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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindful Breathing

Home-Based Pulmonary Rehabilitation

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be ≥40 years old
Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score
Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking

Exclusion Criteria:

Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state; or are not living in the healthcare area
Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition)
Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).

Sites / Locations

Mayo Clinic RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module

Home-based pulmonary rehabilitation that includes health coaching

Outcomes

Primary Outcome Measures

Breathlessness

Breathlessness as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including dyspnea (breathlessness). Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.

Emotion

Emotion as measured by the Chronic Respiratory Disease Questionnaire. The Chronic Respiratory Disease Questionnaire is a 20-question inventory assessing four areas, including emotion. Patients rate their experience numerically on a 7-point modified Likert scale of 1 to7 with higher ratings indicating less symptom impairment. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.

Secondary Outcome Measures

Physical Activity

Physical activity as measured by the ActiGraph, primarily daily steps

Full Information

NCT ID

NCT05349123

First Posted

April 22, 2022

Last Updated

July 6, 2023

Sponsor

Minnesota HealthSolutions

Collaborators

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05349123

Brief Title

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Official Title

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Minnesota HealthSolutions

Collaborators

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The Mindful Breathing Laboratory under the direction of Dr. Benzo will complete a randomized controlled trial to evaluate the mindful breathing module. This rigorous study will evaluate home-based PR system compared to the home-based PR system plus mindful breathing module for its effects on breathlessness and emotions. The investigators hypothesize that the intervention will decrease breathlessness while increasing emotional perception, emotional intelligence, and mindfulness.

Detailed Description

A total of 50 adults diagnosed with COPD will be enrolled in this study. Half of the subjects will be randomized to receive home-based pulmonary rehabilitation with the mindful breathing module (intervention group) and half will receive home-based pulmonary rehabilitation (control group). Each subject will be consented and trained and then participate in either the intervention or control group. Both groups entail one week of baseline and twelve weeks of home-based pulmonary rehabilitation (health coaching plus activity monitoring). The intervention group will also receive the mindful breathing module during the twelve weeks of home-based pulmonary rehabilitation. The Chronic Respiratory Disease Questionnaire (CRQ) will be administered at baseline, week 12 (after the intervention) and week 24 as the investigators will follow the patients for 3 months after the intervention to document the sustainability of the effects (behavior change).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Half of the subjects will be randomized to receive home-based PR with the mindful breathing module (intervention group) and half will receive home-based PR (control group).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Home-based pulmonary rehabilitation that includes health coaching

Intervention Type

Behavioral

Intervention Name(s)

Mindful Breathing

Intervention Description

Subject will be expected to do 12 weeks of home-based rehabilitation, 6 days a week in their home. The proposed project explores the addition of a mindful breathing module, which involves daily guided breathing practice with feedback to encourage mindful breathing.

Intervention Type

Behavioral

Intervention Name(s)

Home-Based Pulmonary Rehabilitation

Other Intervention Name(s)

Health Coaching

Intervention Description

Subject will be asked to complete exercise guided by a video six days a week and to complete mindful walking six days per week. They will receive weekly health coaching calls.

Primary Outcome Measure Information:

Title

Breathlessness

Description

Time Frame

12 weeks

Title

Emotion

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Physical Activity

Description

Physical activity as measured by the ActiGraph, primarily daily steps

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be ≥40 years old Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking Exclusion Criteria: Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state; or are not living in the healthcare area Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition) Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of <20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sara J Seifert, MPH

Phone

16128036998

sara@minnhealth.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin Kramer, PhD

Phone

612-386-6644

kevin@minnhealth.com

Facility Information:

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Benzo, MD

Phone

507-284-0561

benzo.roberto@mayo.edu

First Name & Middle Initial & Last Name & Degree

Johanna Hoult

Phone

507-284-0561

Hoult.Johanna@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

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