Muscle FatigueNCT05528250
The Effect of Quadriceps Muscle Fatigue on Balance
An observational study of Muscle Fatigue, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study; will be conducted to investigate the effect of quadriceps muscle fatigue on static and dynamic balance in regular physical activity individuals and sedentary individuals. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Survey and Treadmill
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2022to 1 Sep 2023
- Phase
- Observational
- 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
- Adult
Study population: Volunteers between the ages of 18-25 who do regular physical activity and are sedentary.
Who may be able to join
- Participant between the ages of 18-25.
- Participant volunteer for research.
- Have not had any lower extremity surgery.
- Not having any lower extremity injury in the last 6 months.
- Not having any chronic lower extremity pain.
Who cannot join
- People with chronic illness.
- Chronic diseases.
- Neurological problems.
- Cardiopulmonary problems.
- Cardiovaskular problems.
- Those who had any lower extremity injury during the study period.
- Being reluctant to continue research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences
Istanbul, Kadıköy
ESRA PEHLİVAN, esra.pehlivan@sbu.edu.tr
About this study
Official title: The Effect of Quadriceps Muscle Fatigue on Static and Dynamic Balance in Regular Physical Activity and Sedentary Individuals
This study; will be conducted to investigate the effect of quadriceps muscle fatigue on static and dynamic balance in regular physical activity individuals and sedentary individuals. International Physical Activity Questionnaire Short Form (IPAQ), Mini BESTest, Modified Borg Scale questionnaire and acute muscle fatigue protocol will be applied and Y balance Test, Flamingo Balance Test, Tecnobody Balance Measurement, EMG measurement, anthropometric measurements and digital dynamometer measurements will be made.
Read the detailed description
Determining the dynamic or static balance of the person will enable us to determine the effect of physical activity levels on the balance in relation to muscle strength and provide us with information about the balance of the person and will give us workable data. Through to these data, we get information about whether the person's level of physical activity is at the desired level. If not, the exercises to be done to reach the desired level or the way the rehabilitation processes to be applied give us important clues in terms of choosing the methods to be applied and determining the direction in which the order will be. If the balance of the person is at the desired level, these data provide us with a great deal of convenience and guide the preservation of this balance.
Knowing the balance data in line with the results to be obtained with this study and using the tests or devices designed in this direction will increase the success of the rehabilitation process and constitute the most important part of the performance increase in physical activity levels.
In case of successful completion of the project, sedentary participants will turn to physical activity to increase their balance. Participants will reduce the risk of falling by increasing their balance by doing physical activity. Therefore, our study will be conducted to investigate the effect of quadriceps muscle fatigue on static and dynamic balance in regular physical activity individuals and sedentary individuals.
Following the approval off the ethics committee, a study will be conducted with 32 regular physical activity individuals and 32 sedentary individuals. The study will start with the approval of the ethics committee and is planned to be completed in May 2022, within 4 months.
Individuals who meet the inclusion criteria and voluntarily accepted to participate in the study will be administered the International Physical Activity Questionnaire Short Form (IPAQ), Mini BESTest, Modified Borg Scale questionnaire and acute muscle fatigue protocol will be applied and Y balance Test, Flamingo Balance Test, Tecnobody Balance Measurement, EMG measurement, anthropometric measurements and digital dynamometer measurements will be made to both regular physical activity individuals and sedentary individuals.
- Conditions
- Muscle Fatigue
- Being tested
- Survey, Treadmill
- Keywords
- Quadriceps Muscle Fatigue, Static Balance, Dinamic Balance, Regular Physical Activity, Sedentary
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
International Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale.
TreadmillDevice
Participants will sign a consent form approved by the ethics committee.Before data collection, height, weight, circumference measurements, leg length, thigh area subcutaneous fat measurement, heart rate, blood pressure and saturation values will be recorded. Before the muscle fatigue protocol, the muscle strength, balance assessment and fatigue of the participants will be evaluated. The muscle fatigue protocol will be done with a treadmill. At the end of the muscle fatigue protocol, the necessary evaluations will be made again and the participants will be rested.
| Study group | Role | What they receive |
|---|---|---|
| İndividuals with do regular physical activity | International Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale will be applied to individuals with do regular physical activity is declared. Receives: Other: Survey; Device: Treadmill | |
| Sedentary individuals with do not have regular physical activity | International Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale will be applied to sedentary individuals with do not have regular physical activity is declared. Receives: Other: Survey; Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial Electromyographic(EMG) Measurement
In the dominant lower extremity to evaluate muscle activity, vastus medialis and vastus lateralis, surface EMG signals will be recorded with the Trigno Avanti Wireless Surface EMG System. While the participant is standing in hip neutral and knee extension, the adhesive EMG electrode will be placed on the reference motor point. Superficial EMG values will be recorded throughout the exercise. During the research, EMG will be recorded from the stimulated muscles by applying two electrodes to the skin for each muscle. The amplitude, duration and shape of the evoked muscle action potentials obtained will be reflected as a result. The amplitudes of the EMG signals will be evaluated. The method to be used when evaluating EMG signal amplitudes will be the raw EMG calculation. While evaluating the data, the computer package programs will benefit.
