NCT06404008

A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST)

A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST): A Randomized Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Stress
• Dyspnea

Interventions

Type	Name	Description
BEHAVIORAL	REST	After randomization, individuals will attend an in-person training session in the REST protocol. This is a 15 minute controlled breath protocol that includes 3 yoga breathing techniques: 3-part dirgha breath, alternate nostril breathing, and 2:1 breathing. Each technique will be completed for 5 minutes, for a total of 15 minutes. After the training session, participants will practice the REST protocol for 15 minutes twice a day with guidance from research staff over zoom (Days 1-7) with daily COPD education including inhaler technique, nutrition, vaccinations, tobacco cessation counseling, and exacerbation education. On Day 8, participants will attend the Trial Session where they will complete the REST protocol (15 minutes) while vitals, lung function, and ECG measurements are taken. Surveys will be administered before and after the REST protocol to document patient reported stress and dyspnea.
OTHER	Education	After randomization, individuals will attend an in-person education session led by a research coordinator. For the following 7 days, the research staff will call patients daily and provide daily COPD education including inhaler technique, nutrition, vaccinations, tobacco cessation counseling, and COPD exacerbation education. On Day 8, participants will attend the Trial Session where they will do spontaneous breathing (15 minutes) while vitals, lung function, and EKG measurements are taken. Surveys will be administered before and after the spontaneous breathing period to document patient reported stress and dyspnea. After the study, participants will be asked to complete a close out survey and interview over zoom.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2024-05-08
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States