Near-infrared SpectroscopyNCT06294223
Upper Extremity and Muscle Oxygenation
A study testing Exercise follow up with near-infrared spectroscopy in people with Near-infrared Spectroscopy and Muscle Oxygenation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Near-infrared Spectroscopy, Muscle Oxygenation
- What is being tested?
- Exercise follow up with near-infrared spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri University
Istanbul, 34010
Esra Pehlivan, Ass Prof, 05058527913, esra.pehlivan@sbu.edu.tr
About this study
Official title: Investigation of the Correlation Between Upper Extremity Fatigue Level and Muscle Oxygenation
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.
Read the 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.
- Conditions
- Near-infrared Spectroscopy, Muscle Oxygenation
- Being tested
- Exercise follow up with near-infrared spectroscopy
- Keywords
- Near-infrared Spectroscopy, Resistance Exercise, Exercise Intensity, Muscle Oxygenation, Muscle Activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise follow up with near-infrared spectroscopyDevice
Exercises will be followed by near-infrared spectroscopy. Fatigue protocol will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of Upper Extremity Muscle Oxygenation | Experimental | Measuring muscle oxygenation with fatigue protocol. Receives: Device: Exercise follow up with near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Blood Pressure
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.
Measured: Measurement will be made before and immediately after exercise.
Saturation Measurement
Oxygen saturation will be measured with a pulse oximeter device and recorded on the form.
Measured: Measurement will be made before and immediately after exercise.
Muscle Oxygenation Measurement
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.
Measured: Baseline.
Determination of Heart Rate
Heart rate will be determined with a digital blood pressure monitor and will be recorded in BPM.
Measured: Measurement will be made before and immediately after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near-infrared SpectroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuna Sümer, Saglik Bilimleri Universitesi
- Investigators
- Esra Pehlivan, Ass. Prof., Study director, Saglik Bilimleri UniversitesiMehmet Burak Uyaroğlu, Pt.PhD(c), Principal investigator, Saglik Bilimleri UniversitesiTuna Sümer, PT, Study chair, Saglik Bilimleri UniversitesiMelisa Eren, PT, Study chair, Saglik Bilimleri UniversitesiCeren Balıkcı, PT, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294223
- Sponsor's protocol ID
- SaglikBilU
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation Between Upper Extremity Fatigue Level and Muscle Oxygenation
- ClinicalTrials.gov ID
- NCT06294223
- Acronym / sponsor ID
- SaglikBilU
- Conditions
- Near-infrared Spectroscopy, Muscle Oxygenation
- Keywords
- Near-infrared Spectroscopy, Resistance Exercise, Exercise Intensity, Muscle Oxygenation, Muscle Activation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of Upper Extremity Muscle Oxygenation | Experimental | Device: Exercise follow up with near-infrared spectroscopyMeasuring muscle oxygenation with fatigue protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise follow up with near-infrared spectroscopyExercises will be followed by near-infrared spectroscopy. Fatigue protocol will be applied. | Device | Measurement of Upper Extremity Muscle Oxygenation |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Pehlivan, Ass. Prof. study director
Saglik Bilimleri Universitesi
Mehmet Burak Uyaroğlu, Pt.PhD(c) principal investigator
Saglik Bilimleri Universitesi
Tuna Sümer, PT study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise follow up with near-infrared spectroscopy in people with Near-infrared Spectroscopy and Muscle Oxygenation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Pehlivan, Ass. Prof (05058527913, esra.pehlivan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Blood Pressure (time frame: Measurement will be made before and immediately after exercise.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.