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

NCT01886391 | Withdrawn DMC

• 2 other identifiers: 0179-09-FB5P20NR011404-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Heart Failure

Keywords

Heart Failure; Dyspnea; Diaphragmatic breathing retraining; Fatigue; Health-related Outcomes

Outcome Measures

Primary Outcomes (1)

• Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.

  Dyspnea is measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and by 18 items of dyspnea from activities composed of basic activities of daily living (ADLs), instrumental activities of daily living (IADLs), and other activities related to physical functioning using a 10-point Liker scale. Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.

  baseline, after 8 week intervention and 3 months after 8 week intervention

Secondary Outcomes (1)

• 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.

  baseline, after 8 week intervention and 3 months after 8 week intervention

Study Arms (1)

Diaphragmatic Breathing Retraining

EXPERIMENTAL

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.

Behavioral: Diaphragmatic Breathing Retraining

Interventions

Diaphragmatic Breathing Retraining 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.

Diaphragmatic Breathing Retraining

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Nursing Research (NINR): collaborator

MeSH Terms

Conditions

Heart Failure; Dyspnea; Fatigue

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yaewon Seo, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Bernice Yates, PhD, RN

  University of Nebraska

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 25, 2013
• Study Start: November 1, 2011
• Primary Completion: May 15, 2012
• Study Completion: May 15, 2012
• Last Updated: October 17, 2024

Record last verified: 2024-10