NCT06479252

Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD

Comparing Centre-based, Remotely Supervised, and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: West Park Healthcare Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 demographic/descriptive measures will be collected from the participant's 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.

Conditions

• Chronic Lung Disease

Interventions

Type	Name	Description
OTHER	Sit-to-Stand Test (STS)	The 30-s and 1-min STS tests are reliable, valid, and responsive tests for measuring functional exercise capacity in patients with lung disease. For the STS tests that are centre-based or supervised remotely, investigators will collect the total number of repetitions on the 30-s and 1-min STS tests, as well as the number and duration of rests within and between tests.

Timeline

• Start date: 2024-06-22
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-06-28
• Last updated: 2024-07-08

Locations

1 site across 1 country: Canada