NCT04201158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

December 13, 2019

Last Update Submit

May 2, 2020

Conditions

Keywords

Physical FitnessExercise CapacityActivities of Daily LivingQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The Modified shuttle walk test.

    Maximal exercise capacity

    February 2019-February 2020

Secondary Outcomes (6)

  • Waist circumference, Abdominal circumference, Ratio of waist to hip

    February 2019-February 2020

  • Hand grip strength by hand dynamometer (Jamar).

    February 2019-February 2020

  • the Glittre Activities of Daily Living (ADL) Test.

    February 2019-February 2020

  • the Munich Physical Fitness Test-MFT

    February 2019-February 2020

  • Modified push-ups, shuttles and squats as possible for 30 seconds

    February 2019-February 2020

  • +1 more secondary outcomes

Study Arms (4)

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

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

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

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

Interventions

Exercise CapacityDIAGNOSTIC_TEST

Modified Shuttle Walk Test

Control Group (Boy)Control Group (Girl)Obese Group (Boy)Obese Group (Girl)

Eligibility Criteria

Age10 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details15 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 17, 2019

Study Start

June 15, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations