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临床试验/NCT01478932
NCT01478932终止不适用

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

University of Nebraska2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2011年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
2
主要终点
Fatigue

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
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
  • 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

排除标准

  • 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 chronic obstructive pulmonary disease (COPD); AND
  • history of sleep breathing disorder

结局指标

主要结局

Fatigue

时间窗: day 1, after 8-week intervention, after 5 months

Patient Reported Outcomes Measurement Information System (PROMIS-57) Profile fatigue scale of 0 to 5 (0 = not at all to 5 = very much)

Dyspnea

时间窗: day 1, after 8-week intervention, after 5 months

Dyspnea rating scale of 0 to 4 (0 = none to 4 = extraordinary)

次要结局

  • Quality of Life questionnaire (self-care, usual activities, pain/discomfort, & Anxiety/Depression)(day 1, after 8-week intervention, after 5 months)
  • Muscle Strength(day 1, after 8-week intervention, after 5 months)
  • Physical activity(day 1, after 8-week intervention, after 5 months)
  • Depression Inventory(day 1, after 8-week intervention, after 5 months)
  • Functional Status (6 minute walk test)(day 1, after 8-week intervention, after 5 months)
  • Functional Status (Timed Get Up & Go)(day 1, after 8-week intervention, after 5 months)
  • Disability in Activities of Daily Life (ADL)(day 1, after 8-week intervention, after 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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