Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia
- Conditions
- Physical ExerciseMyocardial Ischemia
- Registration Number
- NCT04251611
- Lead Sponsor
- Núria Santaularia Capdevila
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The physical exercise minutes performed by the patient per week 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 Outcome Measures
Name Time Method The abdominal circumference At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Abdominal circumference is the measurement of the abdomen of the patient at the level of the navel. It will be recorded in centimeters using a tape measure.
Basal plasma glucose At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
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. Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test.
The body mass index (BMI) At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. BMI is the quotient between the weight (kg) and the square of the height (m). It is usually used for the definition of underweight (BMI \<15.99), normal weight (BMI 18.5 to 24.99), overweight (BMI ≥ 25 kg / m2) and obesity (BMI ≥ 30 kg / m2).
The control of smoking At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test.
Diastolic blood pressure At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
Total cholesterol At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
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. The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.
Systolic blood pressure At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
High-density lipoproteins cholesterol At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
Low-density lipoproteins cholesterol At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
Triglycerides At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. Physiological parameter
Assess the adherence to cardiovascular medication. At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test.
Trial Locations
- Locations (1)
Althaia Xarxa Assistencial Universitària de Manresa
🇪🇸Manresa, Barcelona, Spain
Althaia Xarxa Assistencial Universitària de Manresa🇪🇸Manresa, Barcelona, Spain