Chronic Lung DiseaseSTS24NCT06479252
Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD
A study testing Sit-to-Stand Test (STS) in people with Chronic Lung Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- Sit-to-Stand Test (STS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
West Park Healthcare Centre
Toronto, Ontario, M6M2J5
Dina Brooks, PhD, 905-525-9140 ext. 22110, brookd8@mcmaster.ca
Cindy Ellerton, MSc, 416-243-3600 ext. 32653, cindy.ellerton@westpark.org
About this study
Official title: Comparing Centre-based, Remotely Supervised, and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases
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.
Read the 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:
- 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
- Being tested
- Sit-to-Stand Test (STS)
- Keywords
- Assessment, Pulmonary Rehabilitation, Remote
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit-to-Stand Test (STS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Centre-Based Condition | Active comparator | 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. Receives: Other: Sit-to-Stand Test (STS) |
| Remotely Supervised Condition | Experimental | 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. Receives: Other: Sit-to-Stand Test (STS) |
| Self-Administered Condition | Experimental | 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. Receives: Other: Sit-to-Stand Test (STS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 second Sit-to-Stand Test
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. Scores on the STS tests will be recorded using the data collection form.
Measured: 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)
1 minute Sit-to-stand Test
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. Scores on the STS tests will be recorded using the data collection form.
Measured: 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 (3)
Oxygen Saturation (Sp02)
Oxygen saturation (Sp02) will be measured using a finger pulse oximeter before and after the 30-s and 1-min STS. Self-monitoring using remote pulse oximetry has been shown to be feasible and accurate in CRD populations. The oximeter will provide a printout of values reflecting oxygen level, which will be transcribed to a data collection form. Patients will be asked to use their own pulse oximeter, and the make and model will be recorded by study staff.
Measured: participants will be asked to record their oxygen saturation (Sp02) before and after the STS test (30 second and 1 minute) within each arm
Heart Rate
Heart rate will be measured using a finger pulse oximeter before and after the 30-s and 1-min STS tests. Self-monitoring using remote pulse oximetry has been shown to be feasible and accurate in chronic respiratory disease populations. The oximeter will provide a printout of values reflecting HR, which will be transcribed to a data collection form. Patients will be asked to use their own pulse oximeter, and the make and model will be recorded by study staff.
Measured: Participants will be asked to record their heart rate before and after the STS test (30 second and 1 minute) within each arm
Modified Borg Scale
The Modified Borg Dyspnea scale is a self-reported measure of one's difficulty breathing upon exertion. The instrument provides a standard method for patients to select ratings of dyspnea on a scale based on descriptors that correspond to specific numbers. At the start and at the end of each STS test, subjects will rate their perceived rate of dyspnea ("difficulty breathing") using the modified Borg Scale.
Measured: participants will be asked to record their data pre-and post STS test (30 second and 1 minute) within each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start22 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Brooks, West Park Healthcare Centre
- Investigators
- Dina Brooks, PhD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479252
- Sponsor's protocol ID
- WP-24-002
- Acronym
- STS24
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Centre-based, Remotely Supervised, and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT06479252
- Acronym / sponsor ID
- STS24 / WP-24-002
- Conditions
- Chronic Lung Disease
- Keywords
- Assessment, Pulmonary Rehabilitation, Remote
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Centre-Based Condition | Active comparator | Other: Sit-to-Stand Test (STS)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. |
| Remotely Supervised Condition | Experimental | Other: Sit-to-Stand Test (STS)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. |
| Self-Administered Condition | Experimental | Other: Sit-to-Stand Test (STS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Centre-Based Condition, Remotely Supervised Condition, Self-Administered Condition |
Primary outcome
30 second Sit-to-Stand Test
Time frame: 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)
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. Scores on the STS tests will be recorded using the data collection form.
1 minute Sit-to-stand Test
Time frame: 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)
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. Scores on the STS tests will be recorded using the data collection form.
3 secondary outcomes
Oxygen Saturation (Sp02)
Time frame: participants will be asked to record their oxygen saturation (Sp02) before and after the STS test (30 second and 1 minute) within each arm
Heart Rate
Time frame: Participants will be asked to record their heart rate before and after the STS test (30 second and 1 minute) within each arm
Modified Borg Scale
Time frame: participants will be asked to record their data pre-and post STS test (30 second and 1 minute) within each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Brooks, PhD principal investigator
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit-to-Stand Test (STS) in people with Chronic Lung Disease, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Verweel, MSc (647-281-9538, lee.verweel@westpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 second Sit-to-Stand Test (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.