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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05655559
Other study ID # Muscle_oxygenation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 30, 2022
Est. completion date May 30, 2023

Study information

Verified date November 2022
Source Saglik Bilimleri Universitesi
Contact Esra PEHLIVAN, Assoc. Prof.
Phone 0216 346 36 36
Email esra.pehlivan@sbu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be conducted on healthy young adults. Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), including muscle oxygenation, will be compared in treadmill and bicycle exercises.


Description:

In recent studies, sensor systems that measure the oxygen level in muscle tissue at the microvascular level have been developed. These devices working with Near Infrared Spectroscopy (NIRS, 630-850 nm) method; It provides measurements of muscle oxygenation level at rest and during exercise. It is known that significant changes in vastus lateralis oxygenation levels measured by the NIRS method are associated with various factors such as exercise intensity, exercise profile and training. The aim of this study is to measure the oxygenation level of the vastus lateralis muscle during the exercises performed on the treadmill and bicycle ergometer, and thus to reveal the effect of using different ergometers on fatigue and sportive performance. Muscle oxygen levels will be measured and evaluated before, during and after exertion. In addition, blood pressure (BP), oxygen saturation (SpO2), dyspnea and fatigue parameters will be recorded and evaluated. If undesirable symptoms are observed during our study, the exercise will be terminated. Within the scope of the project, the acute effect will be examined with the measurements made with the Moxy device on the vastus lateralis muscle during the treadmill and bicycle ergonometer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date May 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Volunteering to participate in the study - No known disease - Be between the ages of 18-25 Exclusion Criteria: - Having cardiopulmonary disease, - Have had lower extremity muscle or joint injuries - Having an orthopedic/neurological disorder - Smoking and alcohol use, - Have suffered a lower extremity muscle or joint injury, - Having an orthopedic/neurological disorder, - Uncontrollable asthma, - PaO2< 50 mmHg, - PaCO2> 70mmHg, - Individuals with a resting systolic blood pressure of 200 mmHg

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnare
Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).
Device:
Moxy Muscle Oxygen Monitor
Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Patient-Reported Dyspnea and Fatigue Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS). Baseline
Primary Measurement of Muscle Oxygenation Measurement of muscle oxygenation with Moxy Monitor. Baseline
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