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

NCT01033591 | Unknown Phase 3

• 1 other identifier: EFICAR PS09/01498 -RD06/0018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Primary Health Care; Family PractiCe; Hearth Failure; Exercise; Randomized Controlled Trials; Multicenter Study; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  One year follow up

Secondary Outcomes (4)

• Change in functional capacity (6 Minute Walking Test)

  One year follow up

• Cardiac structural changes (B-type natriuretic peptide)

  One year follow up

• Muscle strength (dynamometer)

  One year follow-up

• Body composition (fat and muscular weight)

  One year follow up

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

OTHER

Optimized treatment according to the European Society of Cardiology guidelines

Behavioral: Optimized treatment according to the European Society of Cardiology guidelines

Interventions

Supervised progressive exercise program with an aerobic and a strength component + Optimized treatment BEHAVIORAL

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

Exercise

Optimized treatment according to the European Society of Cardiology guidelines BEHAVIORAL

Optimized treatment according to the European Society of Cardiology guidelines

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Basque Health Service: lead
• Carlos III Health Institute: collaborator
• Preventive Services and Health Promotion Research Network: collaborator
• Castilla-La Mancha Health Service: collaborator
• Castilla-León Health Service: collaborator
• Public Health Service of Cataluña: collaborator
• Islas Baleares Health Service.: collaborator

Study Sites (1)

Primary Care Research Unit of Bizkaia (Basque Health Service)

Bilbao, Bizkaia, Spain

Location

Related Publications (1)

• 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.

  PMID: 20100317 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Jesus Torcal, Dr.

  Basauri Health Center. Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general practitioner

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

ES (1)