- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06294223
Upper Extremity and Muscle Oxygenation
Investigation of the Correlation Between Upper Extremity Fatigue Level and Muscle Oxygenation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our study aims to determine the acute oxygen response in the upper extremity muscles against a resistance exercise fatigue protocol, in order to demonstrate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue in upper extremity use, and to provide reference information for the development of exercise programs.
It is known that resistance exercise increases resting energy expenditure and promotes fat oxidation for weight loss. Changes in cardiopulmonary function that occur in chronic diseases reduce oxygen uptake and decrease energy production, leading to increased fatigue. Resistance exercises in chronic diseases can regulate an individual's energy production capacity.
The main objective of our study is to investigate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue by determining the oxygen response in the upper extremity muscles based on a resistance exercise protocol.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Pehlivan, Ass. Prof
- Phone Number: 05058527913
- Email: esra.pehlivan@sbu.edu.tr
Study Contact Backup
- Name: Tuna Sümer, PT
- Phone Number: 05534422490
- Email: tnasmrgs@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34010
- Recruiting
- Saglik Bilimleri University
-
Contact:
- Esra Pehlivan, Ass Prof
- Phone Number: 05058527913
- Email: esra.pehlivan@sbu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Being over 18 years old
- Having a Body Mass Index (BMI) value between 23-30 kg/m2
- Absence of comorbid disease of the orthopedic, neurological, cardiopulmonery system
Exclusion Criteria:
- Smoking / alcohol use
- Presence of orthopedic disease effecting the upper extremity or previous surgery
- Presence of cardiopulmonery disease that prevents exercise
- Participants who performed resistance exercise regulary for more than 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Measurement of Upper Extremity Muscle Oxygenation
Measuring muscle oxygenation with fatigue protocol.
|
Exercises will be followed by near-infrared spectroscopy.
Fatigue protocol will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of Blood Pressure
Time Frame: Measurement will be made before and immediately after exercise.
|
Systolic/diastolic blood pressure will be determined with a digital blood pressure monitor and will be recorded in mmHg.
Measurements will be taken via the right brachial artery in a comfortable position.
|
Measurement will be made before and immediately after exercise.
|
|
Saturation Measurement
Time Frame: Measurement will be made before and immediately after exercise.
|
Oxygen saturation will be measured with a pulse oximeter device and recorded on the form.
|
Measurement will be made before and immediately after exercise.
|
|
Muscle Oxygenation Measurement
Time Frame: Baseline.
|
MOXY Pro (Moxy 3, Firmware 1.1 Hutchinson MN, USA), a near-infrared spectroscopy device, will be used to measure the muscle oxygen rate (SmO2) and total hemoglobin amount (tHb) of the biceps brachii muscle.
|
Baseline.
|
|
Determination of Heart Rate
Time Frame: Measurement will be made before and immediately after exercise.
|
Heart rate will be determined with a digital blood pressure monitor and will be recorded in BPM.
|
Measurement will be made before and immediately after exercise.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Pehlivan, Ass. Prof., Saglik Bilimleri Universitesi
- Principal Investigator: Mehmet Burak Uyaroğlu, Pt.PhD(c), Saglik Bilimleri Universitesi
- Study Chair: Tuna Sümer, PT, Saglik Bilimleri Universitesi
- Study Chair: Melisa Eren, PT, Saglik Bilimleri Universitesi
- Study Chair: Ceren Balıkcı, PT, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- SaglikBilU
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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