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Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04251611
Acronym
CarPE3
Enrollment
101
Registered
2020-02-05
Start date
2019-10-01
Completion date
2022-05-30
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia, Physical Exercise

Keywords

Cardiac Rehabilitation, Myocardial Ischemia, Physical Exercise, Cardiovascular Risk Factors, Randomized Controlled Trial

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.

Interventions

OTHERMaintenance of physical exercise

Objectives will be established with the patient to increase the practice of physical exercise and reinforce the control of cardiovascular risk factors (CVRF) and the maintenance of a long-term cardio-healthy lifestyle.

Sponsors

Institut Català de la Salut
CollaboratorOTHER
Núria Santaularia Capdevila
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The physical exercise minutes performed by the patient per weekAt baseline, when 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

MeasureTime frameDescription
Low-density lipoproteins cholesterolAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
The energy expenditure by the patient per weekAt baseline, when 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.
The body mass index (BMI)At baseline 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 abdominal circumferenceAt baseline 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.
The control of smokingAt baseline, when 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.
Systolic blood pressureAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
High-density lipoproteins cholesterolAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
Total cholesterolAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
TriglyceridesAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
Basal plasma glucoseAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter
The quality of life related to health.At baseline, when 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.
Assess the adherence to cardiovascular medication.At baseline, when 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.
Diastolic blood pressureAt baseline, when the supervised physical exercise program of phase II of the CRP has been completed.Physiological parameter

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026