Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588959
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
6-minute Pegboard Ring Test in Patients with Scleroderma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validity and Reliability of the 6-minute Pegboard Ring Test in Patients with Scleroderma
Status:
NOT_YET_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:
The aim of this observational study was to evaluate the reliability and validity of the 6-minute pegboard and ring test 6PBRT in patients with systemic sclerosis The main question it aims to answer is
- Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients with systemic sclerosis Participants will repeat the 6PBRT 2 times 1 hour apart In addition respiratory muscle strength MIP-MEP upper extremity muscle strength hand dynanometer and hand-held dynanometer muscle oxygen saturation Moxy Monitor Device will be evaluated
- Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients with systemic sclerosis Participants will repeat the 6PBRT 2 times 1 hour apart In addition respiratory muscle strength MIP-MEP upper extremity muscle strength hand dynanometer and hand-held dynanometer muscle oxygen saturation Moxy Monitor Device will be evaluated
Detailed Description:
Upper extremity functions are of great importance especially activities of daily living There are opinions that the impairment of the upper extremity in scleroderma is greater than that of the lower extremity and affects the functional status of individuals more This activity limitation is related to many activities of daily living including unsupported upper limb movements that lead to dyspnea and fatigue in patients with cardiopulmonary disease Therefore determining the strength endurance and exercise capacity of the upper extremities is an important issue in scleroderma management One of the tests that serves this purpose is the 6PBRT which has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma
It was planned as a non-interventional reliability study The study will investigate the validity and reliability of 6PBRT in patients with scleroderma In this context a 1-hour rest break will be given after the first test Dyspnea and fatigue will be assessed using the Borg scale and muscle oxygenation heart rate and blood pressure will be recorded before and after 6PBRT After the 1-hour rest period the second trial of 6PBRT will be performed The level of dyspnea and fatigue and initial values of heart rate will be checked before the second trial to ensure that patients are stable All assessments will be performed by the same physiotherapist In addition participants will be assessed for respiratory muscle strength upper limb muscle strength and muscle oxidation during the performance test
The smallest sample size of the study was 40 subjects with a correlation coefficient of 095 between the two tests and 90 power at 95 confidence interval 50 subjects are aimed to be recruited against a 20 drop-out risk Shapiro-Wilk test and histogram plots will be used to check the normality of the data Demographic and clinical characteristics of the participants will be reported using descriptive statistics Two-way random effects and absolute agreement methods and intraclass correlation coefficient ICC will be used to assess test-retest reliability Reliability strength will be interpreted as excellent for an ICC value gt090 The 95 Confidence Interval 95 CI will be calculated to investigate measurement variability
It was planned as a non-interventional reliability study The study will investigate the validity and reliability of 6PBRT in patients with scleroderma In this context a 1-hour rest break will be given after the first test Dyspnea and fatigue will be assessed using the Borg scale and muscle oxygenation heart rate and blood pressure will be recorded before and after 6PBRT After the 1-hour rest period the second trial of 6PBRT will be performed The level of dyspnea and fatigue and initial values of heart rate will be checked before the second trial to ensure that patients are stable All assessments will be performed by the same physiotherapist In addition participants will be assessed for respiratory muscle strength upper limb muscle strength and muscle oxidation during the performance test
The smallest sample size of the study was 40 subjects with a correlation coefficient of 095 between the two tests and 90 power at 95 confidence interval 50 subjects are aimed to be recruited against a 20 drop-out risk Shapiro-Wilk test and histogram plots will be used to check the normality of the data Demographic and clinical characteristics of the participants will be reported using descriptive statistics Two-way random effects and absolute agreement methods and intraclass correlation coefficient ICC will be used to assess test-retest reliability Reliability strength will be interpreted as excellent for an ICC value gt090 The 95 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