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Completed

NCT Number: NCT04251611

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

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.

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Key information

Conditions

Myocardial Ischemia Behavior Cardiovascular Diseases Heart Diseases Motor Activity Physical Exercise Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maintenance of physical exercise

Other

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

Primary outcomes

  1. The physical exercise minutes performed by the patient per week

    Time frame: 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 will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.

  2. The physical exercise minutes performed by the patient per week

    Time frame: 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 will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.

  3. The physical exercise minutes performed by the patient per week

    Time frame: 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 outcomes

  1. The energy expenditure by the patient per week

    Time frame: 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 will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.

  2. The energy expenditure by the patient per week

    Time frame: 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 will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.

  3. The energy expenditure by the patient per week

    Time frame: 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.

  4. The body mass index (BMI)

    Time frame: 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).

  5. The body mass index (BMI)

    Time frame: 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).

  6. The abdominal circumference

    Time frame: At 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.

  7. The abdominal circumference

    Time frame: 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.

  8. The control of smoking

    Time frame: At 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.

  9. The control of smoking

    Time frame: At 6 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.

  10. The control of smoking

    Time frame: 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.

  11. Systolic blood pressure

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  12. Systolic blood pressure

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  13. Systolic blood pressure

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  14. Diastolic blood pressure

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  15. Diastolic blood pressure

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  16. Diastolic blood pressure

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  17. Total cholesterol

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  18. Total cholesterol

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  19. Total cholesterol

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  20. Low-density lipoproteins cholesterol

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  21. Low-density lipoproteins cholesterol

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  22. Low-density lipoproteins cholesterol

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  23. High-density lipoproteins cholesterol

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  24. High-density lipoproteins cholesterol

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  25. High-density lipoproteins cholesterol

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  26. Triglycerides

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  27. Triglycerides

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  28. Triglycerides

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  29. Basal plasma glucose

    Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  30. Basal plasma glucose

    Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  31. Basal plasma glucose

    Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.

    Physiological parameter

  32. The quality of life related to health.

    Time frame: 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.

  33. The quality of life related to health.

    Time frame: At 6 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.

  34. The quality of life related to health.

    Time frame: 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.

  35. Assess the adherence to cardiovascular medication.

    Time frame: 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.

  36. Assess the adherence to cardiovascular medication.

    Time frame: At 6 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.

  37. Assess the adherence to cardiovascular medication.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Núria Santaularia Capdevila

Other

Collaborators

  • Institut Català de la Salut

Registry information

Official study 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)

Acronym: CarPE3

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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