Heart FailurePhase 3EFICARNCT01033591
Exercise for Patients With Heart Failure in Primary Care: the EFICAR
A Phase 3 study testing Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment and Optimized treatment according to the European Society of Cardiology guidelines in people with Heart Failure, run by Basque Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment and Optimized treatment according to the European Society of Cardiology guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Care Research Unit of Bizkaia (Basque Health Service)
Bilbao, Bizkaia
About this study
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
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.
Read the detailed description
Multicenter clinical trial in which 150 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.
Protocol for the intervention group The EFICAR group differs from the control group only in terms of the exercise programme, which has two phases. The exercise programme is a combination of "high-intensity interval training" and "muscular strength training". It has been demonstrated that high intensity aerobic exercise leads to better aerobic and cardiovascular changes than light/moderate exercise in patients with HF • 1st PHASE (12 weeks, 3 sessions/week): for the first three months, patients carry out a progressive exercise programme of 36 sessions under the supervision of the nurse, starting at low intensity (first month) and increasing it month by month.
Aerobic training: Aerobic exercise is undertaken on a cycloergometer, including warm-up, conditioning and cool down phase. From the beginning, the exercise sessions are personalised according to the physical condition of each patient. The first month is for "start-up", the second for "progress" and the third for "maintenance". For those patients that are very weak or are not used to aerobic exercise, the first sessions are of light-to-moderate intensity.
The Borg scale is used to evaluate the "perception of effort" during and after each session (values ranging between 6 and 20). This is a very useful scale to determine intensity with beta blockers, auricular fibrillation, pace-makers or other conditions which may alter the normal response of the heart rate to exercise. The exercise is also monitored with respect to the emergence of symptoms. Aerobic exercise is done before the strength training to guarantee activation of the muscles and cardiovascular system.
Muscular strength training: muscular strength work is a essential aspect of the rehabilitation of patients with HF. To avoid training-related increase of the hemodynamic load the exercise is isotonic. In each session, after 5 min of stretching and 8-12 min of aerobic exercise, six types of exercise are carried out to work various muscle groups: biceps, upper arms and shoulders, knee extensors and flexors, hip flexors and extensors, and plantar flexors. For muscular strength training, weights are used for upper body and resistance bands for the lower body. A different percentage of body weight is applied for each muscular group. Each patient is regularly informed of the progress they have made.
- 2nd PHASE: The training given in the first phase is intended to ensure that the patients make this exercise part of their routine. They are trained to carry out a type of interval aerobic exercise to they can keep up in their own environment, indefinitely and independently, together with muscular strength exercises. In addition, they are taught how to self-regulate the exercise intensity (Borg Scale, pulsometers, symptoms).
- Conditions
- Heart Failure
- Being tested
- Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment, Optimized treatment according to the European Society of Cardiology guidelines
- Keywords
- Primary Health Care, Family PractiCe, Hearth Failure, Exercise, Randomized Controlled Trials, Multicenter Study, Quality of life
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised progressive exercise program with an aerobic and a strength component + Optimized treatmentBehavioural
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 guidelinesBehavioural
Optimized treatment according to the European Society of Cardiology guidelines
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Supervised exercise + Optimized treatment according to the European Society of Cardiology guidelines Receives: Behavioral: Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment |
| Control | Other | Optimized treatment according to the European Society of Cardiology guidelines Receives: Behavioral: Optimized treatment according to the European Society of Cardiology guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Related Quality of Life ( SF36 and 'Minnesota Living with Heart Failure Questionnaire')
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.
Measured: One year follow up
Secondary outcomes (4)
Change in functional capacity (6 Minute Walking Test)
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"
Measured: One year follow up
Cardiac structural changes (B-type natriuretic peptide)
Cardiac structural changes (levels of natriuretic peptide predictor)
Measured: One year follow up
Muscle strength (dynamometer)
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
Measured: One year follow-up
Body composition (fat and muscular weight)
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)
Measured: One year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2011
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- 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.
- Responsible party
- Principal investigator, Jesus Torcal Laguna, Basque Health Service
- Investigators
- Jesus Torcal, Dr., Principal investigator, Basauri Health Center. Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033591
- Sponsor's protocol ID
- EFICAR PS09/01498 -RD06/0018
- Acronym
- EFICAR
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2009
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zuazagoitia A, Grandes G, Torcal J, Lekuona I, Echevarria P, Gomez MA, Domingo M, de la Torre MM, Ramirez JI, Montoya I, Oyanguren J, Pinilla RO; EFICAR Group (Ejercicio Fisico en la Insuficiencia Cardiaca). 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. BMC Public Health. 2010 Jan 25;10:33. doi: 10.1186/1471-2458-10-33.
