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

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation2 sites in 1 country16 target enrollmentJanuary 2015

ConditionsHeart Failure Depressive Symptoms

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
Enrollment: 16
Locations: 2
Primary Endpoint: inflammatory activity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

February 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Responsible Party

Principal Investigator

Dr. Katherine Wachmann

Study coordinator

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Eligibility Criteria

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