NCT06590584

Brief Summary

Obesity is a major public health problem that causes numerous diseases and problems that threaten human health. The prevalence of obesity has increased worldwide in the last \~50 years and has reached pandemic levels. Similar results are seen in Turkey, and according to the results of the Turkey Health Survey, 20.2% of people aged 15 and over were obese and 35.6% were pre-obese in 2022. Obesity represents a major health problem as it significantly increases the risk of diseases such as type 2 diabetes mellitus, fatty liver disease, hypertension, myocardial infarction, stroke, dementia, osteoarthritis, obstructive sleep apnea and various cancers, thus contributing to a decrease in both quality of life and life expectancy. Obesity is also associated with unemployment, social disadvantages and reduced socio-economic productivity, thus representing an increasing economic burden. Obesity is associated with physiological changes at the muscle level, including a decrease in capillary density and blood flow, thus limiting the supply of oxygen and energy resources. Along with the limited blood flow, muscle cells in obese individuals have a decrease in the relative number and size of mitochondria required for energy supply. This leads to a limitation in upper limb activities. This activity restriction is related to many activities of daily living that involve unsupported upper extremity movements that lead to dyspnea and fatigue in patients with cardiopulmonary disease. Therefore, determining the strength, endurance and exercise capacity of the upper extremities emerges as an important issue in obesity management. One of the tests that serve this purpose is the 6-minute pegboard ring test (6PBRT), which has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma. However, when the literature is examined, it is seen that 6PBRT has not been studied in obese individuals. Therefore, the aim of the study is to investigate the validity and reliability of 6PBRT in obese individuals. The main question it aims to answer is: \- Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients wit obesity?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

August 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 5, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

obesityexercise testupper extremityarm exercise endurance

Outcome Measures

Primary Outcomes (1)

  • Six-Minute Pegboard and Ring Test

    Used to evaluate upper extremity exercise capacity. There are 20 rings on 4 iron bars on the board used, and patients are asked to attach the rings with both hands, first from top to bottom and then from bottom to top. At the end of six minutes, the total number of rings attached is recorded. Before and after the test, heart rate, blood pressure, respiratory rate, dyspnea and fatigue will be evaluated according to the Modified Borg Scale.

    1 hour

Secondary Outcomes (4)

  • Demographic data and personal characteristics

    Baseline

  • Body composition

    Baseline

  • Respiratory muscle strength

    Baseline

  • Extremity Muscle Strength

    Baseline

Interventions

Six-Minute Pegboard and Ring Test: It will be used to evaluate upper extremity exercise capacity. There are 20 rings on 4 iron bars on the board used and patients will be asked to attach the rings with both hands, first from top to bottom and then from bottom to top. At the end of the six minutes, the total number of rings attached will be recorded. Heart rate, blood pressure, respiratory rate, dyspnea and fatigue will be evaluated according to the Modified Borg Scale before and after the test.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese individuals applying to Selçuk University Nutrition and Dietetics Department: Purposive sampling

You may qualify if:

  • BMI value of 30 kg/m2 and above,
  • Ability to ambulate,
  • Being 18 years of age and above,
  • Being a volunteer.

You may not qualify if:

  • Use of anti-obesity medication,
  • Pregnancy,
  • Latent autoimmune diabetes,
  • Chronic renal failure,
  • Active or serious infections,
  • Liver failure,
  • Recent major cardiovascular events,
  • Unstable angina,
  • Heart failure (NYHA III-IV)
  • Respiratory failure, cardiac arrhythmias, neoplastic diseases, and neurological or musculoskeletal disorders that limit testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Selcuklu, 42130, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Hulzebos E, Takken T, Reijneveld EA, Mulder MMG, Bongers BC. Reference Values for Respiratory Muscle Strength in Children and Adolescents. Respiration. 2018;95(4):235-243. doi: 10.1159/000485464. Epub 2018 Jan 17.

    PMID: 29342462BACKGROUND
  • Zhan S, Cerny FJ, Gibbons WJ, Mador MJ, Wu YW. Development of an unsupported arm exercise test in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2006 May-Jun;26(3):180-7; discussion 188-90. doi: 10.1097/00008483-200605000-00013.

    PMID: 16738459BACKGROUND
  • Ozsoy I, Ozcan Kahraman B, Ozsoy G, Ilcin N, Kahraman T, Acar S, Tekin N, Savci S. Determinants of the 6-minute pegboard and ring test as an unsupported upper-extremity exercise capacity measure in older adults with chronic obstructive pulmonary disease. Eur Geriatr Med. 2018 Dec;9(6):863-870. doi: 10.1007/s41999-018-0111-x. Epub 2018 Sep 25.

    PMID: 34674474BACKGROUND
  • Lin X, Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front Endocrinol (Lausanne). 2021 Sep 6;12:706978. doi: 10.3389/fendo.2021.706978. eCollection 2021.

    PMID: 34552557BACKGROUND
  • Greco F, Tarsitano MG, Cosco LF, Quinzi F, Folino K, Spadafora M, Afzal M, Segura-Garcia C, Maurotti S, Pujia R, Pujia A, Buono P, Emerenziani GP. The Effects of Online Home-Based Pilates Combined with Diet on Body Composition in Women Affected by Obesity: A Preliminary Study. Nutrients. 2024 Mar 21;16(6):902. doi: 10.3390/nu16060902.

    PMID: 38542813BACKGROUND
  • Cavuoto LA, Nussbaum MA. The influences of obesity and age on functional performance during intermittent upper extremity tasks. J Occup Environ Hyg. 2014;11(9):583-90. doi: 10.1080/15459624.2014.887848.

    PMID: 24484265BACKGROUND
  • Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, Saglam M, Vardar-Yagli N, Sonbahar-Ulu H, Firat M, Arikan H, Kaya SB, Karakaya G. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022 Jul;59(7):1387-1395. doi: 10.1080/02770903.2021.1930040. Epub 2021 May 31.

    PMID: 33985406BACKGROUND
  • Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.

    PMID: 30814686BACKGROUND
  • Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.

    PMID: 8602410BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

August 1, 2024

Primary Completion

March 28, 2025

Study Completion

June 28, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations