InstitutionCompletedNear-Infrared Spectroscopy in Endovascular Neurosurgery
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingNerve Block | Near Infrared Spectroscopy | Lumbar Plexus
-
Ting LiUnknownNear Infrared Spectroscopy | Low Level Light/Laser TherapyChina
-
Rigshospitalet, DenmarkThe Augustinus Foundation, Denmark.CompletedNear Infrared SpectroscopyDenmark
-
Saglik Bilimleri UniversitesiRecruiting
-
Rigshospitalet, DenmarkThe Augustinus Foundation, Denmark.CompletedNear-infrared Spectroscopy, Transition, Caesarean SectionDenmark