Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479252
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-14
Brief Title:
Comparing Centre-based Remotely Supervised and Self-administered STS Tests in Individuals With CRD
Sponsor:
West Park Healthcare Centre
Organization:
West Park Healthcare Centre
Study Overview
Official Title:
Comparing Centre-based Remotely Supervised and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STS24
Brief Summary:
Despite evidence on the psychometric properties of sit-to-stand STS tests in chronic respiratory disease CRD populations most studies have been conducted face-to-face Given the recent emphasis on virtual pulmonary rehabilitation VPR there is a need to identify reliable and valid exercise tests that can be delivered in home-based settings either supervised remotely or self-administered by patients A repeated-measures crossover design will be used to test the home-based administration of STS tests The 30-second STS 30-s STS and 1-minute STS 1-min STS tests will be randomly administered across three test conditions centre-based remotely supervised and self-administered Data will summarize the feasibility of remotely supervised and self-administered STS tests and compare the performances of centre-based tests with remotely supervised and self-administered versions of STS tests in patients with CRD
Detailed Description:
This study aims to assess the implementation and measurement of both the 30s-STS and the 1-min STS tests when remotely supervised or self-administered in individuals with CRD More specifically the objectives of this study are as follows
i To explore the feasibility acceptability and implementation of remotely supervised and self-administered STS tests in individuals with CRD
ii To evaluate whether STS test performance differs by mode of administration 1 centre-based 2 remotely supervised and 3 self-administered in individuals with CRD
iii To investigate the clinical utility of remotely supervised and self-administered STS tests as a measure of functional status among in individuals with CRD
A repeated-measures crossover design will be used The 30-s STS and the 1-min STS tests will be administered to participants across three test conditions centre-based remotely supervised and self-administered
At the onset of the study participants will attend an initial orientation meeting over videoconference approximately 30 minutes to review the process of the study and data collection The orientation meeting will include instruction on completing the STS tests at home and participants will demonstrate a repetition of the STS Prior to completing the STS testing each participant will self-report their functional status using the modified version of the Pulmonary Functional Status and Dyspnea Questionnaire and demographicdescriptive measures will be collected from the participants clinical record Participants will complete the STS tests 30-second and 1-minute across three conditions centre-based remote self-administered The test order will be randomized by condition and will be completed on separate days For each testing condition the 30-s STS and 1-min STS tests will be completed in random order All tests will occur over a maximum 7-day period Neither the study staff nor the participants will be blinded to the order of their tests Blood oxygen level SpO2 heart rate HR and level of dyspnea Borg scale will be recorded before and immediately after each test On each test day participants will be given a 5-min rest period between each STS test protocol Before starting the second test participants will indicate that they feel ready to start and study staff will confirm participants oxygen level HR and dyspnea have returned to pre-test levels Delays in starting time past the 5-min rest period will be documented by research staff After completing three testing conditions participants will complete a questionnaire regarding feasibility and acceptability of different testing conditions
i To explore the feasibility acceptability and implementation of remotely supervised and self-administered STS tests in individuals with CRD
ii To evaluate whether STS test performance differs by mode of administration 1 centre-based 2 remotely supervised and 3 self-administered in individuals with CRD
iii To investigate the clinical utility of remotely supervised and self-administered STS tests as a measure of functional status among in individuals with CRD
A repeated-measures crossover design will be used The 30-s STS and the 1-min STS tests will be administered to participants across three test conditions centre-based remotely supervised and self-administered
At the onset of the study participants will attend an initial orientation meeting over videoconference approximately 30 minutes to review the process of the study and data collection The orientation meeting will include instruction on completing the STS tests at home and participants will demonstrate a repetition of the STS Prior to completing the STS testing each participant will self-report their functional status using the modified version of the Pulmonary Functional Status and Dyspnea Questionnaire and demographicdescriptive measures will be collected from the participants clinical record Participants will complete the STS tests 30-second and 1-minute across three conditions centre-based remote self-administered The test order will be randomized by condition and will be completed on separate days For each testing condition the 30-s STS and 1-min STS tests will be completed in random order All tests will occur over a maximum 7-day period Neither the study staff nor the participants will be blinded to the order of their tests Blood oxygen level SpO2 heart rate HR and level of dyspnea Borg scale will be recorded before and immediately after each test On each test day participants will be given a 5-min rest period between each STS test protocol Before starting the second test participants will indicate that they feel ready to start and study staff will confirm participants oxygen level HR and dyspnea have returned to pre-test levels Delays in starting time past the 5-min rest period will be documented by research staff After completing three testing conditions participants will complete a questionnaire regarding feasibility and acceptability of different testing conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None