- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410638
Intercostal Muscle Oxygenation During Exercise Tests
May 10, 2024 updated by: esra pehlivan, Istanbul Medipol University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
32
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
- Name: Esra Pehlivan
- Phone Number: 02164189616
- Email: fztesrakambur@yahoo.com
Study Contact Backup
- Name: Eylem Cinkılıç
- Email: cinkilic.eylem@gmail.com
Study Locations
-
-
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İstanbul, Turkey, 34668
- Recruiting
- University of Health Sciences Turkey
-
Contact:
- Esra Pehlivan, PhD
- Phone Number: +90 216 418 96 16
- Email: fztesrakambur@yahoo.com
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-
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
Healthy young adults
Description
Inclusion Criteria:
- Being between the ages of 18-35
- Body Mass Index <25 kg/m²
- Participating in the study voluntarily
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
|---|---|
|
Healthy subjects
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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During intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced expiratory pressure in one second
Time Frame: Baseline
|
It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device.
|
Baseline
|
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Evaluation of blood pressure
Time Frame: During the intervention
|
Sistolik and diastolic blood pressure will be measured with the Wrist Blood Pressure Monitor
|
During the intervention
|
|
Evaluation of heart rate
Time Frame: During the intervention
|
It will be measured with a pulse oximeter.
|
During the intervention
|
|
Evaluation of oxygen saturation
Time Frame: During the intervention
|
It will be measured with a pulse oximeter.
|
During the intervention
|
|
Forced vital capacity
Time Frame: Baseline
|
It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 10, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 4, 2024
First Submitted That Met QC Criteria
May 10, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ICM_Moxy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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