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This study has been withdrawn prior to enrollment.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

June 17, 2013
January 7, 2014
November 2011
June 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01886391 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients
Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients

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).

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Chronic Heart Failure
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.
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.
Intervention: Behavioral: Diaphragmatic Breathing Retraining
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01886391
179-09-FB, 5P20NR011404-03
Yes
Yaewon Seo, University of Nebraska
University of Nebraska
National Institute of Nursing Research (NINR)
Principal Investigator: Yaewon Seo, PhD, RN University of Nebraska
Study Director: Bernice Yates, PhD, RN University of Nebraska
University of Nebraska
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP