Clinical trial NCT04251611: Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Physical Exercise
Keywords: Cardiac Rehabilitation
Myocardial Ischemia
Physical Exercise
Cardiovascular Risk Factors
Randomized Controlled Trial
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2020-02-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The physical exercise minutes performed by the patient per week
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: The physical exercise minutes performed by the patient per week
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The physical exercise minutes performed by the patient per week
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary outcomes:
measure: The energy expenditure by the patient per week
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: The energy expenditure by the patient per week
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The energy expenditure by the patient per week
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The body mass index (BMI)
timeFrame: At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The body mass index (BMI)
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The abdominal circumference
timeFrame: At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The abdominal circumference
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The control of smoking
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: The control of smoking
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The control of smoking
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Systolic blood pressure
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Systolic blood pressure
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Systolic blood pressure
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Diastolic blood pressure
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Diastolic blood pressure
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Diastolic blood pressure
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Total cholesterol
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Total cholesterol
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Total cholesterol
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Low-density lipoproteins cholesterol
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Low-density lipoproteins cholesterol
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Low-density lipoproteins cholesterol
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: High-density lipoproteins cholesterol
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: High-density lipoproteins cholesterol
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: High-density lipoproteins cholesterol
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Triglycerides
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Triglycerides
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Triglycerides
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Basal plasma glucose
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Basal plasma glucose
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Basal plasma glucose
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The quality of life related to health.
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: The quality of life related to health.
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: The quality of life related to health.
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Assess the adherence to cardiovascular medication.
timeFrame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
measure: Assess the adherence to cardiovascular medication.
timeFrame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
measure: Assess the adherence to cardiovascular medication.
timeFrame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Núria Santaularia, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: