Clinical trial NCT06404008: A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST)
Official title: A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST): A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Stress
Dyspnea
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 6 months
measure: Trial feasibility
timeFrame: 6 months
measure: Acceptability (quantitative)
timeFrame: 6 months
measure: Acceptability (qualitative)
timeFrame: 6 months
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Day 0, Day 8
measure: Modified Medical Research Council dyspnea scale
timeFrame: Day 0, Day 8
measure: Mindful Attention Awareness Scale
timeFrame: Day 0, Day 8
Other outcomes:
measure: Lung Function
timeFrame: Day 0, Day 8
measure: Heart rate variability
timeFrame: Day 0, Day 8
Locations:
city: Austin
country: United States
facility: Ascension Seton Medical Center
state: Texas
Study officials:
References: