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

March 1, 2016 updated by: Dr. Katherine Wachmann, Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • SALK, 2.Medizin, HI-Ambulanz
    • Salzburg
      • Grossgmain, Salzburg, Austria, 5084
        • Ska Rz Grossgmain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients, EF ≤ 45%, NYHA I - III; ACC/AHA stage C

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Investigators

  • Principal Investigator: katherine wachmann, Dr., Ludwig Boltzmann IRBR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J3256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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