Exercise for Patients With Heart Failure in Primary Care: the EFICAR
This study is currently recruiting participants.
Verified May 2011 by Basque Health Service
Sponsor:
Basque Health Service
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
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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 May 23, 2013