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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06410638
Other study ID # ICM_Moxy
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2024
Est. completion date June 1, 2025

Study information

Verified date May 2024
Source Istanbul Medipol University Hospital
Contact ESRA PEHLIVAN
Phone 02164189616
Email fztesrakambur@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Six Minute Walking 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 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.

Locations

Country Name City State
Turkey University of Health Sciences Turkey Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During intervention
Secondary Forced expiratory pressure in one second It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device. Baseline
Secondary Evaluation of blood pressure Sistolik and diastolic blood pressure will be measured with the Wrist Blood Pressure Monitor During the intervention
Secondary Evaluation of heart rate It will be measured with a pulse oximeter. During the intervention
Secondary Evaluation of oxygen saturation It will be measured with a pulse oximeter. During the intervention
Secondary Forced vital capacity It will be performed with Cosmed Pony Fx (Italy) desktop spirometry device. Baseline
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