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

NCT04251611 | Completed

• 1 other identifier: CEIC 18/82
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia; Physical Exercise

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (37)

• The energy expenditure by the patient per week

  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

  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

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

• The body mass index (BMI)

  At baseline of the supervised physical exercise program of phase II of the CRP has been completed.

• The body mass index (BMI)

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

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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

Interventions

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.

Also known as: Strengthen the control of cardiovascular risk factors

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Núria Santaularia Capdevila: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Conditions

Myocardial Ischemia; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Study Officials

• Núria Santaularia, MSc, PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: February 5, 2020
• Study Start: October 1, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When final results of the study will be published.
• 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.

Locations

ES (1)