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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Nebraska
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01478932
First received: November 4, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Dyspnea
Behavioral: diaphragmatic breathing retraining

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • dyspnea [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • dyspnea [ Time Frame: after 8-week intervention ] [ Designated as safety issue: No ]
  • dyspnea [ Time Frame: Total of 5 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: after 8-week intervention ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: total of 5-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle strength, physical activity, functional status, depression, disability in ADLs, and quality of life [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • muscle strength, physical activity, functional status, depression, disability, quality of life [ Time Frame: after 8-week intervention ] [ Designated as safety issue: No ]
  • muscle strength, physical activity, functional status, depression, disability [ Time Frame: total of 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 COPD; AND
  7. history of sleep breathing disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478932

Contacts
Contact: Yaewon Seo, PhD 402-559-6567 yaewonseo@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center, Herat Failure Clinic Recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Yaewon Seo, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Yaewon Seo, PhD University of Nebraska
Study Director: Bernice Yates, PhD University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01478932     History of Changes
Other Study ID Numbers: 541-11-EP, 5P20NR011404-03
Study First Received: November 4, 2011
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
dyspnea
diaphragmatic breathing
Heart failure

Additional relevant MeSH terms:
Dyspnea
Heart Failure
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 23, 2014