Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590584
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Validity and Reliability of the 6-minute Pegboard Ring Test in Obese Individuals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validity and Reliability of the 6-minute Pegboard Ring Test in Obese Individuals
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 202 of people aged 15 and over were obese and 356 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
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 095 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 ampampampgt090 Ninety-five percent Confidence Interval 95 CI will be calculated to investigate measurement variability
The smallest sample size of the study was found to be 40 people with a correlation coefficient of 095 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 ampampampgt090 Ninety-five percent Confidence Interval 95 CI will be calculated to investigate measurement variability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None