Chronic Heart FailureNCT01886391
Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
A study testing Diaphragmatic Breathing Retraining in people with Chronic Heart Failure, run by University of Nebraska.
Trial summary
The purpose of this study is to provide information on how the practicing of deep breathing ("DBR" - diaphragmatic breathing re-training) may improve the health outcomes and likelihood of 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
- Chronic Heart Failure
- What is being tested?
- Diaphragmatic Breathing Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2011to 15 May 2012
- 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 who have Class III through IV heart failure as classified by the New York Heart Association (NYHA)
- cognitively intact indicated by being able to describe what participation in the study will involve
- have a consistent informal caregiver, who is willing to provide support to the participants, and a telephone
- residing in a rural area (population less than 2,500) (U.S. Census, 1995).
Who cannot join
- myocardial infarction or coronary bypass surgery within the last three months
- active chest pain
- uncontrolled arrhythmia (atrial fibrillation or ventricular tachycardia)
- on transplant list or has ventricular assist device
- skeletal or neurological conditions that would impact muscle strength or interfere with 6 minute walk test (6MWT) (amputation, severe arthritis, Parkinson's, stroke, or severe neuropathy)
- history of severe COPD.
About this study
The purpose of this study is to provide information on how the practicing of deep breathing ("DBR" - diaphragmatic breathing re-training) may improve the health outcomes and likelihood of 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 (shortness of breath), a key contributor to and the strongest predictor of a chief reason for hospital readmission with fatigue, are the primary reasons for modification in function leading to decreased physical activity (PA). Dyspnea and fatigue lead to activity avoidance, subsequent muscle de-conditioning, and further increases of dyspnea at even lower levels of activity. Depression, because of its moderate relationship both with perceived functional status and 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 weakness, PA itself, functional status, disability, and depression in HF patients. Thus, diaphragmatic breathing retraining (DBR) or deep breathing with a slow breathing pattern, a focus on decreasing dyspnea, and mediated by Self-efficacy for DBR and informal caregiver support during the DBR provide an innovative approach to positively impact the spiraling effects of HF. The purpose of this pilot/feasibility study is to evaluate a diaphragmatic breathing retraining (DBR) intervention that incorporates informal caregiver coaching to improve the primary outcomes of dyspnea, fatigue, and muscle weakness, and the secondary outcomes of PA, functional status, depression, disability, and depression.
- Conditions
- Chronic Heart Failure
- Being tested
- Diaphragmatic Breathing Retraining
- Keywords
- Heart Failure, Dyspnea, Diaphragmatic breathing retraining, Fatigue, Health-related Outcomes
- Medical subject headings
- Heart Failure, Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing RetrainingBehavioural
Diaphragmatic breathing retraining (DBR) with a slow breathing pattern such that breathe in slowly through the nose for 4 seconds and breathe out slowly through the mouth for 6 seconds and mediated by Self-efficacy for DBR. Patients in this group will receive detailed instructions, in-person, as to how to carry out the DBR intervention at home. They will provide a return demonstration to the research staff about how to do the deep breathing. They will also receive a written script of the DBR intervention. In addition to the script, patients in this group will receive 3 audio CDs (1 for week 1 [5-min DBR], 1 for week 2 [10-min DBR], 1 for weeks 3-8 [15-min DBR]), developed by the PI, to use to practice their deep breathing.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing Retraining | Experimental | Diaphragmatic breathing retraining (DBR) with a slow breathing pattern such that breathe in slowly through the nose for 4 seconds and breathe out slowly through the mouth for 6 seconds and mediated by Self-efficacy for DBR. Patients in this group will receive detailed instructions, in-person, as to how to carry out the DBR intervention at home. They will provide a return demonstration to the research staff about how to do the deep breathing. They will also receive a written script of the DBR intervention. In addition to the script, patients in this group will receive 3 audio CDs (1 for week 1 [5-min DBR], 1 for week 2 [10-min DBR], 1 for weeks 3-8 [15-min DBR]), developed by the PI, to use to practice their deep breathing. Receives: Behavioral: Diaphragmatic Breathing Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.
Dyspnea is measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and by 18 items of dyspnea from activities composed of basic activities of daily living (ADLs), instrumental activities of daily living (IADLs), and other activities related to physical functioning using a 10-point Liker scale. Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.
Measured: baseline, after 8 week intervention and 3 months after 8 week intervention
Secondary outcomes (1)
Effect of deep breathing on the secondary outcomes of muscle strength, physical activity, functional status, disability in activities of daily living, and instrumental activities daily living, depression, and quality of life.
Muscle strength is measured by Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN). Physical activity is measured by 7-items from Behavioral Risk Factor Surveillance System (BRFSS) (BRFSS, 2009; Kohl \& Kimsey, 2009), ActiHeart (Respironics, Inc.), and ActiGraph (Model GT3X, Pensacola, FL). Functional status is measured by 6-MWT and Timed Get Up \& Go. Disability in ADLs \& IADLs is measured by restriction \& modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, \& toilet) \& IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool. Depression is assessed by 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale. Quality of life is measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).
