Exercise for Patients With Heart Failure in Primary Care: the EFICAR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Basque Health Service.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Carlos III Health Institute
Preventive Services and Health Promotion Research Network
Santa Bárbara and Cuenca primary care centers(Castilla La Mancha Health Service)
Castilla-León Health Service
Public Health Service of Cataluña
Islas Baleares Health Service.
Castilla-La Mancha Health Service.
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01033591
First received: December 15, 2009
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

Quality of life decreases as the heart failure worsens and is one of the biggest worries of these patients. Physical exercise has been shown as a safe intervention for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported that the effects on QoL are inconsistent. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and cardiovascular risk factor control.


Condition Intervention Phase
Heart Failure
Behavioral: Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment
Behavioral: Optimized treatment according to the European Society of Cardiology guidelines
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rationale and Design of a Randomised Controlled Trial Evaluating the Effectiveness of an Exercise Program to Improve the Quality of Life of Patients With Heart Failure in Primary Care: The EFICAR Study Protocol

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Change in Health Related Quality of Life ( SF36 and 'Minnesota Living with Heart Failure Questionnaire') [ Time Frame: One year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in functional capacity (6 Minute Walking Test) [ Time Frame: One year follow up ] [ Designated as safety issue: No ]
  • Cardiac structural changes (B-type natriuretic peptide) [ Time Frame: One year follow up ] [ Designated as safety issue: No ]
  • Muscle strength (dynamometer) [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
  • Body composition (fat and muscular weight) [ Time Frame: One year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Supervised exercise + Optimized treatment according to the European Society of Cardiology guidelines
Behavioral: Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment
Three month supervised progressive exercise program with an aerobic (high intensity intervals) and a strength component; and the programme will continue linked with community resources for 9 months
No Intervention: Control
Optimized treatment according to the European Society of Cardiology guidelines
Behavioral: Optimized treatment according to the European Society of Cardiology guidelines
Optimized treatment according to the European Society of Cardiology guidelines

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of HF on the basis of signs and symptoms (Framingham criteria) and evidence of structural heart alterations detected by echocardiography (Echo). Echo scanning guarantees that we are dealing with patients suffering from HF avoiding confounding clinical factors.
  • Left ventricle ejection fraction < 45%.
  • NYHA functional class II-IV, or Stages B and C of the American Heart Association, in a stable situation for at least the previous four weeks, with no changes in baseline functional status, no signs of congestion or changes in weight faster than 2 kg in three days.
  • Receiving optimal treatment with angiotensin converting enzyme inhibitors (ACEI), angiotensin II receptor antagonists (ARA-II), beta blockers, diuretics, and aldosterone antagonists at stable doses for the previous four weeks, as long as there are no justified contraindications for their use, and meeting the clinical practice guidelines of the European Society of Cardiology [1].
  • Anticoagulated patients without atrial fibrillation, ejection fraction < 30%, presence of intracardiac thrombi, or history of embolism.
  • In cases of sinusal rhythm or atrial fibrillation, ventricular response is under control both at rest and during exercise (90 beats/minute at rest, and 130 beats/minute during moderate exercise).
  • Absence of arrhythmia in exercise stress test that would contraindicate exercise.
  • Able to attend an exercise programme and travel to the reference laboratory.
  • Informed consent confirmed in writing.

Exclusion Criteria:

  • Physical and mental comorbidity which prevents undertaking the exercise programme.
  • Major cardiovascular events (in the previous 6 weeks) or cardiovascular procedures, including cardiac resynchronization or implantation of a defibrillator.
  • Heart failure pending intervention (mitral valve replacement/repair, ventricular reconstruction, pacemaker/ resynchronization pacemaker, implantable defibrillator, transplant), given that the procedures greatly change the baseline functional status and the prognosis of the disease.
  • Heart failure secondary to congenital heart disease or hypertrophic obstructive cardiomyopathy, given that there is a formal contraindication for exercise in such clinical situations.
  • Carrier of a fixed-rate pacemaker.
  • Exercise test that contraindicates exercise for safety reasons, especially in the case of exercise-induced arrhythmia.
  • Poor cognitive state, depression or psychiatric disorder that prevent adherence to an exercise programme.
  • Inability to travelling to the health centre by their own means.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033591

Contacts
Contact: Gonzalo Grandes, Dr. +34 94 600 66 38 GONZALO.GRANDES@osakidetza.net

Locations
Spain
Primary Care Research Unit of Bizkaia (Basque Health Service) Recruiting
Bilbao, Bizkaia, Spain
Sub-Investigator: Gonzalo Grandes, Dr.         
Sponsors and Collaborators
Basque Health Service
Carlos III Health Institute
Preventive Services and Health Promotion Research Network
Santa Bárbara and Cuenca primary care centers(Castilla La Mancha Health Service)
Castilla-León Health Service
Public Health Service of Cataluña
Islas Baleares Health Service.
Castilla-La Mancha Health Service.
Investigators
Principal Investigator: Jesus Torcal, Dr. Basauri Health Center. Basque Health Service
  More Information

No publications provided by Basque Health Service

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesus Torcal, Basque Health Service
ClinicalTrials.gov Identifier: NCT01033591     History of Changes
Other Study ID Numbers: EFICAR PS09/01498 -RD06/0018
Study First Received: December 15, 2009
Last Updated: May 31, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Basque Health Service:
Primary Health Care
Family PractiCe
Hearth Failure
Exercise
Randomized Controlled Trials
Multicenter Study
Quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014