Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia (CarPE3)

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)

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 Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Physical Exercise
• Intervention / Treatment: Other: Maintenance of physical exercise

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Althaia Xarxa Assistencial Universitària de Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The usual care in patients with myocardial ischemia without other cardiovascular risk factors (CVFR) will be to attend one visit per year with doctor and nurse of the local health center. In this visit, it will be done a blood test and an electrocardiogram. Blood pressure, weight, body mass index, abdominal circumference will be measured and, in case of detecting enolic habit, smoking or sedentary lifestyle, generic advice will be done. If the patient, apart from myocardial ischemia, presents diabetes mellitus type 2, 3-4 follow-up visits per year will be recommended and will be increased according to specific needs. In case of presenting hypertension, will be recommended 2 visits with the nurse and one visit with the doctor per year and will be increased according to specific needs. In addition, in this case the blood pressure is checked every 6 months. During all visits, professionals will reinforce the control of CVRF and the maintenance of a long-term cardio-healthy lifestyle.
Experimental: Intervention group; Patient will go to health center to visit the cardiac rehabilitation (CR) reference team, which is composed for a doctor and a nurse. This team will establish the guideline of action in the maintenance and/or increase in the physical exercise practice, in function of the resources of each zone and the preferences and motivations of the patient. They also reinforce the control of CVRF and the maintenance of a long-term cardio-healthy lifestyle. At the end of the visit, control visit will be given with the CR reference team at 3, 6 and 12 months after completing the supervised physical exercise program of phase II of the CRP. In case of detecting specific needs for the patient and/or relapses, the team will consult with the appropriate professional (cardiologist, cardiology nurse, physiotherapist, rehabilitator, nutritionist and/or psychologist). At the same time, the patient will be informed of the possibility of re-evaluating the CR reference team.	Other: Maintenance 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.; Other Names: Strengthen the control of cardiovascular risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The physical exercise minutes performed by the patient per week	The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At 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	The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At 6 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	The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The energy expenditure by the patient per week	The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
The energy expenditure by the patient per week	The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
The energy expenditure by the patient per week	The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The body mass index (BMI)	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).	At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
The body mass index (BMI)	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).	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The abdominal circumference	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.	At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
The abdominal circumference	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.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking	Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test.	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking	Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test.	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking	Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose	Physiological parameter	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.	Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test.	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
The quality of life related to health.	Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test.	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
The quality of life related to health.	Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Assess the adherence to cardiovascular medication.	It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test.	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Assess the adherence to cardiovascular medication.	It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test.	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Assess the adherence to cardiovascular medication.	It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test.	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

Collaborators and Investigators

• Sponsor: Núria Santaularia Capdevila
• Collaborators: Institut Català de la Salut
• Investigators: Principal Investigator: Núria Santaularia, MSc, PhD, Althaia Xarxa Assistencial Universitària de Manresa

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Cardiac Rehabilitation; Myocardial Ischemia; Physical Exercise; Cardiovascular Risk Factors
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: CEIC 18/82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with a request of researchers. All the information will be anonymous.
• IPD Sharing Time Frame: When final results of the study will be published.
• IPD Sharing Access Criteria: Data will be shared with researchers or research team with a protocol study approved and/or with a clinical trial registred at a clinical trial register.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No