Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD
NCT ID: NCT06479252
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-22
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Centre-Based Condition
Participants will be asked travel to West Park Healthcare Centre to complete the sit-to-stand (STS) tests under the supervision of a trained research team member. Participants will be guided through the standardized protocol for the STS tests.
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.
Remotely Supervised Condition
The sit-to-stand (STS) tests will be conducted in the patient's home and will be remotely monitored by a research staff member situated at the healthcare centre (via videoconference). The research team member will send a meeting invite to the participant who will independently join the videoconference from their home. At the onset of the study, participants will receive a handout to explain the materials they need to prepare for the session. Guidance will also be provided during the orientation meeting. Based on chair availability in participant's home, deviations will be noted by study staff. The testing procedure and instructions will be the same as the centre-based testing described.
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.
Self-Administered Condition
The self-administered sit-to-stand (STS) tests will be conducted independently by the patient in their home setting. No supervision will be provided by study staff during the testing sessions. At the onset of the study, participants will receive a handout to explain the materials they need to prepare for the session. Detailed instructions for completing the STS tests independently will be provided to the participant (Appendix B). Guidance will also be provided during the orientation meeting. The instructions and guide to self-administer the test will be piloted at the start of the study, and the content may be refined to meet the needs of patients.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Male and female patients ≥18 years of age.
* Able to perform at least 5 repetitions in the 1-min sit-to-stand test without use of upper extremities.
* Access to a portable pulse oximeter at home to measure heart rate and oxygen saturation.
* Access to technology for remote supervision (e.g., mobile phone, laptop/computer, iPad)
Exclusion Criteria
* Medically unstable to perform exercise tests (e.g., no exacerbation in the preceding two weeks).
* Predominant neurological or musculoskeletal limitations to completing sit-to-stand.
* At risk of falling during sit-to-stand due to impaired balance, as indicated in their clinical record, and/or PR assessment.
18 Years
ALL
No
Sponsors
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West Park Healthcare Centre
OTHER
Responsible Party
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Dina Brooks
Senior Scientist, West Park Healthcare Centre
Principal Investigators
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Dina Brooks, PhD
Role: PRINCIPAL_INVESTIGATOR
West Park Healthcare Centre
Locations
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West Park Healthcare Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WP-24-002
Identifier Type: -
Identifier Source: org_study_id
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