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

NCT ID: NCT02358525

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Heart Failure; Depressive Symptoms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

OTHER

Sponsor Role: lead

Responsible Party

Dr. Katherine Wachmann

Study coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

katherine wachmann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann IRBR

Locations

Ska Rz Grossgmain

Grossgmain, Salzburg, Austria

SALK, 2.Medizin, HI-Ambulanz

Salzburg, Salzburg, Austria

Countries

Austria

Other Identifiers

J3256

Identifier Type: -

Identifier Source: org_study_id