Near-Infrared SpectroscopyNCT06896838
Comparison of Intercostal and Quadriceps Femoris Muscle Oxygenation in Women and Men
An observational study of Near-Infrared Spectroscopy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Near-Infrared Spectroscopy
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2025to 6 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit
Kırşehir, Merkez, 40100
About this study
Official title: 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.
Read the 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.
- Conditions
- Near-Infrared Spectroscopy
- Keywords
- muscle oxygenation, exercise capacity, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Maximal symptom limited cycle ergometer test
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.
Measured: First day
Maximal symptom limited arm ergometer test
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.
Measured: Second day
Evaluation of Quadriceps Femoris Muscle Oxygenation
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.
Measured: First day
Evaluation of Intercostals Muscle Oxygenation
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.
Measured: Second day
Secondary outcomes (3)
Evaluation of respiratory muscle strength
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.
Measured: Second day
Evaluation of respiratory muscle endurance
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
Measured: Second day
Evaluation of body composition
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).
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start4 Jun 2025
- Primary completion2 Dec 2025
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near-Infrared SpectroscopyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak KAVALCI KOL, Kirsehir Ahi Evran Universitesi
- Investigators
- Başak KAVALCI KOL, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896838
- Sponsor's protocol ID
- AhiEvranU528
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the study, all data will be stored in a locked cabinet.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intercostal and Quadriceps Femoris Muscle Oxygenation During Upper Extremity and Lower Extremity Maximal Exercise Tests in Women and Men
- ClinicalTrials.gov ID
- NCT06896838
- Acronym / sponsor ID
- AhiEvranU528
- Conditions
- Near-Infrared Spectroscopy
- Keywords
- muscle oxygenation, exercise capacity, body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Evaluation of respiratory muscle strength
Time frame: Second day
Evaluation of respiratory muscle endurance
Time frame: Second day
Evaluation of body composition
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. In the study, all data will be stored in a locked cabinet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Başak KAVALCI KOL, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Near-Infrared Spectroscopy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal symptom limited cycle ergometer test (time frame: First day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.