Measured: Change from baseline emg values in 30 minutes
Static-Dynamic Balance Evaluation with Isokinetic Balance Device
Static and dynamic balance performances will be evaluated using the isokinetic balance measurement system. In this system, there is a sensor in the center of the platform that detects every angular movement and sends the information directly to the computer. For the static balance test, it will be ensured that they stand on both feet with their eyes open. The arms will be positioned next to the body. The measurement will be recorded by asking the participants to maintain their stable position for 30 seconds. For the dynamic balance test, the difficulty level of the test will be set to "30". In the test, they will be asked to circle clockwise 5 times in 60 seconds without bending their knees within the limited area on the computer screen. The Patient Record database module enables the creation of clinical cards for each case. It facilitates the comparison of each case's own tests.
Measured: Change from baseline static and dynamic balance values in 30 minutes
Static Balance
The flamingo balance test will be used to measure the static balance of the participants. Participants will be asked to stand on the 50 cm long, 3 cm wide and 4 cm high apparatus and balance for 1 minute. Every mistake of the participants when their balance is broken will be recorded as points.
Measured: Baseline
Dynamic Balance
Y balance test will be used for the dynamic balance measurement of the participants. Participants will be asked to lie on the Y-shaped mechanism and lie in 3 directions. At least 3 stretches will be made in each direction and the amount of stretching will be recorded in cm.
Measured: Baseline
Secondary outcomes (2)
Evaluation of Leg Fatigue with the Modified Borg Scale (MBS)
This scale was developed by Borg in 1970 to measure the effort expended during physical exercise. It is a scale that is frequently used to evaluate the severity of dyspnea on exertion and the severity of dyspnea at rest. It consists of ten items describing the severity of dyspnea according to their degrees. Defining the severity of dyspnea on the scale makes it easier for patients to apply. In the studies carried out; It is stated that MBS is a reliable scale for determining the severity of dyspnea at rest and exertion, and is associated with respiratory rate and pulmonary function tests. In addition, it is emphasized that MBS is superior to other scales in terms of long-term reproducibility and can be used to predict ventilatory reserves of patients.
Measured: Change from baseline muscle fatigue scale values in 30 minutes
Muscle Strength
Muscle strength measurement will be made with a digital muscle strength device.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start25 Oct 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Özdemir, Saglik Bilimleri Universitesi
- Investigators
- Esra PEHLİVAN, assoc.prof, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528250
- Sponsor's protocol ID
- Balance and The Quadriceps
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quadriceps Muscle Fatigue on Static and Dynamic Balance in Regular Physical Activity and Sedentary Individuals
- ClinicalTrials.gov ID
- NCT05528250
- Acronym / sponsor ID
- Balance and The Quadriceps
- Conditions
- Muscle Fatigue
- Keywords
- Quadriceps Muscle Fatigue, Static Balance, Dinamic Balance, Regular Physical Activity, Sedentary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 6 Sep 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.
This study; will be conducted to investigate the effect of quadriceps muscle fatigue on static and dynamic balance in regular physical activity individuals and sedentary individuals. International Physical Activity Questionnaire Short Form (IPAQ), Mini BESTest, Modified Borg Scale questionnaire and acute muscle fatigue protocol will be applied and Y balance Test, Flamingo Balance Test, Tecnobody Balance Measurement, EMG measurement, anthropometric measurements and digital dynamometer measurements will be made.
Detailed description
Determining the dynamic or static balance of the person will enable us to determine the effect of physical activity levels on the balance in relation to muscle strength and provide us with information about the balance of the person and will give us workable data. Through to these data, we get information about whether the person's level of physical activity is at the desired level. If not, the exercises to be done to reach the desired level or the way the rehabilitation processes to be applied give us important clues in terms of choosing the methods to be applied and determining the direction in which the order will be. If the balance of the person is at the desired level, these data provide us with a great deal of convenience and guide the preservation of this balance.
Knowing the balance data in line with the results to be obtained with this study and using the tests or devices designed in this direction will increase the success of the rehabilitation process and constitute the most important part of the performance increase in physical activity levels.
In case of successful completion of the project, sedentary participants will turn to physical activity to increase their balance. Participants will reduce the risk of falling by increasing their balance by doing physical activity. Therefore, our study will be conducted to investigate the effect of quadriceps muscle fatigue on static and dynamic balance in regular physical activity individuals and sedentary individuals.
Following the approval off the ethics committee, a study will be conducted with 32 regular physical activity individuals and 32 sedentary individuals. The study will start with the approval of the ethics committee and is planned to be completed in May 2022, within 4 months.
