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Sit-to-Stand Tests for Lung Disease (STS24 Trial)

N/A

Recruiting

Led By Dina Brooks, PhD

Research Sponsored by West Park Healthcare Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to perform at least 5 repetitions in the 1-min sit-to-stand test without use of upper extremities

Physician diagnosis of chronic respiratory disease (e.g., Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Asthma)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be asked to record their oxygen saturation (sp02) before and after the sts test (30 second and 1 minute) within each arm

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test the use of sit-to-stand tests in chronic respiratory disease patients in home-based settings, either supervised remotely or self-administered. The study will compare the performance of these tests

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves physical activity through STS tests, potential side effects may include muscle soreness or fatigue. However, these exercises are generally considered safe for people with CRD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stand up and sit down at least 5 times in a minute without using my arms.

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I have been diagnosed with a chronic lung condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am at risk of falling when I try to stand up because of poor balance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be asked to record their oxygen saturation (sp02) before and after the sts test (30 second and 1 minute) within each arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be asked to record their oxygen saturation (sp02) before and after the sts test (30 second and 1 minute) within each arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be asked to record their oxygen saturation (sp02) before and after the sts test (30 second and 1 minute) within each arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1 minute Sit-to-stand Test

30 second Sit-to-Stand Test

Secondary study objectives

Heart Rate

Modified Borg Scale

Oxygen Saturation (Sp02)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Self-Administered ConditionExperimental Treatment1 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 ConditionExperimental Treatment1 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 ConditionActive Control1 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.

0 / 4Eligibility criteria met