Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404008
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-03
Brief Title:
A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients REST
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients REST A Randomized Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REST
Brief Summary:
This is a parallel design randomized controlled pilot trial comparing a controlled breath intervention REST to usual care for reducing stress in individuals with COPD
Detailed Description:
This is a parallel design randomized controlled pilot trial comparing a controlled breath intervention REST to usual care for reducing stress in individuals with chronic obstructive pulmonary disease COPD The intervention is based on the breathing techniques of Pranayama It was developed with patient and stakeholder input and is targeted for individuals with COPD who have moderate levels of stress and symptom burden The intervention is a 15-minute breathing protocol which will be taught to participants and subsequently evaluated in a clinic setting with surveys lung function and cardiac assessments This intervention will be pre-tested in 6 individuals revised and piloted in 30 individuals 15 in intervention group 15 in control group This study will answer the question of 1 whether a controlled breath protocol is feasible acceptable and safe for patients with COPD and 2 whether any modifications to the intervention are needed for a future multicenter trial to be proposed and conducted after the completion of the pilot trial We will also 3 obtain sufficient estimates of variability in stress measures to inform statistical planning of a future trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None