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

COPD Clinical Trial

— REST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404008
• Other study ID #: STUDY00005553
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: Kristina Kashyap, DO
• Phone: (512) 270-0614
• Email: kristina.kashyap[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of spirometry confirmed COPD (FEV1/FVC <0.70 + FEV1<80%)

• Perceived Stress Scale > 13

• COPD Assessment Test >10

• 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

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Stress

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Function	Forced expiratory volume in 1 second (L), Forced vital capacity, Inspiratory capacity	Day 0, Day 8
Other	Heart rate variability	Derived from 10-second ECG	Day 0, Day 8
Primary	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
Primary	Trial feasibility	Rates of screening, enrollment, retention, reasons for exclusion and refusals, and attrition. Attrition goal <10% throughout study period.	6 months
Primary	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
Primary	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	Perceived Stress Scale	10-item questionnaire with a score of 0-40, with higher scores indicating higher levels of stress.	Day 0, Day 8
Secondary	Modified Medical Research Council dyspnea scale	Self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4	Day 0, Day 8
Secondary	Mindful Attention Awareness Scale	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	Day 0, Day 8