NCT05392920

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 15, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

May 15, 2022

Last Update Submit

July 7, 2022

Conditions

Keywords

obese patientfunctional testreliabilityvalidity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Waist circumference

    Baseline

  • Hip circumference

    Baseline

  • Body fat percentage

    Baseline

  • Body muscle percentage

    Baseline

Study Arms (1)

Obese children and adolescents

Obese children and adolescent patients

Other: assessment study

Interventions

there is no intervention in this study

Obese children and adolescents

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Overweight or obese children and adolescents

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30489442BACKGROUND
  • 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.

    PMID: 12091180BACKGROUND
  • 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.

    PMID: 26831556BACKGROUND

Related Links

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Goksen Kuran Aslan, PT, phD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Cigdem Emirza, PT, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 26, 2022

Study Start

July 8, 2022

Primary Completion

October 2, 2022

Study Completion

November 2, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations