NCT05528250

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 27, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 19, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

Quadriceps Muscle FatigueStatic BalanceDinamic BalanceRegular Physical ActivitySedentary

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (2)

  • Evaluation of Leg Fatigue with the Modified Borg Scale (MBS)

    Change from baseline muscle fatigue scale values in 30 minutes

  • Muscle Strength

    Baseline

Study Arms (2)

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.

Other: SurveyDevice: 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.

Other: SurveyDevice: Treadmill

Interventions

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.

Sedentary individuals with do not have regular physical activityİndividuals with do regular physical activity
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.

Sedentary individuals with do not have regular physical activityİndividuals with do regular physical activity

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volunteers between the ages of 18-25 who do regular physical activity and are sedentary.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Kadıköy, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Surveys and QuestionnairesExercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometry

Study Officials

  • Esra PEHLİVAN, assoc.prof

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

Central Study Contacts

Esra PEHLİVAN, assoc.prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phsiotherapy Student

Study Record Dates

First Submitted

August 19, 2022

First Posted

September 6, 2022

Study Start

October 25, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

October 27, 2022

Record last verified: 2022-08

Locations