Randomized Clinical Trial by Conglomerates on the Efficacy of the Maintenance of Physical Exercise for Patients With Myocardial Ischemia. Study Cardiopathy Prevention and Exercise in Phase 3 (CarPE3)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 101
- Locations
- 2
- Primary Endpoint
- The physical exercise minutes performed by the patient per week
Study Overview
Brief Summary
Main objective: To assess the efficacy of a phase III cardiac rehabilitation program (CRP), based on counseling in the maintenance of physical exercise (time of physical exercise per week) for patients with myocardial ischemia (MI), once the supervised physical exercise program of phase II of CRP is completed.
Secondary objectives: To assess the efficacy of a phase III program of CRP based on counseling in the maintenance of physical exercise for the patient with MI in: 1) the energy expenditure per week, 2) body mass index and abdominal perimeter, 3) control of cardiovascular risk factors (smoking, high blood pressure, dyslipidemia and diabetes mellitus), 4) quality of life related to health, 5) assess the adherence to cardiac pharmacological treatment.
Method: Randomized clinical trial in conglomerates, open and controlled. The intervention group will carry out phase III of CRP based on counseling in the maintenance of physical exercise. The control group will receive the usual care. The main outcome will be the physical exercise time per week after finish the supervised physical exercise program of phase II of CRP and at 6 and 12 month later according to the 7-day Physical Activity Recall.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with myocardial ischemia, angina pectoris, other specific forms of chronic ischemic heart disease or unspecified ischemic heart disease.
- •Patients who have completed the supervised physical exercise program of phase II of the CRP.
- •Absence of cognitive deficit (Pfeiffer test: 0-2 mistakes).
- •Sufficient functional capacity to follow the CRP (Barthel index >60)
- •Residence in catchment area of Bages and Moianès.
- •Providing signed informed consent.
Exclusion Criteria
- •Symptoms of right heart failure producing pulmonary hypertension.
- •Dyspnea caused by severe pulmonary pathology.
- •Additional comorbidities affecting the prognosis of cardiac disease.
- •Major comorbidities or limitations that could interfere with the exercise training programme.
Outcomes
Primary Outcomes
The physical exercise minutes performed by the patient per week
Time Frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.
Secondary Outcomes
- The abdominal circumference(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Basal plasma glucose(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- The quality of life related to health.(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- The body mass index (BMI)(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- The control of smoking(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Diastolic blood pressure(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Total cholesterol(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- The energy expenditure by the patient per week(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Systolic blood pressure(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- High-density lipoproteins cholesterol(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Low-density lipoproteins cholesterol(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Triglycerides(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
- Assess the adherence to cardiovascular medication.(At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.)
Investigators
Núria Santaularia Capdevila
Principal Investigator
Althaia Xarxa Assistencial Universitària de Manresa