The Effects of Group Exercise and Basketball on Obese Children

August 7, 2017 updated by: Eastern Mediterranean University

Comparing the Effects of Group Exercise and Basketball on Body Composition and Motor Skills of Obese Children

This study aimed to compare the effects of group exercises under physiotherapist control and basketball program on body composition and motor skills of obese children. 45 obese children aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and control group (n:15). The children were assessed before and after 12-week study duration. Body Mass Index (BMI), the percentage of body fat, and circumference values of the children were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used to determine motor skills of children.

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

The roles of active physiotherapy programs and sport programs on the management of the problems arising from childhood obesity should be determined. Although the effects of exercise and various sport branches on decrease obesity and obesity related problems, the effects of group exercises managed by physiotherapists and team sports on body composition and motor skills of obese children are not clear so health professionals may have difficulties while suggesting better physical activity for this population.

Thus, body composition and motor skills of the included children were recorded at the beginning. They were then grouped into three in order to compare the effects of group exercises and basketball. Children in the control group did not participate in any of them. Intervention lasted 12 weeks so they were then taken to the assessments at the end of this duration.

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.
45

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

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 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children who were born in 2006 (10 years old),
  • children whose BMI values were ≥95. Percentiles,
  • a report which was given by a doctor to state that the child could participate in aerobic exercise,
  • children who had not continued to a diet program for 3 months,
  • children who had not participated regularly in any sport or exercise for 6 months.

Exclusion Criteria:

  • children who had any disease requiring use of medicine,
  • children who had any pain to prevent doing exercise or sport,
  • children who had any neuromuscular 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: 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: Physiotherapy group exercises
This group continued physiotherapy group exercises for 12 weeks.
Other: Physiotherapy group exercises
Physiotherapy exercises had aerobic, balance, strength exercises with music.
Experimental: Basketball program
Basketball educaiton was presented for 12 weeks.
Other: Basketball program
Basketball education presented the techniques about playing basketball and basketball games were played.
No Intervention: Control group
This group did not continue any physical activity regularly.

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
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
Time Frame: 12 weeks
The BOTMP-BF test was used to determine the motor skills of the children. It is a popularly used test to specify the level of motor skills of children. Touching nose with index fingers as eyes closed and pivoting thumbs and index fingers were scored for bilateral coordination. Walking forward heel-to-toe on a line for balance, push-up numbers for strength,and number of one-legged side hop in a given duration for speed-agility were scored. Filling in a star, drawing a line through a path, and copying shapes were scored to determine fine motor integration. Stringing blocks in a given time duration was scored for manual dexterity. Catching a Tossed-ball with one hand and dribbling a ball with alternative hands were scored for upper limb coordination. Scoring is explained in the booklet of BOTMP-BF. A total score of this test was acquired.
12 weeks

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
Body Mass Index
Time Frame: 12 weeks
Body Mass Index (BMI) was calculated as weight (in kilograms) divided by height (in meters) squared (kg/m2).
12 weeks
Body Fat
Time Frame: 12 weeks
Body fat was determined by skinfold measurements (in milimeters). Lange Skinfold caliper (Cambridge Scientific Industries, Cambridge, MD) was used to determine the percentage of body fat. Triceps, biceps, chest, sucscapula, abdominal, and suprailiac regions were measured. All measurements were taken only from the right side of their body. During these measurements, all children remained standing. Slaughter's equation was used to calculate the percentage of body fat.
12 weeks
Circumferences
Time Frame: 12 weeks
Arm, waist, chest, and hip circumferences were measured using an inelastic tape while the children were standing and breathing normally. Right arm was taken as a reference for circumference. Values were recorded in centimeters.
12 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.
Eastern Mediterranean University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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 Director: OZLEM ÜLGER, Assist.Prof., Hacettepe 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.
September 1, 2015

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.
July 1, 2016

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.
July 1, 2016

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 31, 2017

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.
August 7, 2017

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 10, 2017

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.
August 10, 2017

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.
August 7, 2017

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.
August 1, 2017

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.
  • EasternMUZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Body Mass Indexes of children who continued 4th class in all primary schools in the study city were recorded. The parents of children who had 95.> percentiles of BMI values were then invited to the study and the participants who accepted the invitation were assessed. They were then evaluated and randomly assigned to three groups. The number for each group was determined by power analysis.

IPD Sharing Time Frame

2 months

IPD Sharing Access Criteria

Primary schools of the city where the study would take place in were analysed for the appropriate body mass indexes. The parents were then invited to participate in the study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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