DyspneaNCT01478932
Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
A study testing diaphragmatic breathing retraining and Health Promotion in people with Dyspnea, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to provide information on how the practicing of diaphragmatic breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage heart failure patients to engage in health-promoting activities by successfully controlling their shortness of breath (dyspnea). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- diaphragmatic breathing retraining and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2011to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults age 19 or older
- diagnosed with chronic heart failure
- experiencing shortness of breath at rest or with activities
- experiencing shortness of breath that limits their activity
- cognitively intact indicated by being able to describe what participation in the study will involve
- have a telephone; AND
- reside in a rural area either large rural (10,000-49,000 residents), small rural (2500- 9999 residents), or isolated (< 2499 residents) area
Who cannot join
- myocardial infarction or coronary bypass surgery within the last three months
- active chest pain
- uncontrolled arrhythmias (atrial fibrillation or ventricular tachycardia)
- on the transplant list or having a ventricular assist device
- orthopedic or neurological conditions that would impact muscle strength or interfere with the 6- minute walk test (6-MWT) (amputation, severe arthritis, Parkinson's, stroke, or severe neuropathy)
- history of severe chronic obstructive pulmonary disease (COPD); AND
- history of sleep breathing disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to provide information on how the practicing of diaphragmatic breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage heart failure patients to engage in health-promoting activities by successfully controlling their shortness of breath (dyspnea).
Read the detailed description
In heart failure (HF) patients, dyspnea is a key contributor to and the strongest predictor for hospital readmission. In addition, dyspnea and fatigue are the primary reasons for decreased physical activity (PA) which, in turn, leads to activity avoidance, subsequent muscle de-conditioning, and further increases of dyspnea even at lower levels of activity. Depression, because of its moderate relationship with dyspnea, can further diminish PA and increase disability in activities of daily living (ADLs). Strategies to minimize or mitigate dyspnea and to boost motivation are imperative for improving adherence to PA, and, in turn, improving fatigue, muscle strength, PA itself, functional status, disability in ADLs including basic ADLs and instrumental ADLs (IADLs), depression, and quality of life (QOL) in HF patients. The overall purpose of this pilot/feasibility study is to evaluate an 8-week, home-based DBR intervention, in HF patients who are experiencing dyspnea at rest or with daily activities. Using an experimental randomized controlled design, 50 participants over 19 years of age, with diagnosed with chronic HF, who experience dyspnea at rest or with activity and experience dyspnea that limits their activities, who have a telephone, and who reside in a rural area, will be recruited at the University of Nebraska Medical Center HF clinic and at the Veterans Affairs Nebraska-Western Iowa Hospital, Cardiology-Congestive Heart Failure clinic. Both groups will receive the usual care from a HF specialist. The experimental group will receive information on a Diaphragmatic Breathing Retraining (DBR) intervention whereas the health promotion (attention control) group will receive general health information. To boost adherence to the intervention and to prevent attrition from the study, both groups will receive telephone calls from a research nurse for a total of 4 sessions (weeks 1, 2, 4 and 6). During follow-ups via phone calls for the attention control group, the research personnel will discuss health promotion topics (e.g., lipids profile, health eating, cancer screening, and annual check-ups (e.g., flu shot, eye and/or dental exams) with their primary health care provider. Data collection using standardized measures, will take place at baseline, post-intervention, and 3-month follow-up after completion of the 8-week intervention. The primary outcomes are: dyspnea and fatigue. The secondary outcomes are: muscle strength, PA, functional status, depression, disability in ADLs, and quality of life.
- Conditions
- Dyspnea
- Being tested
- diaphragmatic breathing retraining, Health Promotion
- Keywords
- dyspnea, diaphragmatic breathing, Heart failure
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic breathing retrainingBehavioural
In-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept.
Health PromotionBehavioural
n-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth).
