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

NCT06404008 | Completed

• 1 other identifier: STUDY00005553
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Stress; Dyspnea

Outcome Measures

Primary Outcomes (4)

• Intervention Feasibility

  IG: Completion of 2 in-person sessions (1 training, 1 trial) along with \>80% of daily individual practice of breathing protocol (15 minute twice daily)

  6 months

• Trial feasibility

  Rates of screening, enrollment, retention, reasons for exclusion and refusals, and attrition. Attrition goal \<10% throughout study period.

  6 months

• Acceptability (quantitative)

  Post-intervention survey on intervention acceptability with Likert scale rated 1 to 10; 10 being most acceptable. Overall average score ≥8 of 10 defined as acceptable. Will assess patient reported enjoyment, difficulty, and adherence

  6 months

• Acceptability (qualitative)

  Post-intervention semi-structured, in-depth interviews by telephone conducted by study coordinator to explore acceptability, barriers, facilitators, and survey burden

  6 months

Secondary Outcomes (3)

• Perceived Stress Scale

  Day 0, Day 8

• Modified Medical Research Council dyspnea scale

  Day 0, Day 8

• Mindful Attention Awareness Scale

  Day 0, Day 8

Other Outcomes (2)

• Lung Function

  Day 0, Day 8

• Heart rate variability

  Day 0, Day 8

Study Arms (2)

Behavioral Intervention (REST)

EXPERIMENTAL

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

Behavioral: REST

Control

ACTIVE COMPARATOR

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

Other: Education

Interventions

REST 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.

Behavioral Intervention (REST)

Education 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.

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Ascension Seton Medical Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the statistician will be blinded to study group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: July 15, 2024
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)