Clinical trial NCT06590584: Validity and Reliability of the 6-minute Pegboard Ring Test in Obese Individuals
Official title: Validity and Reliability of the 6-minute Pegboard Ring Test in Obese Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obese Patients
Obesity
Obese
Keywords: obesity
exercise test
upper extremity
arm exercise endurance
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese individuals applying to Selçuk University Nutrition and Dietetics Department: Purposive sampling

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?

Detailed description: It was planned as a non-invasive reliability study. The validity and reliability of 6PBRT in obese individuals will be investigated within the scope of the study. In this context, a 1-hour rest break will be given after the first test. Dyspnea and fatigue will be evaluated using the Borg scale and muscle oxygenation, heart rate and blood pressure will be recorded before and after 6PBRT. The second trial of 6PBRT will be performed after the 1-hour rest period. In order to ensure that the patients are stable, the level of dyspnea and fatigue and the initial values of heart rate will be checked before the second trial. All evaluations will be made by the same physiotherapist and an expert physiotherapist will be present during the evaluations.

The smallest sample size of the study was found to be 40 people with a correlation coefficient of 0.95 between the two tests and 90% power at a 95% confidence interval. It is aimed to include 50 people against a 20% drop-out risk.

Shapiro-Wilk test and histogram graphics will be used to check the normality of the data. Demographic and clinical characteristics of the participants will be reported using descriptive statistics. Intraclass correlation coefficient (ICC) with two-way random effects and absolute agreement methods will be used to assess test-retest reliability. The strength of reliability will be interpreted as excellent for ICC value \&amp;amp;amp;gt;0.90. Ninety-five percent Confidence Interval (95% CI) will be calculated to investigate measurement variability.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Six-Minute Pegboard and Ring Test
timeFrame: 1 hour
Secondary outcomes:
measure: Demographic data and personal characteristics
timeFrame: Baseline
measure: Body composition
timeFrame: Baseline
measure: Respiratory muscle strength
timeFrame: Baseline
measure: Extremity Muscle Strength
timeFrame: Baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Selcuklu
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
citation: 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.