Myocardial IschemiaCarPE3NCT04251611
Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia
A study testing Maintenance of physical exercise in people with Myocardial Ischemia and Physical Exercise, run by Núria Santaularia Capdevila at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Physical Exercise
- What is being tested?
- Maintenance of physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
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)
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
- Being tested
- Maintenance of physical exercise
- Keywords
- Cardiac Rehabilitation, Myocardial Ischemia, Physical Exercise, Cardiovascular Risk Factors, Randomized Controlled Trial
- Medical subject headings
- Myocardial Ischemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance of physical exerciseOther
Also called Strengthen the control of cardiovascular risk factors
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Maintenance of physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Physiological parameter
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Physiological parameter
Measured: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Physiological parameter
Measured: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Physiological parameter
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Oct 2019
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Núria Santaularia Capdevila
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor-investigator, Núria Santaularia Capdevila, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Núria Santaularia, MSc, PhD, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251611
- Sponsor's protocol ID
- CEIC 18/82
- Acronym
- CarPE3
- Status last verified
- Jun 2022
- First submitted
- 19 Jul 2019
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with a request of researchers. All the information will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04251611
- Acronym / sponsor ID
- CarPE3 / CEIC 18/82
- Conditions
- Myocardial Ischemia, Physical Exercise
- Keywords
- Cardiac Rehabilitation, Myocardial Ischemia, Physical Exercise, Cardiovascular Risk Factors, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Núria Santaularia CapdevilaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Maintenance of physical exercisePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance of physical exerciseAlso: Strengthen the control of cardiovascular risk factorsObjectives 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 | Intervention group |
Primary outcome
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.
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.
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.
37 secondary outcomes
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
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
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The body mass index (BMI)
Time frame: At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
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.
The abdominal circumference
Time frame: At baseline of the supervised physical exercise program of phase II of the CRP has been completed.
The abdominal circumference
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
The control of smoking
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Systolic blood pressure
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Diastolic blood pressure
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Total cholesterol
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Low-density lipoproteins cholesterol
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
High-density lipoproteins cholesterol
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Triglycerides
Time frame: At 12 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Time frame: At 6 months of the supervised physical exercise program of phase II of the CRP has been completed.
Basal plasma glucose
Time frame: 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.
Time frame: At baseline, when the supervised physical exercise program of phase II of the CRP has been completed.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: Yes. Data will be shared with a request of researchers. All the information will be anonymous.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Núria Santaularia, MSc, PhD principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance of physical exercise in people with Myocardial Ischemia and Physical Exercise, run by Núria Santaularia Capdevila at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.