Comparison of the Effects of Two Different Exercise Programs in Obese Adolescents

July 27, 2020 updated by: Saime Nilay Arman, Istanbul University

Comparison of the Effects of Two Different Exercise Programs on Balance, Posture and Lower Extremity Functions in Obese Adolescents

Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.

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 (Anticipated)

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, 34740
        • Istanbul University-Cerrahpasa

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

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months

Exclusion Criteria:

  • Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • 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: Balance exercise group
Balance exercises will be carried out with a physiotherapist.
Other: Balance exercise group
Balance exercises will be carried out with a physiotherapist
EXPERIMENTAL: Strengthening exercise group
Strengthening exercises will be performed with a physiotherapist.
Other: Balance exercise group
Balance exercises will be carried out with a physiotherapist

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
The six-minute walking test
Time Frame: Change from baseline to 8 weeks, follow up at two months
The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.
Change from baseline to 8 weeks, follow up at two months

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
Sit Up Stand Test
Time Frame: Change from baseline to 8 weeks, follow up at two months
It reflects the individuals' lower limb muscle strength and functional capacities. For the test, the individual is allowed to sit on the 43.18 cm high chair in the middle of the chair with his back straight, with his feet on the ground and his arms crossed in front of his chest (right hand left shoulder, left hand right shoulder). When the individual is in this position, the test is started with the start command and the number of complete departures that he has made for 30 seconds constitutes the score of the individual. The lower extremity functions of the cases will be evaluated by sit and test.
Change from baseline to 8 weeks, follow up at two months
Evaluation of Muscle Force
Time Frame: Change from baseline to 8 weeks, follow up at two months
Muscle strength tests are performed to determine the ability to provide strength and stability. One of the methods used in the evaluation of muscle strength is the dynamometer. Compared to isokinetic devices, hand-held dynamometers are considered as a reliable and valid tool for evaluating muscle strength in the clinic due to their easy transportation, cost and small size. The lower extremity muscle strength of the cases will be evaluated with MicroFet 2 brand dynamometer.
Change from baseline to 8 weeks, follow up at two months
10 Step Down Time Test
Time Frame: Change from baseline to 8 weeks, follow up at two months
All cases are asked to go up to 10 digits (14x28x120 cm) as fast as possible. Step-up time is measured in seconds with a stopwatch. The measurement is repeated three times and the score is recorded by taking the average of the three measurements.
Change from baseline to 8 weeks, follow up at two months
Functional Forward Reach Test
Time Frame: Change from baseline to 8 weeks, follow up at two months
Functional reach test will be used to evaluate the balance of the cases. The person is asked to stand sideways in a position where the right arm does not touch a tape measure attached to the wall at shoulder height. When the arm is at 90 ° flexion, it is requested to hold the arm in parallel with the tape measure without extending it forward. The distance between the shoulder and the 3rd fingertip is measured. Then, the maximum distance at which he can extend his arm horizontally is measured. The difference between the two positions is calculated in centimeters.
Change from baseline to 8 weeks, follow up at two months
Flamingo Balance Test
Time Frame: Change from baseline to 8 weeks, follow up at two months
Flamingo Balance Test is used to determine the static balance of the cases. According to this test, the patients stand in balance by standing with the side of the tested side on a wooden balance instrument 50 centimeters long, 4 centimeters high and 3 centimeters wide. He bends his other foot from his knee and holds it with his hand on the same side. While the patient is in balance with one foot in this way, the time begins and tries to stay in balance for 1 minute. The time is stopped when the balance is disturbed (leaving it while holding the foot, falling from the board to the ground, touching the ground with any part of its body, etc.). When the patient goes up to the balance device and restores his balance, the time continues from where he left off. The test continues for a minute. When the time is completed, each patient's attempt to balance (after falling) is counted, and this number is recorded as the patient's score at the end of the test when one minute has been completed.
Change from baseline to 8 weeks, follow up at two months
One Leg Stand Test
Time Frame: Change from baseline to 8 weeks, follow up at two months
It is a test in which the patient's right and left extremity is measured in balance time and evaluates the static balance. If the patient can stand on one foot for 180 seconds, the test is considered complete. In our study, one foot standing test will be performed in accordance with the criteria specified in the literature. Patients are asked to stand as much as possible on one foot with their eyes open and in a standing position, and the time they are stopped is measured in seconds, measured by a stopwatch. An experiment is made before registration and then the test is repeated 3 times. No oral stimuli are given during the test. The stopwatch is stopped when the patient's foot in the air touches the ground or when the patient loses his standing position (47). Static balance assessment of the cases will be evaluated by standing on one leg test.
Change from baseline to 8 weeks, follow up at two months
Bioelectrical Impedance Analysis
Time Frame: Change from baseline to 8 weeks, follow up at two months
The method is based on the difference between the lean tissue mass and the electrical permeability of the oil. In the method, weak electrical current impedance is measured. Hand-to-hand, hand-to-foot, foot-to-foot measurements can be made with different BIA analysis tools. Many other data are obtained, such as the amount of body fat, lean body mass, body water, and the distribution of fat in various parts of the body. It is a practical, easy to use and recommended method. The muscle, fat and water ratio of the cases will be evaluated with the InBody Bioelectric Impedance Device.
Change from baseline to 8 weeks, follow up at two months
PostureScreen Mobile
Time Frame: Change from baseline to 8 weeks, follow up at two months
There are different systems that use digital photographs and software analysis in posture evaluation. PostureScreen Mobile (posture analysis / body composition / motion evaluation software) is a valid and reliable application developed to evaluate posture with the help of a camera system on devices with iOS and Android systems. Posture evaluation is done through the program using the PostureScreen Mobile application. On the front and side photographs of the individual, the specific points determined in the software are marked using the touch screen, and according to these points, the values of the postural disorder and the degree of the disorder are calculated and reported for each patient in "centimeters" by software. Posture evaluation of the cases will be done with PostureScreen Mobile.
Change from baseline to 8 weeks, follow up at two months

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 University

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.
February 27, 2020

Primary Completion (ANTICIPATED)

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.
July 30, 2020

Study Completion (ANTICIPATED)

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.
September 30, 2021

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 27, 2020

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 27, 2020

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.
July 29, 2020

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.
July 29, 2020

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.
July 27, 2020

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.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 02/10/2019-149844

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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