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Completed

NCT Number: NCT02358525

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

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.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Depression Depressive Symptoms Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ska Rz Grossgmain, Grossgmain, State of Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-modality rehabilitation program for heart failure

Behavioral

rehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure

Primary outcomes

  1. inflammatory activity

    Time frame: 8 weeks

    levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1

Secondary outcomes

  1. physical fitness

    Time frame: 8 weeks

    6-min-walk test

  2. 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)

  3. Depressive Symptoms

    Time frame: 8 weeks

    questionnaire: HADS (Hospital Anxiety and Depression Scale)

Sponsors and collaborators

Lead sponsor

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2015
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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