Measured: baseline, after 8 week intervention and 3 months after 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start1 Nov 2011
- Primary completion15 May 2012
- Study completion15 May 2012
Why it stopped: Major changes in study required new IRB application and approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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, RN, Principal investigator, University of NebraskaBernice Yates, PhD, RN, Study director, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886391
- Sponsor's protocol ID
- 0179-09-FB
- Other IDs
- 5P20NR011404-03
- Status last verified
- Oct 2024
- First submitted
- 17 Jun 2013
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01886391
- Acronym / sponsor ID
- 0179-09-FB
- Conditions
- Chronic Heart Failure
- Keywords
- Heart Failure, Dyspnea, Diaphragmatic breathing retraining, Fatigue, Health-related Outcomes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Major changes in study required new IRB application and approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 15 May 2012 (actual)
- Study completion
- 15 May 2012 (actual)
- First posted
- 25 Jun 2013 (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 deep breathing ("DBR" - diaphragmatic breathing re-training) may improve the health outcomes and likelihood of 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 (shortness of breath), a key contributor to and the strongest predictor of a chief reason for hospital readmission with fatigue, are the primary reasons for modification in function leading to decreased physical activity (PA). Dyspnea and fatigue lead to activity avoidance, subsequent muscle de-conditioning, and further increases of dyspnea at even lower levels of activity. Depression, because of its moderate relationship both with perceived functional status and 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 weakness, PA itself, functional status, disability, and depression in HF patients. Thus, diaphragmatic breathing retraining (DBR) or deep breathing with a slow breathing pattern, a focus on decreasing dyspnea, and mediated by Self-efficacy for DBR and informal caregiver support during the DBR provide an innovative approach to positively impact the spiraling effects of HF. The purpose of this pilot/feasibility study is to evaluate a diaphragmatic breathing retraining (DBR) intervention that incorporates informal caregiver coaching to improve the primary outcomes of dyspnea, fatigue, and muscle weakness, and the secondary outcomes of PA, functional status, depression, disability, and depression.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing Retraining | Experimental | Behavioral: Diaphragmatic Breathing RetrainingDiaphragmatic breathing retraining (DBR) with a slow breathing pattern such that breathe in slowly through the nose for 4 seconds and breathe out slowly through the mouth for 6 seconds and mediated by Self-efficacy for DBR. Patients in this group will receive detailed instructions, in-person, as to how to carry out the DBR intervention at home. They will provide a return demonstration to the research staff about how to do the deep breathing. They will also receive a written script of the DBR intervention. In addition to the script, patients in this group will receive 3 audio CDs (1 for week 1 [5-min DBR], 1 for week 2 [10-min DBR], 1 for weeks 3-8 [15-min DBR]), developed by the PI, to use to practice their deep breathing. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults age 19 or older who have Class III through IV heart failure as classified by the New York Heart Association (NYHA)
- cognitively intact indicated by being able to describe what participation in the study will involve
- have a consistent informal caregiver, who is willing to provide support to the participants, and a telephone
- residing in a rural area (population less than 2,500) (U.S. Census, 1995).
Key exclusion criteria (6 listed)
- myocardial infarction or coronary bypass surgery within the last three months
- active chest pain
- uncontrolled arrhythmia (atrial fibrillation or ventricular tachycardia)
- on transplant list or has ventricular assist device
- skeletal or neurological conditions that would impact muscle strength or interfere with 6 minute walk test (6MWT) (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 RetrainingDiaphragmatic breathing retraining (DBR) with a slow breathing pattern such that breathe in slowly through the nose for 4 seconds and breathe out slowly through the mouth for 6 seconds and mediated by Self-efficacy for DBR. Patients in this group will receive detailed instructions, in-person, as to how to carry out the DBR intervention at home. They will provide a return demonstration to the research staff about how to do the deep breathing. They will also receive a written script of the DBR intervention. In addition to the script, patients in this group will receive 3 audio CDs (1 for week 1 [5-min DBR], 1 for week 2 [10-min DBR], 1 for weeks 3-8 [15-min DBR]), developed by the PI, to use to practice their deep breathing. | Behavioural | Diaphragmatic Breathing Retraining |
Primary outcome
Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.
Time frame: baseline, after 8 week intervention and 3 months after 8 week intervention
Dyspnea is measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and by 18 items of dyspnea from activities composed of basic activities of daily living (ADLs), instrumental activities of daily living (IADLs), and other activities related to physical functioning using a 10-point Liker scale. Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.
1 secondary outcome
Effect of deep breathing on the secondary outcomes of muscle strength, physical activity, functional status, disability in activities of daily living, and instrumental activities daily living, depression, and quality of life.
Time frame: baseline, after 8 week intervention and 3 months after 8 week intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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, RN principal investigator
University of Nebraska
Bernice Yates, PhD, RN study director
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing Retraining in people with Chronic Heart Failure, run by University of Nebraska.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. (time frame: baseline, after 8 week intervention and 3 months after 8 week intervention). 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 17 Oct 2024.