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Obese PatientsNCT06590584

Validity and Reliability of the 6-minute Pegboard Ring Test in Obese Individuals

An observational study of Obese Patients and Obesity, run by Selcuk University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obese Patients, Obesity, Obese
What is being tested?
Patients with obesity
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2024to 28 Jun 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Use of anti-obesity medication,
  • Pregnancy,
  • Latent autoimmune diabetes,
  • Chronic renal failure,
  • Active or serious infections,
  • Liver failure,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

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

    Konya, Selcuklu, 42130

    Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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?
Read the 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 \>0.90. Ninety-five percent Confidence Interval (95% CI) will be calculated to investigate measurement variability.

Being tested
Patients with obesity
Keywords
obesity, exercise test, upper extremity, arm exercise endurance
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with obesityOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 hour

Secondary outcomes (4)

  1. Demographic data and personal characteristics

    Demographic information such as sociodemographic characteristics and medications used, comorbidities, education level, occupation, smoking and alcohol use, CV and family history of the individuals included in the study will be recorded in a previously prepared form.

    Measured: Baseline

  2. Body composition

    Body mass and body composition will be measured with the help of Tanita brand device using bioelectrical impedance method. The variables to be evaluated with this device are; body mass index (BMI = body mass: (kg)/height2 (m)2), fat mass expressed as a percentage of body mass (pFM), fat-free mass (FFM) expressed in kilograms and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. The measurements will be recorded on the previously prepared form.

    Measured: Baseline

  3. Respiratory muscle strength

    They are easy to apply and simple measurements. Maximal voluntary inspiratory and expiratory pressures (MIP and MEP) are the most commonly used noninvasive methods for measuring respiratory muscle strength. They are based on the Müller (maximal inspiration) and Valsalva (maximal expiration) principles. MIP and MEP data will be measured and collected with an intraoral pressure measuring device and the data will be recorded on a previously prepared form.

    Measured: Baseline

  4. Extremity Muscle Strength

    Hand grip, elbow flexion, shoulder flexion and abduction muscle strengths will be measured with a dynamometer.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Aug 2024
  3. Primary completion28 Mar 2025 (estimated)
  4. Study completion28 Jun 2025 (estimated)

Resources

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
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06590584
Sponsor's protocol ID
SelcukU_PT_PegboardRingTest
Status last verified
Sep 2024
First submitted
5 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29342462

  • 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.

    PubMed 16738459

  • 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.

    PubMed 34674474

  • 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.

    PubMed 34552557

  • 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.

    PubMed 38542813

  • 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.

    PubMed 24484265

  • 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.

    PubMed 33985406

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

    PubMed 30814686

  • 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.

    PubMed 8602410

Questions about this trial

What is this clinical trial studying?

An observational study of Obese Patients and Obesity, run by Selcuk University 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 10 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 19 Sep 2024. 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 Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-Minute Pegboard and Ring Test (time frame: 1 hour). 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 NCT06590584, which also lists 9 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 19 Sep 2024.

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