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NCT05059132 · ClinicalTrials.gov registry record · NA
Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT05059132 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 31 participants.
The verdict
NCT05059132, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. The specific aims and hypotheses are: Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40). Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program. Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events. Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40). Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including: 1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
Interventions
- OTHER Education only
- BEHAVIORAL Tele-rehabilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059132
The ClinicalTrials.gov registry entry for NCT05059132 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Education only is the first listed.
NCT05059132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05059132 about?
NCT05059132 is a clinical study titled "Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study". This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. The specific aims and hypotheses are: Specific Aim 1: Conduct a pilot, phase IIb...
What is the current status of trial NCT05059132?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2022-01-10. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT05059132?
The interventions under investigation include: Education only (OTHER), Tele-rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT05059132?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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