NCT05571085

Brief Summary

The aim of this study is to examine the effects of core stabilization and PNF exercises on core muscle activation in obese children.In the study, the initial sample size was calculated as 66 people, under the assumptions that the comparisons between groups would be made with one-way analysis of variance (ANOVA), 3 groups would be included in the study, α= 0.05, β= 0.20 and the effect size would be f= 0.40. The study will be conducted on children between the ages of 10-13 who have a BMI value above the 95% percentile according to age and gender.After recording the sociodemographic information of the individuals, body composition, core muscle activation level, lumbar region muscle endurance, lumbar joint position sense, body image, static and dynamic balances, level of enjoyment of physical activity, physical activity level and pediatric quality of life scale before treatment, 8 weeks of treatment will be measured by the evaluator at the end of the 12-week follow-up period. The level of core muscle activation will be used as the primary outcome measure in the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

October 28, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

June 25, 2022

Last Update Submit

October 4, 2022

Conditions

Keywords

core muscle activationExerciseCore stabilitypediatrics

Outcome Measures

Primary Outcomes (1)

  • Core muscle strength

    Core muscle strength will be measured using a simple and feasible equipment, Pressure Biofeedback (Chattanooga Group Inc., Hixson, TN, USA).

    Change from baseline at 8 weeks and 12 weeks after the intervention.

Secondary Outcomes (7)

  • McGill Core Endurance Tests

    Change from baseline at 8 weeks and 12 weeks after the intervention.

  • Joint Position Sense

    Change from baseline at 8 weeks and 12 weeks after the intervention.

  • Children's Body Image Scale

    change from baseline at 8 weeks and 12 weeks after the intervention

  • Dynamic Balance test

    change from baseline at 8weeks and 12 weeks after the intervention

  • Static Balance Test

    change from baseline at 8weeks and 12 weeks after the intervention

  • +2 more secondary outcomes

Study Arms (3)

Core Stability Exercises group

EXPERIMENTAL

Core stabilization exercises will be performed based on the program recommended by Jeffrey. Each session will take 40-50 minutes. The program consists of a 5-minute warm-up, 40-minute main exercise and a 5-minute cool-down period. Children will be taught the abdominal cupping technique during the first two weeks of the exercises.

Other: Core Stability Exercises

PNF Exercise Program

OTHER

PNF exercises will consist of a 5-minute warm-up, 40-minute main exercise and a 5-minute cool-down period, with each session lasting 40-50 minutes. Individuals will be taught the abdominal cupping technique during the first two weeks of the program.

Other: PNF Exercise Program

Control Group

NO INTERVENTION

No treatment program was applied. As a result of the study, an effective exercise program will be recommended to the participants.

Interventions

Core stabilization exercises will be performed based on the program recommended by Jeffrey. Each session will take 40-50 minutes. The program consists of a 5-minute warm-up, 40-minute main exercise and a 5-minute cool-down period.

Core Stability Exercises group

PNF exercises will consist of a 5-minute warm-up, 40-minute main exercise and a 5-minute cool-down period, with each session lasting 40-50 minutes.

PNF Exercise Program

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having a BMI value over the 95% percentile according to age and gender,
  • Not included in an ongoing diet program for the last 3 months,
  • Children who have not participated in an exercise or sports program for the last 6 months will be included.

You may not qualify if:

  • Having a chronic disease that requires continuous drug use,
  • Having chronic pain that will prevent them from exercising,
  • Having a disease of neuromuscular origin,
  • Having spinal anomaly,
  • Having a history of spinal surgery,
  • Children with spinal and sacroiliac joint dysfunction, history of injury or trauma will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selma Uzuner

Famagusta, 99628, Cyprus

RECRUITING

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • SELMA UZUNER, MSc

    selmauzuner10@gmail.com

    PRINCIPAL INVESTIGATOR
  • EMİNE HANDAN TÜZÜN, PROF

    selmauzuner10@gmail.com

    STUDY DIRECTOR

Central Study Contacts

SELMA UZUNER, MSc

CONTACT

Serpil MIHÇIOĞLU, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. Physiotherapist

Study Record Dates

First Submitted

June 25, 2022

First Posted

October 7, 2022

Study Start

October 28, 2021

Primary Completion

November 28, 2022

Study Completion

December 3, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations