Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05655559

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Oxygenation Treadmill	Other: Questionnare Device: Moxy Muscle Oxygen Monitor	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises

Anticipated Study Start Date :

Dec 30, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

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.	Other: Questionnare Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS). Device: Moxy Muscle Oxygen Monitor 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.	Other: Questionnare Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS). Device: Moxy Muscle Oxygen Monitor Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.

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.

Other: Questionnare

Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).

Device: Moxy Muscle Oxygen Monitor

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.

Other: Questionnare

Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).

Device: Moxy Muscle Oxygen Monitor

Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.

Outcome Measures

Primary Outcome Measures

Measurement of Patient-Reported Dyspnea and Fatigue [Baseline]
Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).
Measurement of Muscle Oxygenation [Baseline]
Measurement of muscle oxygenation with Moxy Monitor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saglik Bilimleri Universitesi

Investigators

Study Director: Esra PEHLİVAN, Assoc. Prof., Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saglik Bilimleri Universitesi

ClinicalTrials.gov Identifier:

NCT05655559

Other Study ID Numbers:

Muscle_oxygenation

First Posted:

Dec 19, 2022

Last Update Posted:

Dec 19, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Saglik Bilimleri Universitesi

Study Results

No Results Posted as of Dec 19, 2022