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

NCT ID: NCT01886391

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-01
• Study Completion Date: 2012-05-15

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diaphragmatic Breathing Retraining

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaewon Seo, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Bernice Yates, PhD, RN

Role: STUDY_DIRECTOR

University of Nebraska

Other Identifiers

5P20NR011404-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0179-09-FB

Identifier Type: -

Identifier Source: org_study_id