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临床试验/NCT01886391
NCT01886391撤回不适用

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

University of Nebraska0 个研究点开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Effect of deep breathing to control shortness of breath and fatigue by slowing breathing to 6 breaths per minute.

时间窗: baseline, after 8 week intervention and 3 months after 8 week intervention

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.

次要结局

  • 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.(baseline, after 8 week intervention and 3 months after 8 week intervention)

研究者

申办方类型
Other
责任方
Sponsor

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