- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201158
A Comparison of Activities of Daily Living, Physical Fitness and Quality of Life in Obese and Healthy Adolescents
May 2, 2020 updated by: Ebru Calik Kutukcu, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Obesity among children, adolescents and adults has emerged as one of the most serious public health problems in the 21st century.
There has been a significant decrease in the exercise capacity, physical fitness and activities of daily living of children and adolescents with the increase in the prevalence of obesity over the last decade.
Obesity can cause not only health problems but also psychological effects.
This situation have negative effects on the quality of life.
The effect of these parameters on healthy individuals and obese adolescents will be demonstrated by this study and will guide the rehabilitation of obese adolescents.
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Samanpazari
-
Ankara, Samanpazari, Turkey, 06100
- Hacettepe University
-
-
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
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Modified Shuttle Walk Test
|
|
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.
|
Modified Shuttle Walk Test
|
|
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.
|
Modified Shuttle Walk Test
|
|
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.
|
Modified Shuttle Walk Test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified shuttle walk test.
Time Frame: February 2019-February 2020
|
Maximal exercise capacity
|
February 2019-February 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference, Abdominal circumference, Ratio of waist to hip
Time Frame: February 2019-February 2020
|
Antropometric measurements
|
February 2019-February 2020
|
|
Hand grip strength by hand dynamometer (Jamar).
Time Frame: February 2019-February 2020
|
Peripheral Muscle Strength
|
February 2019-February 2020
|
|
the Glittre Activities of Daily Living (ADL) Test.
Time Frame: February 2019-February 2020
|
Activities of daily living
|
February 2019-February 2020
|
|
the Munich Physical Fitness Test-MFT
Time Frame: February 2019-February 2020
|
Physical Fitness
|
February 2019-February 2020
|
|
Modified push-ups, shuttles and squats as possible for 30 seconds
Time Frame: February 2019-February 2020
|
Peripheral muscle endurance
|
February 2019-February 2020
|
|
The Pediatric Outcomes Data Collection Instrument (PODCI)
Time Frame: February 2019-February 2020
|
Quality of Life
|
February 2019-February 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: 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 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)
June 15, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
December 13, 2019
First Submitted That Met QC Criteria
December 13, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
May 5, 2020
Last Update Submitted That Met QC Criteria
May 2, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO19/60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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