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

Primary Purpose

Chronic Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
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 health services research trial for Chronic Heart Failure focused on measuring Heart Failure, Dyspnea, Diaphragmatic breathing retraining, Fatigue, Health-related Outcomes

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diaphragmatic Breathing Retraining

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Muscle strength is measured by Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN). Physical activity is measured by 7-items from Behavioral Risk Factor Surveillance System (BRFSS) (BRFSS, 2009; Kohl & Kimsey, 2009), ActiHeart (Respironics, Inc.), and ActiGraph (Model GT3X, Pensacola, FL). Functional status is measured by 6-MWT and Timed Get Up & Go. Disability in ADLs & IADLs is measured by restriction & modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, & toilet) & IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool. Depression is assessed by 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale. Quality of life is measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).

    Full Information

    First Posted
    June 17, 2013
    Last Updated
    August 9, 2023
    Sponsor
    University of Nebraska
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01886391
    Brief Title
    Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
    Official Title
    Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Major changes in study required new IRB application and approval
    Study Start Date
    November 2011 (Anticipated)
    Primary Completion Date
    May 15, 2012 (Actual)
    Study Completion Date
    May 15, 2012 (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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Heart Failure
    Keywords
    Heart Failure, Dyspnea, Diaphragmatic breathing retraining, Fatigue, Health-related Outcomes

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diaphragmatic Breathing Retraining
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Diaphragmatic Breathing Retraining
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.
    Description
    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.
    Time Frame
    baseline, after 8 week intervention and 3 months after 8 week intervention
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    Muscle strength is measured by Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN). Physical activity is measured by 7-items from Behavioral Risk Factor Surveillance System (BRFSS) (BRFSS, 2009; Kohl & Kimsey, 2009), ActiHeart (Respironics, Inc.), and ActiGraph (Model GT3X, Pensacola, FL). Functional status is measured by 6-MWT and Timed Get Up & Go. Disability in ADLs & IADLs is measured by restriction & modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, & toilet) & IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool. Depression is assessed by 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale. Quality of life is measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).
    Time Frame
    baseline, after 8 week intervention and 3 months after 8 week intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaewon Seo, PhD, RN
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bernice Yates, PhD, RN
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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