Effects of a Multi-Modality Rehabilitation Program on Immune Activation, Depressive Symptoms and Quality of Life in Heart Failure Patients. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- inflammatory activity
研究概览
简要总结
The aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise training as a main pillar, and to further investigate if there are correlations between changes in immune regulation, depressive symptoms and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of heart failure with reduced ejection fraction (HFREF) with an EF ≤ 45%, NYHA (New York Heart Association) I - III; ACC/AHA (American College of Cariology/ American Heart Association) stage C, irrespective of etiology
- •Clinically stable patients without deterioration or hospitalization due to heart failure within the last 4 weeks
- •Neuro-hormonal medication according to the ESC (European Society of Cardiology) guidelines for the treatment of chronic heart failure consisting of antagonists of the Renin-Angiotensin-Aldosterone System (RAAS) and beta-blockers as indicated.
- •Ability to fully understand all elements of and sign the written informed consent before initiation of the study
排除标准
- •Fluid retention of cardiac decompensation, necessitating i.v. diuretic therapy
- •Myocardial infarction within the last 2 months
- •Surgery including cardiovascular or valvular surgery within 3 Months
- •Uncontrolled proinflammatory comorbidities (e.g. Diabetes mellitus HbA1c >9%, COPD ( chronic obstructive pulmonary disease) >II, active rheumatic diseases and autoimmune disorders)
- •Current infectious diseases ( e.g. pneumonia, COPD exacerbations or urinary tract infections)
- •Morbid obesity: BMI > 40
- •Alcohol or drug abuse
- •psychiatric disorders
结局指标
主要结局
inflammatory activity
时间窗: 8 weeks
levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1
次要结局
- Quality of Life(8 weeks)
- physical fitness(8 weeks)
- Depressive Symptoms(8 weeks)
研究者
Dr. Katherine Wachmann
Study coordinator
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation