Effects of a Rehabilitation Program on Immune Activation and Mood in Heart Failure Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Multi-Modality Rehabilitation Program on Immune Activation, Depressive Symptoms and Quality of Life in Heart Failure Patients. A Pilot Study

Conditions
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Heart Failure, Depressive Symptoms

Intervention / Treatment
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* Behavioral: multi-modality rehabilitation program for heart failure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: multi-modality rehabilitation program for heart failure|rehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory activity | levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical fitness | 6-min-walk test | 8 weeks | 
| Quality of Life | questionnaires: SF-36 (short-form-36), KCCQ (Kansas City Cardiomyopathy Questionnaire), EQoL-5D (European Quality of LIfe-5Dimensions) | 8 weeks | 
| Depressive Symptoms | questionnaire: HADS (Hospital Anxiety and Depression Scale) | 8 weeks |