Recruiting

STS Tests

Sponsor:

West Park Healthcare Centre

Code:

NCT06479252

Conditions

Chronic Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sit-to-Stand Test (STS)

Study Details

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.

Conditions

Chronic Lung Disease

Study ID

NCT06479252

Start date

Jun 22, 2024

Status verified date

Jul, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

experimental: 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.

Interventions

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.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Lee Verweel, MSc

647-281-9538lee.verweel@westpark.org

Lee Verweel

647-281-9538lee.verweel@westpark.org

Locations

West Park Healthcare Centre

Recruiting

Toronto, Ontario, Canada, M6M2J5

Contacts

Dina Brooks, PhD

905-525-9140brookd8@mcmaster.ca

Cindy Ellerton, MSc

416-243-3600cindy.ellerton@westpark.org

Principal Investigator:

Dina Brooks, PhD

More Information

Sponsor

West Park Healthcare Centre

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

  • Assessment
  • Pulmonary Rehabilitation
  • Remote

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Park Healthcare Centre on 2024-07-08.