Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD

NCT06479252 | Recruiting

• 1 other identifier: WP-24-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Assessment; Pulmonary Rehabilitation; Remote

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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

  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

  participants will be asked to record their data pre-and post STS test (30 second and 1 minute) within each arm

Study Arms (3)

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.

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.

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.

Other: Sit-to-Stand Test (STS)

Interventions

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.

Centre-Based Condition; Remotely Supervised Condition; Self-Administered Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M2J5, Canada

RECRUITING

Study Officials

• Dina Brooks, PhD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Verweel, MSc

CONTACT

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

Lee Verweel

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, West Park Healthcare Centre

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: June 22, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)