PubMed 20100317
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01033591
- Acronym / sponsor ID
- EFICAR / EFICAR PS09/01498 -RD06/0018
- Conditions
- Heart Failure
- Keywords
- Primary Health Care, Family PractiCe, Hearth Failure, Exercise, Randomized Controlled Trials, Multicenter Study, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- 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.
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multicenter clinical trial in which 150 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.
Protocol for the intervention group The EFICAR group differs from the control group only in terms of the exercise programme, which has two phases. The exercise programme is a combination of "high-intensity interval training" and "muscular strength training". It has been demonstrated that high intensity aerobic exercise leads to better aerobic and cardiovascular changes than light/moderate exercise in patients with HF • 1st PHASE (12 weeks, 3 sessions/week): for the first three months, patients carry out a progressive exercise programme of 36 sessions under the supervision of the nurse, starting at low intensity (first month) and increasing it month by month.
Aerobic training: Aerobic exercise is undertaken on a cycloergometer, including warm-up, conditioning and cool down phase. From the beginning, the exercise sessions are personalised according to the physical condition of each patient. The first month is for "start-up", the second for "progress" and the third for "maintenance". For those patients that are very weak or are not used to aerobic exercise, the first sessions are of light-to-moderate intensity.
The Borg scale is used to evaluate the "perception of effort" during and after each session (values ranging between 6 and 20). This is a very useful scale to determine intensity with beta blockers, auricular fibrillation, pace-makers or other conditions which may alter the normal response of the heart rate to exercise. The exercise is also monitored with respect to the emergence of symptoms. Aerobic exercise is done before the strength training to guarantee activation of the muscles and cardiovascular system.
Muscular strength training: muscular strength work is a essential aspect of the rehabilitation of patients with HF. To avoid training-related increase of the hemodynamic load the exercise is isotonic. In each session, after 5 min of stretching and 8-12 min of aerobic exercise, six types of exercise are carried out to work various muscle groups: biceps, upper arms and shoulders, knee extensors and flexors, hip flexors and extensors, and plantar flexors. For muscular strength training, weights are used for upper body and resistance bands for the lower body. A different percentage of body weight is applied for each muscular group. Each patient is regularly informed of the progress they have made.
- 2nd PHASE: The training given in the first phase is intended to ensure that the patients make this exercise part of their routine. They are trained to carry out a type of interval aerobic exercise to they can keep up in their own environment, indefinitely and independently, together with muscular strength exercises. In addition, they are taught how to self-regulate the exercise intensity (Borg Scale, pulsometers, symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Supervised progressive exercise program with an aerobic and a strength component + Optimized treatmentSupervised exercise + Optimized treatment according to the European Society of Cardiology guidelines |
| Control | Other | Behavioral: Optimized treatment according to the European Society of Cardiology guidelinesOptimized treatment according to the European Society of Cardiology guidelines |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised progressive exercise program with an aerobic and a strength component + Optimized treatmentThree 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 | Behavioural | Exercise |
| Optimized treatment according to the European Society of Cardiology guidelinesOptimized treatment according to the European Society of Cardiology guidelines | Behavioural | Control |
Primary outcome
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.
4 secondary outcomes
Change in functional capacity (6 Minute Walking Test)
Time frame: One year follow up
Cardiac structural changes (B-type natriuretic peptide)
Time frame: One year follow up
Muscle strength (dynamometer)
Time frame: One year follow-up
Body composition (fat and muscular weight)
Time frame: One year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 20100317Zuazagoitia A, Grandes G, Torcal J, Lekuona I, Echevarria P, Gomez MA, Domingo M, de la Torre MM, Ramirez JI, Montoya I, Oyanguren J, Pinilla RO; EFICAR Group (Ejercicio Fisico en la Insuficiencia Cardiaca). 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. BMC Public Health. 2010 Jan 25;10:33. doi: 10.1186/1471-2458-10-33.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Torcal, Dr. principal investigator
Basauri Health Center. Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment and Optimized treatment according to the European Society of Cardiology guidelines in people with Heart Failure, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Related Quality of Life ( SF36 and 'Minnesota Living with Heart Failure Questionnaire') (time frame: One year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.