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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392920
Other study ID # 2022/37
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 8, 2022
Est. completion date November 2, 2022

Study information

Verified date July 2022
Source Istanbul University-Cerrahpasa
Contact Nesrine Benkhalifa, PT
Phone +905418191403
Email nesrine.benkhalifa@ogr.iuc.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date November 2, 2022
Est. primary completion date October 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
assessment study
there is no intervention in this study

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

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. Review. — View Citation

Özgen IT, Çakir E, Torun E, Güles 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Secondary 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 . Baseline
Secondary Hip circumference Hip circumference will be measured parallel to the ground with a tape measure at the level of the trochanter major. Baseline
Secondary Body fat percentage Body fat percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands). Baseline
Secondary Body muscle percentage Body muscle percentage will be analyzed with the BIA instrument (Tanita MC 780 MA Body Composition Analysis, Amsterdam, Netherlands). Baseline
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