Investigation of the Effects of Chronotype Differences on Balance and Muscle Strength in Young Adults (Chronotype)

May 26, 2025 updated by: merve yilmaz menek, Istanbul Medipol University Hospital
The aim of this study is to investigate the effects of chronotype differences on balance and muscle strength in young adults. Chronotypes of all participants will be determined using the Morningness-Eveningness Questionnaire. All assessment measurements determined for young adult individuals will be performed first at 09:00 in the morning and then again at 19:00 in the evening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to investigate the effects of chronotype differences on balance and muscle strength in young adults. Inclusion criteria are being between 45-65 years old, not having any neurological or orthopedic disorders, not having a vestibular disease that causes balance problems. Exclusion criteria are trauma history, anatomical deformities and skeletal system fractures, having a previous injury, and the presence of pain that will prevent participation in the tests. Chronotypes of all participants will be determined using the Morningness-Eveningness Questionnaire. All assessment measurements determined for young adult individuals will be performed first at 09:00 in the morning and then again at 19:00 in the evening. Muscle strength and balance assessments made in the morning and evening will be compared. Chronotypes of the participants will be evaluated with the Morningness-Eveningness Questionnaire, their balance will be evaluated with the One-Legged Standing Test, lower extremity muscle strength with a myometer, and their functionality will be evaluated with the Timed Stand-Up-Sit Test and the 30-Second Sit-Up Test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being between 45-65,
  • not having any neurological or orthopedic disorder,
  • not having a vestibular disease that causes balance problems.

Exclusion Criteria:

  • trauma history,
  • anatomical deformities and skeletal system fractures,
  • having a previous injury and the presence of pain that would prevent participation in the tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Morning chronotype group
All assessment measurements determined for individuals with morning chronotype will be performed first at 09:00 in the morning and then again at 19:00 in the evening.
Other: Morning chronotype
All assessment measurements determined for individuals with morning chronotype will be performed first at 09:00 in the morning and then again at 19:00 in the evening. Muscle strength balance assessments performed in the morning and evening will be compared.
Experimental: Evening chronotype group
All assessment measurements determined for individuals with evening chronotype will be performed first at 09:00 in the morning and then again at 19:00 in the evening.
Other: Evening chronotype
All assessment measurements determined for individuals with evening chronotype will be performed first at 09:00 in the morning and then again at 19:00 in the evening. Muscle strength balance assessments performed in the morning and evening will be compared.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morningness-Eveningness Questionnaire
Time Frame: 20 minutes
A questionnaire form that determines morningness and eveningness types will be used to subjectively evaluate circadian rhythm. defi - nitely morning type (70-86), moderately morning type (59-69), neither type (42-58), moderately evening type (31-41), and defi nitely evening type (16-30).
20 minutes
Single-leg standing test
Time Frame: 20 minutes
This test measures a person's standing ability and balance.
20 minutes
Muscle strength test
Time Frame: 20 minutes
Myometry will be used to objectively measure the strength of the quadriceps and hamstring muscles. Myometry is an evaluation method that objectively evaluates muscle strength and provides more sensitive results than manual muscle testing.
20 minutes
Timed up and go testTest:
Time Frame: 20 minutes
A simple screening test that provides a sensitive and specific measure of fall risk and balance in older adults.
20 minutes
30 Second Sit-to-Stand Test
Time Frame: 20 minutes
A test that evaluates the participant's sit-to-stand activity, lower extremity muscle strength and balance status.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MERVE YILMAZ MENEK, Assoc. Prof., Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-772.02-7691
  • Istanbul Medipol University (Other Identifier: Istanbul Medipol University Ethics Committee Decision No: 855/2021)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We can share IPD when it isi necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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