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Upper Extremity and Muscle Oxygenation

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ClinicalTrials.gov Identifier: NCT06294223
Recruitment Status : Recruiting
First Posted : March 5, 2024
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Tuna Sümer, Saglik Bilimleri Universitesi

Study Description
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Brief Summary:
The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy.

Condition or disease Intervention/treatment Phase
Near-infrared Spectroscopy Muscle Oxygenation Device: Exercise follow up with near-infrared spectroscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Correlation Between Upper Extremity Fatigue Level and Muscle Oxygenation
Actual Study Start Date : March 1, 2024
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Measurement of Upper Extremity Muscle Oxygenation
Measuring muscle oxygenation with fatigue protocol.
 Device: Exercise follow up with near-infrared spectroscopy
Exercises will be followed by near-infrared spectroscopy. Fatigue protocol will be applied.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06294223


Contacts
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Contact: Esra Pehlivan, Ass. Prof 05058527913 esra.pehlivan@sbu.edu.tr
Contact: Tuna Sümer, PT 05534422490 tnasmrgs@gmail.com

Locations
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Turkey
Saglik Bilimleri University Recruiting
Istanbul, Turkey, 34010
Contact: Esra Pehlivan, Ass Prof    05058527913    esra.pehlivan@sbu.edu.tr   
Sponsors and Collaborators
Saglik Bilimleri Universitesi
Investigators
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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
More Information
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Responsible Party: Tuna Sümer, PT, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT06294223    
Other Study ID Numbers: SaglikBilU
First Posted: March 5, 2024    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuna Sümer, Saglik Bilimleri Universitesi:
Near-infrared Spectroscopy
Resistance Exercise
Exercise Intensity
Muscle Oxygenation
Muscle Activation