- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05655559
Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise
Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra PEHLİVAN, Assoc. Prof.
- Phone Number: 2015 0216 346 36 36
- Email: esra.pehlivan@sbu.edu.tr
Study Contact Backup
- Name: Dilara KALAYCI
- Email: dilarakalayyci@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill Group
Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during treadmill exercises.
|
Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).
Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.
|
|
Experimental: Cycle Group
Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during cycling exercises.
|
Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).
Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of Patient-Reported Dyspnea and Fatigue
Time Frame: Baseline
|
Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).
|
Baseline
|
|
Measurement of Muscle Oxygenation
Time Frame: Baseline
|
Measurement of muscle oxygenation with Moxy Monitor.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra PEHLİVAN, Assoc. Prof., Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Muscle_oxygenation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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