- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392920
Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents
July 7, 2022 updated by: nesrine benkhalifa, Istanbul University - Cerrahpasa (IUC)
Obese individuals need to be evaluated comprehensively before exercise programs are determined.
Determination of exercise intolerance is important for the detection of functional limitations.
One minute sit to stand test (1MSTST) can be used as an alternative to cardiopulmonary exercise tests (CPET) or field tests.
It is easy to use, quick to apply, valid and reliable, and applicable even in small areas.
In addition, it is a simple assessment adequate for children's needs and behaviors and can be easily applied both in the clinic and at home, making it easier to use in children.
Studies have shown that 1MSTST is a valid test in chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, and, healthy children and adolescents.
However, no study has been found regarding the validity of its use in obese children and adolescents.The aim of our study is to investigate the validity and reliability of 1MSTST in overweight-obese children and adolescents.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nesrine Benkhalifa, PT
- Phone Number: +905418191403
- Email: nesrine.benkhalifa@ogr.iuc.edu.tr
Study Contact Backup
- Name: Cigdem Emirza, PT, MSc
- Phone Number: +902123115136
- Email: cgdemrza@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34500
- Recruiting
- Istanbul University-Cerrahpasa
-
Contact:
- Nesrine Benkhalifa, PT
- Phone Number: +905418191403
- Email: noussabk93@gmail.com
-
-
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
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Overweight or obese children and adolescents
Description
Inclusion Criteria:
- Being in the 8-18 age range.
- Being overweight (between 85 and 95 according to the Body Mass Index percentile).
- Being obese (over 95 based on the Body Mass Index percentile).
- Not doing any vigorous exercise two hours before the test.
Exclusion Criteria:
- History of hospitalization in the last month for a reason that may affect physical performance.
- Having neurological, musculoskeletal disease that prevents exercise tests.
- Uncontrollable medical conditions (Cardiovascular, pulmonary disease, etc.).
- Visual and/or vestibular disorders.
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese children and adolescents
Obese children and adolescent patients
|
there is no intervention in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1 min sit to stand test
Time Frame: Baseline
|
Only a chair and a stopwatch are needed to apply the test.
It is recommended to use a chair with a height of 45-48 cm, preferably against the wall, fixed, without arm support.
The patients will sit with their feet flat on the ground and cross their arms over the chest.
The patient will be asked to get up from the chair and sit down as fast as he/she can for 1 minute.
The number of standing up will be recorded.
|
Baseline
|
|
6 minute walk test
Time Frame: Baseline
|
The patient's exercise capacity will be determined by the six minute walk test.
The test will be applied in a corridor 30 meters long.
The patient will be asked to walk as fast as possible for six minutes.
The patient can stop during the test if they needed.
The total time, the number of times it has stopped and the total distance traveled will be recorded.
Oxygen saturation, heart rate, and blood pressure measurements will be taken before and after the test.
According to the modified Borg scale, dyspnea, leg fatigue and general fatigue will be questioned.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference
Time Frame: Baseline
|
Waist circumference will be measured using a tape measure from the midpoint between the lowest rib and the iliac crest, when the patient is standing .
|
Baseline
|
|
Hip circumference
Time Frame: Baseline
|
Hip circumference will be measured parallel to the ground with a tape measure at the level of the trochanter major.
|
Baseline
|
|
Body fat percentage
Time Frame: Baseline
|
Body fat percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).
|
Baseline
|
|
Body muscle percentage
Time Frame: Baseline
|
Body muscle percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Goksen Kuran Aslan, PT, phD, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.
- Ozgen IT, Cakir E, Torun E, Gules A, Hepokur MN, Cesur Y. Relationship Between Functional Exercise Capacity and Lung Functions in Obese Chidren. J Clin Res Pediatr Endocrinol. 2015 Sep;7(3):217-21. doi: 10.4274/jcrpe.1990.
Helpful Links
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 (Anticipated)
July 8, 2022
Primary Completion (Anticipated)
October 2, 2022
Study Completion (Anticipated)
November 2, 2022
Study Registration Dates
First Submitted
May 15, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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