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

The University of Texas System (UT)

Status: Enrolling

Conditions: Dyspnea; COPD; Stress

Treatments: Other: Education; Behavioral: REST

Study type: Interventional

Funder types: Other

Identifiers

NCT06404008

STUDY00005553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Behavioral Intervention (REST)

Experimental group

Description:

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

Treatment:

Behavioral: REST

Control

Active Comparator group

Description:

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

Treatment:

Other: Education