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

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ClinicalTrials.gov Identifier: NCT01033591
Recruitment Status : Unknown
Verified December 2014 by Jesus Torcal Laguna, Basque Health Service.
Recruitment status was:  Active, not recruiting
First Posted : December 16, 2009
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Health Related Quality of Life ( SF36 and 'Minnesota Living with Heart Failure Questionnaire') [ Time Frame: One year follow up ]
    The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and MLHFQ. Both questionnaires will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. The 21 items from the MLHFQ record the perception of the patient in relation to how the HF affects the emotional, social, physical and mental dimensions of their HRQL. Both questionnaires have been validated in the Spanish population.

Secondary Outcome Measures :
  1. Change in functional capacity (6 Minute Walking Test) [ Time Frame: One year follow up ]
    The Test of the 6-minute applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with moderate to severe HF. Most of the daily activities that the patients with IC are performed at submaximal exercise intensity, similar to this test is performed. In addition, as a method of controlling the intensity, this test is recommended using a Borg scale between "relatively easy" and "slightly hard"

  2. Cardiac structural changes (B-type natriuretic peptide) [ Time Frame: One year follow up ]
    Cardiac structural changes (levels of natriuretic peptide predictor)

  3. Muscle strength (dynamometer) [ Time Frame: One year follow-up ]
    Muscle strength was measured with a handgrip dynamometer adjustable (TKK-5001) in four measurements: baseline, at the end of the exercise program, at 6 and 12 months. The hand grip dynamometry is an objective method for measuring muscle strength and an indicator of the functional integrity of the upper extremity that correlates with overall body strength

  4. Body composition (fat and muscular weight) [ Time Frame: One year follow up ]
    Body Mass Index (BMI): Diagnoses and classifies obesity. Also called Quetelet index, is calculated with the values of the weight in kg and height in meters. BMI = weight / (height)

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 and ≤85 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 < 50%.
  • NYHA functional class II-IV, or Stages 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.
  • 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.
  • Obtain at least 4 METS at Naughton exercise test
  • 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.
  • Current or planned pregnancy in the next year
  • Aortic stenosis or severe valve disease
  • Perform an exercise equivalent to the proposed
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033591

Primary Care Research Unit of Bizkaia (Basque Health Service)
Bilbao, Bizkaia, Spain
Sponsors and Collaborators
Basque Health Service
Carlos III Health Institute
Preventive Services and Health Promotion Research Network
Castilla-La Mancha Health Service
Castilla-León Health Service
Public Health Service of Cataluña
Islas Baleares Health Service.
Principal Investigator: Jesus Torcal, Dr. Basauri Health Center. Basque Health Service
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesus Torcal Laguna, general practitioner, Basque Health Service
ClinicalTrials.gov Identifier: NCT01033591     History of Changes
Other Study ID Numbers: EFICAR PS09/01498 -RD06/0018
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases