Clinical trial NCT01886391: Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
Official title: Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Heart Failure
Dyspnea
Diaphragmatic breathing retraining
Fatigue
Health-related Outcomes
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.
timeFrame: baseline, after 8 week intervention and 3 months after 8 week intervention
Secondary outcomes:
measure: 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.
timeFrame: baseline, after 8 week intervention and 3 months after 8 week intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Yaewon Seo, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Bernice Yates, PhD, RN
role: STUDY_DIRECTOR
References: