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

This study has been withdrawn prior to enrollment.
(Major changes in study required new IRB application and approval)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yaewon Seo, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01886391
First received: June 17, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Chronic Heart Failure
Behavioral: Diaphragmatic Breathing Retraining

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.

  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.

  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: after an 8-week intervetion ] [ Designated as safety issue: No ]
    Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.

  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: 3-month after an 8-week intervetion ] [ Designated as safety issue: No ]
    Fatigue will be measured by 8-items from the PROMIS-57 Profile v.10.

  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: after an 8-week intervetion ] [ Designated as safety issue: No ]
    Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.

  • Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Dyspnea will be measured by three items from the domains of symptom prevalence and symptom burden of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and will also be measured by 18 items of dyspnea with 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.


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. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).

  • 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. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).

  • 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. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Functional status will be measured by the 6-MWT and the Timed Get Up & Go.

  • 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. [ Time Frame: basline ] [ Designated as safety issue: No ]
    Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.

  • 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. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.

  • 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. [ Time Frame: basline ] [ Designated as safety issue: No ]
    Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).

  • 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. [ Time Frame: after an 8-week intervention ] [ Designated as safety issue: No ]
    Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Muscle strength will be measured by the Nicholas dynamometer (Model 01160, Lafayette Instrument Co., Lafayette, IN).

  • 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. [ Time Frame: after an 8-week intervetion ] [ Designated as safety issue: No ]
    Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Physical activity will be measured by three measures: 1) 7-items from the Behavioral Risk Factor Surveillance System (BRFSS) (Behavioral Risk Factor Surveillance System [BRFSS], 2009; Kohl & Kimsey, 2009), 2) the ActiHeart (Respironics, Inc.), and 3) the ActiGraph (Model GT3X, Pensacola, FL).

  • 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. [ Time Frame: after an 8-week intervention ] [ Designated as safety issue: No ]
    Functional status will be measured by the 6-MWT and the Timed Get Up & Go.

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Functional status will be measured by the 6-MWT and the Timed Get Up & Go.

  • 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. [ Time Frame: after an 8-week intervention ] [ Designated as safety issue: No ]
    Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Disability in ADLs and IADLs will be measured by restriction and modification in performance of 13 activities composed of basic ADLs (bathing, dressing, feeding, transfer, continence, and toilet) and IADLs (shopping, transportation, telephone, preparing meals, housework, taking medication, and handling money) taken from the Older American Resource Services (OARS) tool.

  • 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. [ Time Frame: after an 8-week intervention ] [ Designated as safety issue: No ]
    Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Depression will be assessed by the 21-item Beck Depression Inventory II (Beck et al., 1996) using a 4-point Likert scale.

  • 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. [ Time Frame: after an 8-week intervention ] [ Designated as safety issue: No ]
    Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).

  • 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. [ Time Frame: 3-month after an 8-week intervention ] [ Designated as safety issue: No ]
    Quality of life will be measured by the EuroQol 5-D (EQ-5D; The EuroQol Group, 1990).


Enrollment: 0
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01886391

Locations
United States, Nebraska
Fremont Cardiovascular Specialists
Fremont, Nebraska, United States, 68025
University of Nebraska Medical Center, Herat Failure clinic
Omaha, Nebraska, United States, 68198-7830
Veterans Affairs Nebraska-Western Iowa Hospital, Cardiology-Congestive Heart Failure clinic
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Yaewon Seo, PhD, RN University of Nebraska
Study Director: Bernice Yates, PhD, RN University of Nebraska
  More Information

No publications provided

Responsible Party: Yaewon Seo, Prinicipal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01886391     History of Changes
Other Study ID Numbers: 179-09-FB, 5P20NR011404-03
Study First Received: June 17, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Nebraska:
Heart Failure
Dyspnea
Diaphragmatic breathing retraining
Fatigue
Health-related Outcomes

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014