Individuals who meet the inclusion criteria and voluntarily accepted to participate in the study will be administered the International Physical Activity Questionnaire Short Form (IPAQ), Mini BESTest, Modified Borg Scale questionnaire and acute muscle fatigue protocol will be applied and Y balance Test, Flamingo Balance Test, Tecnobody Balance Measurement, EMG measurement, anthropometric measurements and digital dynamometer measurements will be made to both regular physical activity individuals and sedentary individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İndividuals with do regular physical activity | – | Other: Survey, Device: TreadmillInternational Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale will be applied to individuals with do regular physical activity is declared. |
| Sedentary individuals with do not have regular physical activity | – | Other: Survey, Device: TreadmillInternational Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale will be applied to sedentary individuals with do not have regular physical activity is declared. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Age groups
- Adult
- Study population
- Volunteers between the ages of 18-25 who do regular physical activity and are sedentary.
Key inclusion criteria (5 listed)
- Participant between the ages of 18-25.
- Participant volunteer for research.
- Have not had any lower extremity surgery.
- Not having any lower extremity injury in the last 6 months.
- Not having any chronic lower extremity pain.
Key exclusion criteria (7 listed)
- People with chronic illness.
- Chronic diseases.
- Neurological problems.
- Cardiopulmonary problems.
- Cardiovaskular problems.
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 |
|---|---|---|
| SurveyInternational Physical Activity Questionnaire (IPAQ)-Short Form ,Anthropometric Measurements and Evaluation Body Weight and Height, Electromyogram (EMG), Digital Dynamometer measurement ,Static Balance Measurements ,Dynamic Balance Measurements ,Tecnobody Balance Measurement , Mini-Balance Evaluation (MiniBESTest) Systems Test ,Y Balance Test ,Flamingo Balance Test ,Modified Borg Scale. | Other | Sedentary individuals with do not have regular physical activity, İndividuals with do regular physical activity |
| TreadmillParticipants will sign a consent form approved by the ethics committee.Before data collection, height, weight, circumference measurements, leg length, thigh area subcutaneous fat measurement, heart rate, blood pressure and saturation values will be recorded. Before the muscle fatigue protocol, the muscle strength, balance assessment and fatigue of the participants will be evaluated. The muscle fatigue protocol will be done with a treadmill. At the end of the muscle fatigue protocol, the necessary evaluations will be made again and the participants will be rested. | Device | Sedentary individuals with do not have regular physical activity, İndividuals with do regular physical activity |
Primary outcome
Superficial Electromyographic(EMG) Measurement
Time frame: Change from baseline emg values in 30 minutes
In the dominant lower extremity to evaluate muscle activity, vastus medialis and vastus lateralis, surface EMG signals will be recorded with the Trigno Avanti Wireless Surface EMG System. While the participant is standing in hip neutral and knee extension, the adhesive EMG electrode will be placed on the reference motor point. Superficial EMG values will be recorded throughout the exercise. During the research, EMG will be recorded from the stimulated muscles by applying two electrodes to the skin for each muscle. The amplitude, duration and shape of the evoked muscle action potentials obtained will be reflected as a result. The amplitudes of the EMG signals will be evaluated. The method to be used when evaluating EMG signal amplitudes will be the raw EMG calculation. While evaluating the data, the computer package programs will benefit.
Static-Dynamic Balance Evaluation with Isokinetic Balance Device
Time frame: Change from baseline static and dynamic balance values in 30 minutes
Static and dynamic balance performances will be evaluated using the isokinetic balance measurement system. In this system, there is a sensor in the center of the platform that detects every angular movement and sends the information directly to the computer. For the static balance test, it will be ensured that they stand on both feet with their eyes open. The arms will be positioned next to the body. The measurement will be recorded by asking the participants to maintain their stable position for 30 seconds. For the dynamic balance test, the difficulty level of the test will be set to "30". In the test, they will be asked to circle clockwise 5 times in 60 seconds without bending their knees within the limited area on the computer screen. The Patient Record database module enables the creation of clinical cards for each case. It facilitates the comparison of each case's own tests.
Static Balance
Time frame: Baseline
The flamingo balance test will be used to measure the static balance of the participants. Participants will be asked to stand on the 50 cm long, 3 cm wide and 4 cm high apparatus and balance for 1 minute. Every mistake of the participants when their balance is broken will be recorded as points.
Dynamic Balance
Time frame: Baseline
Y balance test will be used for the dynamic balance measurement of the participants. Participants will be asked to lie on the Y-shaped mechanism and lie in 3 directions. At least 3 stretches will be made in each direction and the amount of stretching will be recorded in cm.
2 secondary outcomes
Evaluation of Leg Fatigue with the Modified Borg Scale (MBS)
Time frame: Change from baseline muscle fatigue scale values in 30 minutes
Muscle Strength
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
Related trials for Muscle Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
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 PEHLİVAN, assoc.prof study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Fatigue, 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 5 inclusion and 7 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 27 Oct 2022. 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 PEHLİVAN, assoc.prof (02163463636, 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?
Superficial Electromyographic(EMG) Measurement (time frame: Change from baseline emg values in 30 minutes). 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 27 Oct 2022.