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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358525
• Other study ID #: J3256
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: March 1, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depressive Symptoms
• Heart Failure

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Austria	Ska Rz Grossgmain	Grossgmain	Salzburg
Austria	SALK, 2.Medizin, HI-Ambulanz	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory activity	levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1	8 weeks	No
Secondary	physical fitness	6-min-walk test	8 weeks	No
Secondary	Quality of Life	questionnaires: SF-36 (short-form-36), KCCQ (Kansas City Cardiomyopathy Questionnaire), EQoL-5D (European Quality of LIfe-5Dimensions)	8 weeks	No
Secondary	Depressive Symptoms	questionnaire: HADS (Hospital Anxiety and Depression Scale)	8 weeks	No