Muscle OxygenationNCT05655559
Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise
A study testing Questionnare and Moxy Muscle Oxygen Monitor in people with Muscle Oxygenation and Treadmill, run by Saglik Bilimleri Universitesi.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Oxygenation, Treadmill
- What is being tested?
- Questionnare and Moxy Muscle Oxygen Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 May 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- No known disease
- Be between the ages of 18-25
Who cannot join
- 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,
Show all 10Show fewer
- Uncontrollable asthma,
- PaO2< 50 mmHg,
- PaCO2> 70mmHg,
- Individuals with a resting systolic blood pressure of 200 mmHg
Trial locations and contacts
No sites are listed yet.
Dilara KALAYCI contact
About this study
Official title: Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises
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.
Read the 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.
- Conditions
- Muscle Oxygenation, Treadmill
- Being tested
- Questionnare, Moxy Muscle Oxygen Monitor
- Keywords
- muscle oxygenation, treadmill, cycle, moxy, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnareOther
Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).
Moxy Muscle Oxygen MonitorDevice
Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Group | Experimental | Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during treadmill exercises. Receives: Other: Questionnare; Device: Moxy Muscle Oxygen Monitor |
| Cycle Group | Experimental | Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during cycling exercises. Receives: Other: Questionnare; Device: Moxy Muscle Oxygen Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Patient-Reported Dyspnea and Fatigue
Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).
Measured: Baseline
Measurement of Muscle Oxygenation
Measurement of muscle oxygenation with Moxy Monitor.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start30 Dec 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle OxygenationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra PEHLİVAN, Assoc. Prof., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655559
- Sponsor's protocol ID
- Muscle_oxygenation
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2022
- Last updated
- 19 Dec 2022
- 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 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises
- ClinicalTrials.gov ID
- NCT05655559
- Acronym / sponsor ID
- Muscle_oxygenation
- Conditions
- Muscle Oxygenation, Treadmill
- Keywords
- muscle oxygenation, treadmill, cycle, moxy, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 19 Dec 2022 (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 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Group | Experimental | Other: Questionnare, Device: Moxy Muscle Oxygen MonitorHemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during treadmill exercises. |
| Cycle Group | Experimental | Other: Questionnare, Device: Moxy Muscle Oxygen MonitorHemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during cycling exercises. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- No known disease
- Be between the ages of 18-25
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| QuestionnareMeasurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS). | Other | Cycle Group, Treadmill Group |
| Moxy Muscle Oxygen MonitorMeasurement of muscle oxygenation with Moxy Muscle Oxygen Monitor. | Device | Cycle Group, Treadmill Group |
Primary outcome
Measurement of Patient-Reported Dyspnea and Fatigue
Time frame: Baseline
Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).
Measurement of Muscle Oxygenation
Time frame: Baseline
Measurement of muscle oxygenation with Moxy Monitor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- 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.
Dilara KALAYCI contact
Esra PEHLİVAN, Assoc. Prof. study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing Questionnare and Moxy Muscle Oxygen Monitor in people with Muscle Oxygenation and Treadmill, run by Saglik Bilimleri Universitesi.
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 3 inclusion and 10 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 PEHLİVAN, Assoc. Prof. (0216 346 36 36 ext. 2015, 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?
Measurement of Patient-Reported Dyspnea and Fatigue (time frame: Baseline). The study lists 2 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 19 Dec 2022.