Comparing Centre-based, Remotely Supervised, and Self-administered Sit-to-stand Tests in Individuals With Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 30 second Sit-to-Stand Test
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sit-to-Stand Test (STS) (Other)
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.
干预措施: Sit-to-Stand Test (STS) (Other)
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.
干预措施: Sit-to-Stand Test (STS) (Other)
结局指标
主要结局
30 second Sit-to-Stand Test
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Dina Brooks
Senior Scientist, West Park Healthcare Centre
West Park Healthcare Centre