Chronic Obstructive Pulmonary DiseaseNCT05349123
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
A study testing Mindful Breathing and Home-Based Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Minnesota HealthSolutions at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Mindful Breathing and Home-Based Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 7 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Mindful Breathing, Home-Based Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful BreathingBehavioural
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.
Home-Based Pulmonary RehabilitationBehavioural
Also called Health Coaching
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Home-based pulmonary rehabilitation that includes health coaching with mindful breathing module Receives: Behavioral: Mindful Breathing; Behavioral: Home-Based Pulmonary Rehabilitation |
| Control | Active comparator | Home-based pulmonary rehabilitation that includes health coaching Receives: Behavioral: Home-Based Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months, 6 months
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.
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
Physical Activity
Physical activity as measured by the ActiGraph, primarily daily steps
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start10 Jan 2022
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota HealthSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349123
- Sponsor's protocol ID
- Mindful Breathing Awareness
- Status last verified
- May 2025
- First submitted
- 22 Apr 2022
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
- ClinicalTrials.gov ID
- NCT05349123
- Acronym / sponsor ID
- Mindful Breathing Awareness
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Minnesota HealthSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful Breathing, Behavioral: Home-Based Pulmonary RehabilitationHome-based pulmonary rehabilitation that includes health coaching with mindful breathing module |
| Control | Active comparator | Behavioral: Home-Based Pulmonary RehabilitationHome-based pulmonary rehabilitation that includes health coaching |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful BreathingSubject 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. | Behavioural | Intervention |
| Home-Based Pulmonary RehabilitationAlso: Health CoachingSubject 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. | Behavioural | Control, Intervention |
Primary outcome
Breathlessness
Time frame: baseline, 3 months, 6 months
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
Time frame: baseline, 3 months, 6 months
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.
1 secondary outcome
Physical Activity
Time frame: baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Breathing and Home-Based Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Minnesota HealthSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.