ObeseNCT05392920
Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents
An observational study of Obese and Child Obesity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Child Obesity, Adolescent Obesity
- What is being tested?
- assessment study
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2022to 2 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Overweight or obese children and adolescents
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, 34500
Nesrine Benkhalifa, PT, +905418191403, noussabk93@gmail.com
About this study
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.
- Conditions
- Obese, Child Obesity, Adolescent Obesity, Exercise Capacity
- Being tested
- assessment study
- Keywords
- obese patient, functional test, reliability, validity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment studyOther
there is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Obese children and adolescents | Obese children and adolescent patients Receives: Other: assessment study |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 min sit to stand test
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.
Measured: Baseline
6 minute walk test
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.
Measured: Baseline
Secondary outcomes (4)
Waist circumference
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 .
Measured: Baseline
Hip circumference
Hip circumference will be measured parallel to the ground with a tape measure at the level of the trochanter major.
Measured: Baseline
Body fat percentage
Body fat percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).
Measured: Baseline
Body muscle percentage
Body muscle percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start8 Jul 2022 (estimated)
- Primary completion2 Oct 2022 (estimated)
- Study completion2 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nesrine benkhalifa, Istanbul University - Cerrahpasa
- Investigators
- Goksen Kuran Aslan, PT, phD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392920
- Sponsor's protocol ID
- 2022/37
- Status last verified
- Jul 2022
- First submitted
- 15 May 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30489442ATS 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.
PubMed 12091180Ozgen 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.
PubMed 26831556
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents
- ClinicalTrials.gov ID
- NCT05392920
- Acronym / sponsor ID
- 2022/37
- Conditions
- Obese, Child Obesity, Adolescent Obesity, Exercise Capacity
- Keywords
- obese patient, functional test, reliability, validity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 8 Jul 2022 (estimated)
- Primary completion
- 2 Oct 2022 (estimated)
- Study completion
- 2 Nov 2022 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese children and adolescents | – | Other: assessment studyObese children and adolescent patients |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Overweight or obese children and adolescents
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment studythere is no intervention in this study | Other | Obese children and adolescents |
Primary outcome
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.
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.
4 secondary outcomes
Waist circumference
Time frame: Baseline
Hip circumference
Time frame: Baseline
Body fat percentage
Time frame: Baseline
Body muscle percentage
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 30489442Bohannon 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 26831556Ozgen 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goksen Kuran Aslan, PT, phD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese and Child Obesity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesrine Benkhalifa, PT (+905418191403, nesrine.benkhalifa@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 min sit to stand test (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392920, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.