The Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture on Sedentary Individuals

February 26, 2024 updated by: Beyza Nur Yumak, Medipol University

Investigation of the Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture in Healthy Sedentary Individuals

There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary individuals. According to the results of International Physical Activity Questionnaire, the researcher includes sedentary individuals over the age of 18 in the study. The participants are divided into two groups as control (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle endurance tests. Intervention includes core stabilization exercises 3 times a week and walking twice a week for 6 weeks. There is no treatment or intervention for the control group. The researcher evaluates both groups at the beginning and 6 weeks after the intervention.

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

Core stabilization exercises are performed under the supervision of a physiotherapist as face-to-face exercises, guided online exercises, and as an individual home exercise each once a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8 seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises will be achieved by increasing the difficulty level of the exercises according to the condition of the participant once every two weeks.

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 (Actual)

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34126
        • Beyza Nur Yumak

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be voluntary to participate in the study
  • Being between the ages of 18-40
  • Being sedentary

Exclusion Criteria:

  • Not volunteering to participate in the study
  • Having a complaint of low back pain in the last two months
  • Being pregnant
  • Having chronic lower extremity pain
  • Having an orthopedic disease and undergoing a surgical operation
  • Having had abdominal surgery
  • Being a neurological disease pathology

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: Exercise Group
Intervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days.
Other: Core Stabilization Exercises
Core stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.Each exercise was performed for 7-8 seconds with 10 repetitions. Progression in the exercises was achieved by increasing the difficulty level of the exercises according to the participant's condition once every two weeks.
No Intervention: Control Group
There is no exercise or intervention for control group.

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
New York Posture Assessment Scale
Time Frame: 6 weeks
This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes. There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment. In the evaluation, five (5) points are given if the person's posture is correct, three (3) points if moderately impaired, and one (1) point if severely impaired. At the end of the evaluation, the total maximum score is 65 and the minimum is 13. Postural disturbances increase as the score decreases.
6 weeks
KoreBalance Balance System
Time Frame: 6 weeks
The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. As stated in the device manual, a score of 700 and below was considered normal and above was considered risky for static balance and a score of 2000 and below was considered normal and above was considered risky for dynamic tests. A higher score is associated with more balance disorders.
6 weeks
Trunk Muscle Endurance Tests
Time Frame: 6 weeks
The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated by recording the maximum time that the person can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says cannot continue the test.
6 weeks
International Physical Activity Questionnaire
Time Frame: Before Intervention (First Assesment)
This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.
Before Intervention (First Assesment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Stabilizer Pressure Biofeedback Unite
Time Frame: 6 weeks
This device evaluates contraction of deep abdominal muscles, muscle activity and segmental stability. The device has values between 0 mmHg and 200 mmHg, varying in intervals of 2 mmHg. Movement or change in position causes volume changes in the pressure bag.
6 weeks

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.
Medipol University

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.
  • Study Director: Ayşe Nur Tunali, Professor, 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

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 27, 2023

Primary Completion (Actual)

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.
November 30, 2023

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.
May 1, 2024

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).
July 24, 2023

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.
July 24, 2023

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.
August 1, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
February 28, 2024

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.
February 26, 2024

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.
February 1, 2024

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-10840098-772.02-2555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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