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

Primary Purpose

Dyspnea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diaphragmatic breathing retraining
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspnea focused on measuring dyspnea, diaphragmatic breathing, Heart failure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center, Herat Failure Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diaphragmatic Breathing Retraining

Arm Description

Outcomes

Primary Outcome Measures

dyspnea
dyspnea
dyspnea
Fatigue
Fatigue
Fatigue

Secondary Outcome Measures

muscle strength, physical activity, functional status, depression, disability in ADLs, and quality of life
muscle strength, physical activity, functional status, depression, disability, quality of life
muscle strength, physical activity, functional status, depression, disability

Full Information

First Posted
November 4, 2011
Last Updated
May 24, 2019
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01478932
Brief Title
Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
Official Title
Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
PI left University
Study Start Date
November 9, 2011 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
dyspnea, diaphragmatic breathing, Heart failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic Breathing Retraining
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
diaphragmatic breathing retraining
Intervention Description
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.
Primary Outcome Measure Information:
Title
dyspnea
Time Frame
day 1
Title
dyspnea
Time Frame
after 8-week intervention
Title
dyspnea
Time Frame
Total of 5 months
Title
Fatigue
Time Frame
day 1
Title
Fatigue
Time Frame
after 8-week intervention
Title
Fatigue
Time Frame
total of 5-months
Secondary Outcome Measure Information:
Title
muscle strength, physical activity, functional status, depression, disability in ADLs, and quality of life
Time Frame
day 1
Title
muscle strength, physical activity, functional status, depression, disability, quality of life
Time Frame
after 8-week intervention
Title
muscle strength, physical activity, functional status, depression, disability
Time Frame
total of 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaewon Seo, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernice Yates, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Study Director
Facility Information:
Facility Name
University of Nebraska Medical Center, Herat Failure Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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

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