Clinical trial NCT06479252: Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD
Official title: Comparing Centre-based, Remotely Supervised, and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Lung Disease
Keywords: Assessment
Pulmonary Rehabilitation
Remote
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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 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.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of chronic respiratory disease (e.g., Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Asthma).
* 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:

* Lower limb surgery in the preceding 3 months.
* 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.

Primary outcomes:
measure: 30 second Sit-to-Stand Test
timeFrame: Over a 7 day period, outcome will be collected at three time points (e.g., once within each testing condition: centre-based, remote, and self-administered)
measure: 1 minute Sit-to-stand Test
timeFrame: Over a 7 day period, outcome will be collected at three time points (e.g., once within each testing condition: centre-based, remote, and self-administered)
Secondary outcomes:
measure: Oxygen Saturation (Sp02)
timeFrame: participants will be asked to record their oxygen saturation (Sp02) before and after the STS test (30 second and 1 minute) within each arm
measure: Heart Rate
timeFrame: Participants will be asked to record their heart rate before and after the STS test (30 second and 1 minute) within each arm
measure: Modified Borg Scale
timeFrame: participants will be asked to record their data pre-and post STS test (30 second and 1 minute) within each arm
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References: