Sit-to-Stand Tests for Lung Disease

(STS24 Trial)

Overseen By Lee Verweel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Disqualifiers: Recent surgery, Medically unstable, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dina Brooks, PhD

Principal Investigator

West Park Healthcare Centre

Eligibility Criteria

This trial is for individuals with chronic respiratory disease (CRD) who are interested in participating in a study to evaluate the effectiveness of sit-to-stand (STS) tests when done at home, either supervised remotely or self-administered.

Inclusion Criteria

Access to technology for remote supervision (e.g., mobile phone, laptop/computer, iPad)

I have a pulse oximeter at home to check my heart rate and oxygen levels.

I have been diagnosed with a chronic lung condition.

Exclusion Criteria

I have difficulty standing up from a seated position due to nerve or muscle issues.

I had surgery on my leg in the last 3 months.

Medically unstable to perform exercise tests (e.g., no exacerbation in the preceding two weeks)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Orientation

Participants attend an initial orientation meeting over videoconference to review the study process and data collection, including instruction on completing the STS tests at home.

30 minutes

1 visit (virtual)

Testing

Participants complete the 30-second and 1-minute STS tests across three conditions (centre-based, remote, self-administered) with random order over a 7-day period.

7 days

3 visits (mixed: in-person and virtual)

Follow-up

Participants complete a questionnaire regarding the feasibility and acceptability of different testing conditions.

1 day

Treatment Details

Interventions

• Sit-to-Stand Test (STS)

Trial Overview The study is testing how well STS tests work when done outside of a medical center. Participants will perform two types of STS tests: one lasting 30 seconds and another lasting one minute, under three conditions: at a center, supervised remotely, or on their own.

Participant Groups

Group I: Self-Administered Condition Experimental Treatment 1 Intervention

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.

Group II: Remotely Supervised Condition Experimental Treatment 1 Intervention

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.

Group III: Centre-Based Condition Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+