Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diaphragmatic Breathing Retraining 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. |
Behavioral: Diaphragmatic Breathing Retraining
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.
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Outcome Measures
Primary Outcome Measures
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [baseline]
Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [baseline]
Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [after an 8-week intervetion]
Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [3-month after an 8-week intervetion]
Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [after an 8-week intervetion]
Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.
- Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [3-month after an 8-week intervention]
Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.
Secondary Outcome Measures
- 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. [baseline]
Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).
- 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. [baseline]
Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).
- 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. [baseline]
Functional status will be measured by the 6-MWT and the Timed Get Up & Go.
- 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. [basline]
Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.
- 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. [baseline]
Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.
- 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. [basline]
Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).
- 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. [after an 8-week intervention]
Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).
- 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. [3-month after an 8-week intervention]
Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).
- 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. [after an 8-week intervetion]
Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).
- 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. [3-month after an 8-week intervention]
Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).
- 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. [after an 8-week intervention]
Functional status will be measured by the 6-MWT and the Timed Get Up & Go.
- 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. [3-month after an 8-week intervention]
Functional status will be measured by the 6-MWT and the Timed Get Up & Go.
- 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. [after an 8-week intervention]
Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.
- 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. [3-month after an 8-week intervention]
Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.
- 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. [after an 8-week intervention]
Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.
- 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. [3-month after an 8-week intervention]
Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.
- 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. [after an 8-week intervention]
Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).
- 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. [3-month after an 8-week intervention]
Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).
Eligibility Criteria
Criteria
Inclusion Criteria:
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adults age 19 or older who have Class III through IV heart failure as classified by the New York Heart Association (NYHA)
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cognitively intact indicated by being able to describe what participation in the study will involve
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have a consistent informal caregiver, who is willing to provide support to the participants, and a telephone
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residing in a rural area (population less than 2,500) (U.S. Census, 1995).
Exclusion Criteria:
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myocardial infarction or coronary bypass surgery within the last three months
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active chest pain
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uncontrolled arrhythmia (atrial fibrillation or ventricular tachycardia)
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on transplant list or has ventricular assist device
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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)
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history of severe COPD.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fremont Cardiovascular Specialists | Fremont | Nebraska | United States | 68025 |
| 2 | Veterans Affairs Nebraska-Western Iowa Hospital, Cardiology-Congestive Heart Failure clinic | Omaha | Nebraska | United States | 68105 |
| 3 | University of Nebraska Medical Center, Herat Failure clinic | Omaha | Nebraska | United States | 68198-7830 |
Sponsors and Collaborators
- University of Nebraska
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Yaewon Seo, PhD, RN, University of Nebraska
- Study Director: Bernice Yates, PhD, RN, University of Nebraska
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 179-09-FB
- 5P20NR011404-03