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

Sponsor

University of Nebraska (Other)

Overall Status

Terminated

CT.gov ID

NCT01478932

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arm

82.7

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

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

Actual Study Start Date :

Nov 9, 2011

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

dyspnea [day 1]
dyspnea [after 8-week intervention]
dyspnea [Total of 5 months]
Fatigue [day 1]
Fatigue [after 8-week intervention]
Fatigue [total of 5-months]

Secondary Outcome Measures

muscle strength, physical activity, functional status, depression, disability in ADLs, and quality of life [day 1]
muscle strength, physical activity, functional status, depression, disability, quality of life [after 8-week intervention]
muscle strength, physical activity, functional status, depression, disability [total of 5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adults age 19 or older
diagnosed with chronic heart failure
experiencing shortness of breath at rest or with activities
experiencing shortness of breath that limits their activity
cognitively intact indicated by being able to describe what participation in the study will involve
have a telephone; AND
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:

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