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing Retraining | Experimental | In-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept. Receives: Behavioral: diaphragmatic breathing retraining |
| Health Promotion | Placebo comparator | In-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth). Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Dyspnea rating scale of 0 to 4 (0 = none to 4 = extraordinary)
Measured: day 1, after 8-week intervention, after 5 months
Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS-57) Profile fatigue scale of 0 to 5 (0 = not at all to 5 = very much)
Measured: day 1, after 8-week intervention, after 5 months
Secondary outcomes (7)
Muscle Strength
Muscle strength will be measured by a Nicholas hand held dynamometer with the participant seated in a chair with feet on the floor. Measuring hip extensors will be done in a standing position. Muscle strength will be measured in kilograms (kg) of the maximum force exerted by the participant. The participants will be asked to "push as hard as you can against the dynamometer."
Measured: day 1, after 8-week intervention, after 5 months
Physical activity
Measured by placement of ActiHeart (Trade Mark) accelerometer monitor on participant in the morning and removal in the evening (times of placement and removal recorded in diary).
Measured: day 1, after 8-week intervention, after 5 months
Functional Status (6 minute walk test)
A 6-minute walking test is conducted on a 20 meter (22 yard) long course in an enclosed corridor. A chair will be placed at each end of the course to mark the turnaround point. Participants will be asked to walk the course at their own pace, covering as much distance as comfortable. Participants may slow down or stop and rest during the walk but will be asked to resume the exercise as soon as able.
Measured: day 1, after 8-week intervention, after 5 months
Functional Status (Timed Get Up & Go)
The participant will be asked to walk a distance of 3 meters along a line that will be timed at seconds from getting up from the chair, walking, and returning to sitting down in a chair.
Measured: day 1, after 8-week intervention, after 5 months
Depression Inventory
Participants complete Beck Depression Inventory questionnaire consisting of 21 groups of statements concerning depression and respond from 0 (do not agree) to 3 (strongly agree).
Measured: day 1, after 8-week intervention, after 5 months
Disability in Activities of Daily Life (ADL)
Participants complete Disabilities in ADL questionnaire of 7 activities of daily life and respond from 0 (need another person to do that on my behalf) to 3 (do it without assistance).
Measured: day 1, after 8-week intervention, after 5 months
Quality of Life questionnaire (self-care, usual activities, pain/discomfort, & Anxiety/Depression)
Participants complete EuroQol Group EuroQual_5DL questionnaire of 5 daily activities/conditions and respond from no problem, some problem, unable to perform/extreme condition.
Measured: day 1, after 8-week intervention, after 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study start9 Nov 2011
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Why it stopped: PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Yaewon Seo, PhD, Principal investigator, University of NebraskaBernice Yates, PhD, Study director, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478932
- Sponsor's protocol ID
- 0541-11-EP
- Other IDs
- 5P20NR011404-03
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2011
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
- ClinicalTrials.gov ID
- NCT01478932
- Acronym / sponsor ID
- 0541-11-EP
- Conditions
- Dyspnea
- Keywords
- dyspnea, diaphragmatic breathing, Heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left University
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Nov 2011 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide information on how the practicing of diaphragmatic breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage heart failure patients to engage in health-promoting activities by successfully controlling their shortness of breath (dyspnea).
Detailed description
In heart failure (HF) patients, dyspnea is a key contributor to and the strongest predictor for hospital readmission. In addition, dyspnea and fatigue are the primary reasons for decreased physical activity (PA) which, in turn, leads to activity avoidance, subsequent muscle de-conditioning, and further increases of dyspnea even at lower levels of activity. Depression, because of its moderate relationship with dyspnea, can further diminish PA and increase disability in activities of daily living (ADLs). Strategies to minimize or mitigate dyspnea and to boost motivation are imperative for improving adherence to PA, and, in turn, improving fatigue, muscle strength, PA itself, functional status, disability in ADLs including basic ADLs and instrumental ADLs (IADLs), depression, and quality of life (QOL) in HF patients. The overall purpose of this pilot/feasibility study is to evaluate an 8-week, home-based DBR intervention, in HF patients who are experiencing dyspnea at rest or with daily activities. Using an experimental randomized controlled design, 50 participants over 19 years of age, with diagnosed with chronic HF, who experience dyspnea at rest or with activity and experience dyspnea that limits their activities, who have a telephone, and who reside in a rural area, will be recruited at the University of Nebraska Medical Center HF clinic and at the Veterans Affairs Nebraska-Western Iowa Hospital, Cardiology-Congestive Heart Failure clinic. Both groups will receive the usual care from a HF specialist. The experimental group will receive information on a Diaphragmatic Breathing Retraining (DBR) intervention whereas the health promotion (attention control) group will receive general health information. To boost adherence to the intervention and to prevent attrition from the study, both groups will receive telephone calls from a research nurse for a total of 4 sessions (weeks 1, 2, 4 and 6). During follow-ups via phone calls for the attention control group, the research personnel will discuss health promotion topics (e.g., lipids profile, health eating, cancer screening, and annual check-ups (e.g., flu shot, eye and/or dental exams) with their primary health care provider. Data collection using standardized measures, will take place at baseline, post-intervention, and 3-month follow-up after completion of the 8-week intervention. The primary outcomes are: dyspnea and fatigue. The secondary outcomes are: muscle strength, PA, functional status, depression, disability in ADLs, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing Retraining | Experimental | Behavioral: diaphragmatic breathing retrainingIn-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept. |
| Health Promotion | Placebo comparator | Behavioral: Health PromotionIn-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults age 19 or older
- diagnosed with chronic heart failure
- experiencing shortness of breath at rest or with activities
- experiencing shortness of breath that limits their activity
- cognitively intact indicated by being able to describe what participation in the study will involve
Key exclusion criteria (7 listed)
- myocardial infarction or coronary bypass surgery within the last three months
- active chest pain
- uncontrolled arrhythmias (atrial fibrillation or ventricular tachycardia)
- on the transplant list or having a ventricular assist device
- orthopedic or neurological conditions that would impact muscle strength or interfere with the 6- minute walk test (6-MWT) (amputation, severe arthritis, Parkinson's, stroke, or severe neuropathy)
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 |
|---|---|---|
| diaphragmatic breathing retrainingIn-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept. | Behavioural | Diaphragmatic Breathing Retraining |
| Health Promotionn-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth). | Behavioural | Health Promotion |
Primary outcome
Dyspnea
Time frame: day 1, after 8-week intervention, after 5 months
Dyspnea rating scale of 0 to 4 (0 = none to 4 = extraordinary)
Fatigue
Time frame: day 1, after 8-week intervention, after 5 months
Patient Reported Outcomes Measurement Information System (PROMIS-57) Profile fatigue scale of 0 to 5 (0 = not at all to 5 = very much)
7 secondary outcomes
Muscle Strength
Time frame: day 1, after 8-week intervention, after 5 months
Physical activity
Time frame: day 1, after 8-week intervention, after 5 months
Functional Status (6 minute walk test)
Time frame: day 1, after 8-week intervention, after 5 months
Functional Status (Timed Get Up & Go)
Time frame: day 1, after 8-week intervention, after 5 months
Depression Inventory
Time frame: day 1, after 8-week intervention, after 5 months
Disability in Activities of Daily Life (ADL)
Time frame: day 1, after 8-week intervention, after 5 months
Quality of Life questionnaire (self-care, usual activities, pain/discomfort, & Anxiety/Depression)
Time frame: day 1, after 8-week intervention, after 5 months
Results and safety
The study was stopped early (reason given: PI left University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Yaewon Seo, PhD principal investigator
University of Nebraska
Bernice Yates, PhD study director
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic breathing retraining and Health Promotion in people with Dyspnea, run by University of Nebraska 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: PI left University). Results are not available in the source record.
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?
Dyspnea (time frame: day 1, after 8-week intervention, after 5 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 28 Nov 2023.