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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02358525

Enrollment

Registered

2015-02-09

Start date

2015-01-31

Completion date

2016-02-29

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, Heart Failure

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.

Interventions

BEHAVIORALmulti-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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026