NCT03245164

Brief 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

July 31, 2017

Last Update Submit

August 7, 2017

Conditions

Keywords

obese childrenmotor skillsphysiotherapybasketball

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (3)

  • Body Mass Index

    12 weeks

  • Body Fat

    12 weeks

  • Circumferences

    12 weeks

Study Arms (3)

Physiotherapy group exercises

EXPERIMENTAL

This group continued physiotherapy group exercises for 12 weeks.

Other: Physiotherapy group exercises

Basketball program

EXPERIMENTAL

Basketball educaiton was presented for 12 weeks.

Other: Basketball program

Control group

NO INTERVENTION

This group did not continue any physical activity regularly.

Interventions

Physiotherapy exercises had aerobic, balance, strength exercises with music.

Physiotherapy group exercises

Basketball education presented the techniques about playing basketball and basketball games were played.

Basketball program

Eligibility Criteria

Age10 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26881317BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • OZLEM ÜLGER, Assist.Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 10, 2017

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
2 months
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.