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

Completed

• Conditions: Depressive Symptoms; Heart Failure

• Registration Number: NCT02358525
• Lead Sponsor: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-19
• Study Start: 2015-01
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inflammatory activity	8 weeks	levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1

Secondary Outcome Measures

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

Trial Locations

Locations (2)

SALK, 2.Medizin, HI-Ambulanz; 🇦🇹 Salzburg, Austria

Ska Rz Grossgmain; 🇦🇹 Grossgmain, Salzburg, Austria