Muscle OxygenationNCT06410638
Intercostal Muscle Oxygenation During Exercise Tests
An observational study of Muscle Oxygenation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to determine the effects of different exercise capacity tests on intercostal muscle oxygenation and to reveal the effect of changing accessory respiratory muscle oxygenation on exercise test success. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Oxygenation
- What is being tested?
- Six Minute Walking Test and Shuttle walking test
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 1 Jun 2025
- 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: Healthy young adults
Who may be able to join
- Being between the ages of 18-35
- Body Mass Index \<25 kg/m²
- Participating in the study voluntarily
Who cannot join
- Being a smoker
- Presence of any systemic, orthopedic or cardiopulmonary disease that may prevent exercise tests
- Presence of any diagnosed respiratory, vascular and heart disease
Trial locations and contacts
1 site in 1 country.
Eylem Cinkılıç contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Turkey
Istanbul, 34668
Esra Pehlivan, PhD, +90 216 418 96 16, fztesrakambur@yahoo.com
About this study
Official title: Effect of Different Exercise Capacity Tests on Intercostal Muscle Oxygenation
The aim of our study is to determine the effects of different exercise capacity tests on intercostal muscle oxygenation and to reveal the effect of changing accessory respiratory muscle oxygenation on exercise test success.
Read the detailed description
In the study, intercostal muscle oxygenation will be measured in different exercise capacity tests. A total of 32 healthy young women and men between the ages of 18-25 who meet the inclusion criteria and voluntarily agree to participate in the study will be included in the study. The cases will be randomized into 2 groups: Six minute walking test group and incremental shuttle walking test group. Heart rate, oxygen saturation, and fatigue levels will be measured with the modified Borg scale before and after the tests. During the tests, oxygen levels of the intercostal muscles will be monitored with the MOXY device. After sufficient wash out time, the groups will be crossed and different exercise tests will be applied to the cases. The result of our study will provide information about the use of intercostal muscles during different exercise tests. As a result of the study, results that can be interpreted for patient groups with circulatory system, respiratory system and physical limitations will be obtained.
- Conditions
- Muscle Oxygenation
- Being tested
- Six Minute Walking Test, Shuttle walking test
- Keywords
- exercise capacity test, muscle oxygenation, intercostal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six Minute Walking TestDiagnostic test
It is applied in a 30 m long corridor in an indoor environment, and the distance walked by the patient in a six-minute period, oxygen saturation, heart rate, and change in dyspnea are recorded. For this, before starting the test, oxygen saturation, heart rate, arterial blood pressure and dyspnea level according to the Borg scale are recorded. The same parameters are measured again at the end of the test. The feature of this test is that the person walks at his own pace, stopping when necessary and allowing the use of oxygen. It is an exercise test that is easy to perform and well tolerated.
Shuttle walking testDiagnostic test
Shuttle walking test at increasing speed is an exercise test in which walk between two cones 10 m apart at an increasing speed throughout the test and each 10-meter journey between the two cones is counted as a shuttle.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Diagnostic Test: Six Minute Walking Test; Diagnostic Test: Shuttle walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Oxygenation of intercostal muscles
The measurement will be made with the MOXY device. The device will be placed on the intercostal muscle and measurements will be taken during the exercise tests. Measured values at the beginning, end and every 1 minute will be taken and analyzed.
Measured: During intervention
Secondary outcomes (5)
Forced expiratory pressure in one second
It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device.
Measured: Baseline
Evaluation of blood pressure
Sistolik and diastolic blood pressure will be measured with the Wrist Blood Pressure Monitor
Measured: During the intervention
Evaluation of heart rate
It will be measured with a pulse oximeter.
Measured: During the intervention
Evaluation of oxygen saturation
It will be measured with a pulse oximeter.
Measured: During the intervention
Forced vital capacity
It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 May 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle OxygenationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410638
- Sponsor's protocol ID
- ICM_Moxy
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Exercise Capacity Tests on Intercostal Muscle Oxygenation
- ClinicalTrials.gov ID
- NCT06410638
- Acronym / sponsor ID
- ICM_Moxy
- Conditions
- Muscle Oxygenation
- Keywords
- exercise capacity test, muscle oxygenation, intercostal muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 May 2024 (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 aim of our study is to determine the effects of different exercise capacity tests on intercostal muscle oxygenation and to reveal the effect of changing accessory respiratory muscle oxygenation on exercise test success.
Detailed description
In the study, intercostal muscle oxygenation will be measured in different exercise capacity tests. A total of 32 healthy young women and men between the ages of 18-25 who meet the inclusion criteria and voluntarily agree to participate in the study will be included in the study. The cases will be randomized into 2 groups: Six minute walking test group and incremental shuttle walking test group. Heart rate, oxygen saturation, and fatigue levels will be measured with the modified Borg scale before and after the tests. During the tests, oxygen levels of the intercostal muscles will be monitored with the MOXY device. After sufficient wash out time, the groups will be crossed and different exercise tests will be applied to the cases. The result of our study will provide information about the use of intercostal muscles during different exercise tests. As a result of the study, results that can be interpreted for patient groups with circulatory system, respiratory system and physical limitations will be obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Diagnostic Test: Six Minute Walking Test, Diagnostic Test: Shuttle walking test |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults
Key inclusion criteria (3 listed)
- Being between the ages of 18-35
- Body Mass Index \<25 kg/m²
- Participating in the study voluntarily
Key exclusion criteria (3 listed)
- Being a smoker
- Presence of any systemic, orthopedic or cardiopulmonary disease that may prevent exercise tests
- Presence of any diagnosed respiratory, vascular and heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six Minute Walking TestIt is applied in a 30 m long corridor in an indoor environment, and the distance walked by the patient in a six-minute period, oxygen saturation, heart rate, and change in dyspnea are recorded. For this, before starting the test, oxygen saturation, heart rate, arterial blood pressure and dyspnea level according to the Borg scale are recorded. The same parameters are measured again at the end of the test. The feature of this test is that the person walks at his own pace, stopping when necessary and allowing the use of oxygen. It is an exercise test that is easy to perform and well tolerated. | Diagnostic test | Healthy subjects |
| Shuttle walking testShuttle walking test at increasing speed is an exercise test in which walk between two cones 10 m apart at an increasing speed throughout the test and each 10-meter journey between the two cones is counted as a shuttle. | Diagnostic test | Healthy subjects |
Primary outcome
Evaluation of Muscle Oxygenation of intercostal muscles
Time frame: During intervention
The measurement will be made with the MOXY device. The device will be placed on the intercostal muscle and measurements will be taken during the exercise tests. Measured values at the beginning, end and every 1 minute will be taken and analyzed.
5 secondary outcomes
Forced expiratory pressure in one second
Time frame: Baseline
Evaluation of blood pressure
Time frame: During the intervention
Evaluation of heart rate
Time frame: During the intervention
Evaluation of oxygen saturation
Time frame: During the intervention
Forced vital capacity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Eylem Cinkılıç contact
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 Muscle Oxygenation, run by Istanbul Medipol University Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ESRA PEHLİVAN (02164189616, fztesrakambur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Muscle Oxygenation of intercostal muscles (time frame: During intervention). 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 14 May 2024.