Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478932
Recruitment Status : Unknown
Verified January 2014 by University of Nebraska.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : January 8, 2014
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Nebraska

Brief 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).

Condition or disease Intervention/treatment Phase
Dyspnea Behavioral: diaphragmatic breathing retraining Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
Study Start Date : December 2011
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Diaphragmatic Breathing Retraining Behavioral: diaphragmatic breathing retraining
Experimental group participates in an 8-week breathing retraining intervention that requires 30 minutes a day. Control group receives an 8-week health promotion attention control condition.

Primary Outcome Measures :
  1. dyspnea [ Time Frame: day 1 ]
  2. dyspnea [ Time Frame: after 8-week intervention ]
  3. dyspnea [ Time Frame: Total of 5 months ]
  4. Fatigue [ Time Frame: day 1 ]
  5. Fatigue [ Time Frame: after 8-week intervention ]
  6. Fatigue [ Time Frame: total of 5-months ]

Secondary Outcome Measures :
  1. muscle strength, physical activity, functional status, depression, disability in ADLs, and quality of life [ Time Frame: day 1 ]
  2. muscle strength, physical activity, functional status, depression, disability, quality of life [ Time Frame: after 8-week intervention ]
  3. muscle strength, physical activity, functional status, depression, disability [ Time Frame: total of 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. adults age 19 or older
  2. diagnosed with chronic heart failure
  3. experiencing shortness of breath at rest or with activities
  4. experiencing shortness of breath that limits their activity
  5. cognitively intact indicated by being able to describe what participation in the study will involve
  6. have a telephone; AND
  7. reside in a rural area either large rural (10,000-49,000 residents), small rural (2500- 9999 residents), or isolated (< 2499 residents) area

Exclusion Criteria:

  1. myocardial infarction or coronary bypass surgery within the last three months
  2. active chest pain
  3. uncontrolled arrhythmias (atrial fibrillation or ventricular tachycardia)
  4. on the transplant list or having a ventricular assist device
  5. 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)
  6. history of severe COPD; AND
  7. history of sleep breathing disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478932

Contact: Yaewon Seo, PhD 402-559-6567

United States, Nebraska
University of Nebraska Medical Center, Herat Failure Clinic Recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Yaewon Seo, PhD         
Sponsors and Collaborators
University of Nebraska
National Institute of Nursing Research (NINR)
Principal Investigator: Yaewon Seo, PhD University of Nebraska
Study Director: Bernice Yates, PhD University of Nebraska

Responsible Party: University of Nebraska Identifier: NCT01478932     History of Changes
Other Study ID Numbers: 541-11-EP
5P20NR011404-03 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Keywords provided by University of Nebraska:
diaphragmatic breathing
Heart failure

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms