A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents

May 2, 2020 updated by: Ebru Calik Kutukcu, Hacettepe University
It is known that activities of daily living, physical fitness, exercise capacity and quality of life are affected by the obesity. It is aimed to determine the effects obesity on daily living activities, physical fitness, exercise capacity and quality of life in obese adolescents compared to healthy subjects in this study. The relationship between these parameters and the activities of daily living which are less studied in obese adolescents will be evaluated.

Study Overview

Status

Status

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

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

Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century. There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade. Obesity can cause not only health problems but also psychological effects. This situation have negative effects on the quality of life. The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.

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.
Observational

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.
32

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
    • Samanpazari
      • Ankara, Samanpazari, Turkey, 06100
        • Hacettepe 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

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

15 obese adolescents, 15 obese adolescent adolescents and 15 healthy female adolescents and 15 healthy male adolescents compatible with age and sex will be recruited from obese adolescents according to the BMI reference system.

Description

Inclusion Criteria:

Healthy group:

  • Being normal weight according to BMI reference system,
  • Being between the ages of 10-18 and volunteer to participate in the research,
  • Being able to walk and cooperate

Obese Group:

  • Obesity diagnosis according to BMI reference system,
  • Being between the ages of 10-18 and volunteer to participate in the research,
  • Being able to walk and cooperate.

Exclusion Criteria:

Healthy Group:

  • Comorbidities that may affect exercise performance and other physical tests,
  • Having cardiovascular problems, musculoskeletal and neurological disease,
  • Having cognitive or motor limitation or other chronic diseases.

Obese Group:

  • Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • Having musculoskeletal and neurological diseases, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease that may affect exercise performance,
  • Using medication that affects appetite and weight.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Obese Group (Girl)
Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria.Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria.
Diagnostic test: Exercise Capacity
Modified Shuttle Walk Test
Obese Group (Boy)
Diagnosed with the obesity according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Diagnosed with a neurological disease or another clinical diagnosis that may affect the cognitive state, musculoskeletal and neurological disease, symptomatic heart disease, lung disease, diabetes, hypertension and malignant disease, which may affect the performance of exercise and using the drug that affects appetite and weight are the exclusion criteria.
Diagnostic test: Exercise Capacity
Modified Shuttle Walk Test
Control Group (Girl)
Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria.
Diagnostic test: Exercise Capacity
Modified Shuttle Walk Test
Control Group (Boy)
Being normal weight according to body mass index reference system, being 10-18 years old, being volunteer for the research and able to walk and cooperate are the inclusion criteria. Having comorbidities which may affect exercise performance and other physical tests, diagnosed with the cardiovascular problems, musculoskeletal and neurological diseases, cognitive or motor limitation or other chronic diseases are exclusion criteria.
Diagnostic test: Exercise Capacity
Modified Shuttle Walk Test

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 Modified shuttle walk test.
Time Frame: February 2019-February 2020
Maximal exercise capacity
February 2019-February 2020

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
Waist circumference, Abdominal circumference, Ratio of waist to hip
Time Frame: February 2019-February 2020
Antropometric measurements
February 2019-February 2020
Hand grip strength by hand dynamometer (Jamar).
Time Frame: February 2019-February 2020
Peripheral Muscle Strength
February 2019-February 2020
the Glittre Activities of Daily Living (ADL) Test.
Time Frame: February 2019-February 2020
Activities of daily living
February 2019-February 2020
the Munich Physical Fitness Test-MFT
Time Frame: February 2019-February 2020
Physical Fitness
February 2019-February 2020
Modified push-ups, shuttles and squats as possible for 30 seconds
Time Frame: February 2019-February 2020
Peripheral muscle endurance
February 2019-February 2020
The Pediatric Outcomes Data Collection Instrument (PODCI)
Time Frame: February 2019-February 2020
Quality of Life
February 2019-February 2020

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.
Hacettepe 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 Chair: Ceren Iskenderoglu, Physical Therapist, Hacettepe University
  • Study Chair: Deniz Inal Ince, Professor, Hacettepe University
  • Study Chair: Melda Saglam, Associate Professor, Hacettepe University
  • Study Chair: Naciye Vardar Yagli, Associate Professor, Hacettepe University
  • Study Chair: Hazal Sonbahar Ulu, MSc, Hacettepe University
  • Study Chair: Melis Pehlivanturk Kizilkan, MD, Hacettepe 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.
June 15, 2019

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.
April 1, 2020

Study Completion (Actual)

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.
April 1, 2020

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).
December 13, 2019

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.
December 13, 2019

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.
December 17, 2019

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 5, 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.
May 2, 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.
May 1, 2020

More Information

Terms related to this study

Keywords

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.
  • GO19/60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings