Effects of a Rehabilitation Program on Immune Activation... | NCT02358525

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Nov 19, 2014

First Submission Date that Met QC Criteria

Feb 3, 2015

First Posted Date

Feb 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2016

Last Update Posted Date

Mar 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Katherine Wachmann, Study coordinator, Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und RehabilitationPrincipal Investigator

Lead Sponsor

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und RehabilitationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
physical fitness	6-min-walk test	8 weeks
Quality of Life	questionnaires: SF-36 (short-form-36), KCCQ (Kansas City Cardiomyopathy Questionnaire), EQoL-5D (European Quality of LIfe-5Dimensions)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ska Rz Grossgmain		Grossgmain	State of Salzburg	5084	Austria
SALK, 2.Medizin, HI-Ambulanz

ID	Term
D006333	Heart Failure
D003863	Depression

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001526	Behavioral Symptoms
D001519	Behavior