Childhood ObesityNCT03245164
The Effects of Group Exercise and Basketball on Obese Children
A study testing Physiotherapy group exercises and Basketball program in people with Childhood Obesity and Physical Activity, run by Eastern Mediterranean University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 to 10 years
- Conditions the study is for
- Childhood Obesity, Physical Activity
- What is being tested?
- Physiotherapy group exercises and Basketball program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity, Physical Activity
- Being tested
- Physiotherapy group exercises, Basketball program
- Keywords
- obese children, motor skills, physiotherapy, basketball
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy group exercisesOther
Physiotherapy exercises had aerobic, balance, strength exercises with music.
Basketball programOther
Basketball education presented the techniques about playing basketball and basketball games were played.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group exercises | Experimental | This group continued physiotherapy group exercises for 12 weeks. Receives: Other: Physiotherapy group exercises |
| Basketball program | Experimental | Basketball educaiton was presented for 12 weeks. Receives: Other: Basketball program |
| Control group | No intervention | This group did not continue any physical activity regularly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF)
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.
Measured: 12 weeks
Secondary outcomes (3)
Body Mass Index
Body Mass Index (BMI) was calculated as weight (in kilograms) divided by height (in meters) squared (kg/m2).
Measured: 12 weeks
Body Fat
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.
Measured: 12 weeks
Circumferences
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor
- Investigators
- OZLEM ÜLGER, Assist.Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245164
- Sponsor's protocol ID
- EasternMUZ
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Alberga AS, Prud'homme D, Sigal RJ, Goldfield GS, Hadjiyannakis S, Phillips P, Malcolm J, Ma J, Doucette S, Gougeon R, Wells GA, Kenny GP. Effects of aerobic training, resistance training, or both on cardiorespiratory and musculoskeletal fitness in adolescents with obesity: the HEARTY trial. Appl Physiol Nutr Metab. 2016 Mar;41(3):255-65. doi: 10.1139/apnm-2015-0413. Epub 2015 Nov 9.
PubMed 26881317
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Group Exercise and Basketball on Body Composition and Motor Skills of Obese Children
- ClinicalTrials.gov ID
- NCT03245164
- Acronym / sponsor ID
- EasternMUZ
- Conditions
- Childhood Obesity, Physical Activity
- Keywords
- obese children, motor skills, physiotherapy, basketball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group exercises | Experimental | Other: Physiotherapy group exercisesThis group continued physiotherapy group exercises for 12 weeks. |
| Basketball program | Experimental | Other: Basketball programBasketball educaiton was presented for 12 weeks. |
| Control group | No intervention | –This group did not continue any physical activity regularly. |
Who may qualify
- Ages
- 10 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy group exercisesPhysiotherapy exercises had aerobic, balance, strength exercises with music. | Other | Physiotherapy group exercises |
| Basketball programBasketball education presented the techniques about playing basketball and basketball games were played. | Other | Basketball program |
Primary outcome
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.
3 secondary outcomes
Body Mass Index
Time frame: 12 weeks
Body Fat
Time frame: 12 weeks
Circumferences
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 26881317Alberga AS, Prud'homme D, Sigal RJ, Goldfield GS, Hadjiyannakis S, Phillips P, Malcolm J, Ma J, Doucette S, Gougeon R, Wells GA, Kenny GP. Effects of aerobic training, resistance training, or both on cardiorespiratory and musculoskeletal fitness in adolescents with obesity: the HEARTY trial. Appl Physiol Nutr Metab. 2016 Mar;41(3):255-65. doi: 10.1139/apnm-2015-0413. Epub 2015 Nov 9.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OZLEM ÜLGER, Assist.Prof. study director
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy group exercises and Basketball program in people with Childhood Obesity and Physical Activity, run by Eastern Mediterranean University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.