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

Not Applicable

Recruiting

• Conditions: Dyspnea; COPD; Stress
• Interventions: Behavioral: REST; Other: Education

• Registration Number: NCT06404008
• Lead Sponsor: University of Texas at Austin

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 Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-08
• Status Verified: 2024-07
• Study Start: 2024-07-15
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention (REST)	REST	Participants randomized to this group will receive COPD education, research staff support, and the REST (controlled breath) intervention.
Control	Education	Participants randomized to this group will receive COPD education and research staff support.

Primary Outcome Measures

Name	Time	Method
Acceptability (qualitative)	6 months	Post-intervention semi-structured, in-depth interviews by telephone conducted by study coordinator to explore acceptability, barriers, facilitators, and survey burden
Acceptability (quantitative)	6 months	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
Intervention Feasibility	6 months	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)
Trial feasibility	6 months	Rates of screening, enrollment, retention, reasons for exclusion and refusals, and attrition. Attrition goal \<10% throughout study period.

Secondary Outcome Measures

Name	Time	Method
Modified Medical Research Council dyspnea scale	Day 0, Day 8	Self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4
Mindful Attention Awareness Scale	Day 0, Day 8	The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
Perceived Stress Scale	Day 0, Day 8	10-item questionnaire with a score of 0-40, with higher scores indicating higher levels of stress.

Trial Locations

Locations (1)

Ascension Seton Medical Center; 🇺🇸 Austin, Texas, United States