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

Myocardial Ischemia Clinical Trial

— CarPE3  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251611
• Other study ID #: CEIC 18/82
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2022
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Physical Exercise

Intervention

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.

Locations

Country	Name	City	State
Spain	Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Núria Santaularia Capdevila	Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Systolic blood pressure	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Systolic blood pressure	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Systolic blood pressure	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Diastolic blood pressure	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Diastolic blood pressure	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Diastolic blood pressure	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Total cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Total cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Total cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Low-density lipoproteins cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Low-density lipoproteins cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Low-density lipoproteins cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	High-density lipoproteins cholesterol	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	High-density lipoproteins cholesterol	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	High-density lipoproteins cholesterol	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Triglycerides	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Triglycerides	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Triglycerides	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Basal plasma glucose	Physiological parameter	At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Basal plasma glucose	Physiological parameter	At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	Basal plasma glucose	Physiological parameter	At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.