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

NCT ID: NCT06404008

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-07-02

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.

Conditions

COPD; Stress; Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention (REST)

Participants randomized to this group will receive COPD education, research staff support, and the REST (controlled breath) intervention.

Group Type: EXPERIMENTAL

REST

Intervention Type: BEHAVIORAL

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.

Control

Participants randomized to this group will receive COPD education and research staff support.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of spirometry confirmed COPD (FEV1/FVC <0.70 + FEV1<80%)
• Perceived Stress Scale > 13
• Age >40 years old
• Able to read, write, and speak in English
• Able to attend 1 in person training session and 1 in person trial sessions

Exclusion Criteria

• Current regular practice of breathing exercises or pranayama
• No access to internet or telephone
• Recent hospitalization for COPD exacerbation or any reason in the past 30 days
• Other primary lung disease (ILD, asthma, bronchiectasis) by self-report or chart review
• Non-correctable hearing impairment (i.e. hearing impairment despite hearing aids)
• Severe cognitive impairment

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Trisha M. Parekh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ascension Seton Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

STUDY00005553

Identifier Type: -

Identifier Source: org_study_id