Clinical trial NCT01478932: Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
Official title: Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Keywords: dyspnea
diaphragmatic breathing
Heart failure
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-11-23
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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 chronic obstructive pulmonary disease (COPD); AND
7. history of sleep breathing disorder

Primary outcomes:
measure: Dyspnea
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Fatigue
timeFrame: day 1, after 8-week intervention, after 5 months
Secondary outcomes:
measure: Muscle Strength
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Physical activity
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Functional Status (6 minute walk test)
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Functional Status (Timed Get Up & Go)
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Depression Inventory
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Disability in Activities of Daily Life (ADL)
timeFrame: day 1, after 8-week intervention, after 5 months
measure: Quality of Life questionnaire (self-care, usual activities, pain/discomfort, & Anxiety/Depression)
timeFrame: day 1, after 8-week intervention, after 5 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Yaewon Seo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Bernice Yates, PhD
role: STUDY_DIRECTOR
References: