Coronary Artery Disease Clinical Trial
— HYCARETOfficial title:
Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
Verified date | May 2023 |
Source | Universidad de La Frontera |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.
Status | Completed |
Enrollment | 186 |
Est. completion date | May 30, 2022 |
Est. primary completion date | April 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 year old or over. - Patient with coronary artery disease, including Acute Coronary Syndrome (Unstable Angina, Myocardial infarction with or without ST elevation) or stable coronary vessel disease diagnosed by angiography or a stress test. - Patient treated medically (i.e., medication only) or by thrombolysis, angioplasty, or revascularization surgery. - Patient with physician referral, that can start CR between 2 weeks and 2 months from their event, diagnosis or procedure. - Patient able to attend the health center almost twice a week over three months. - Patient owns a mobile phone. - Patient that consents to participate in the study through signing an informed consent form. Exclusion Criteria: - Patient has a planned repeat cardiac or other procedure in next 12 months. - Explicit contraindication to perform exercise based on American College of Sport Medicine. - Patients with comorbidities that would interfere with ability to engage in cardiac rehabilitation such as dementia, blindness, deafness, serious mental illness, or frailty. - Musculoskeletal disease that precludes the patient from performing exercise |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Regional de Antofagasta | Antofagasta | |
Chile | Complejo Hospitalario San José | Santiago | |
Chile | Hospital Clínico Universidad de Chile | Santiago | |
Chile | Hospital San Borja Arriarán | Santiago | |
Chile | Hospital San Juan de Dios | Santiago | |
Chile | Universidad de La Frontera | Temuco | Araucanía |
Lead Sponsor | Collaborator |
---|---|
Universidad de La Frontera |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrent cardiovascular events | Composite of cardiovascular mortality (defined as death by stroke, myocardial infarction or heart failure) and hospitalizations due to a cardiovascular cause (non-fatal stroke, non-fatal myocardial infarction, heart failure, and need for revascularization surgery) | 12 months (or more for first recruited participants, but until 36 months). | |
Secondary | Health-related quality of life | HeartQoL as disease-specific and EuroQol five-dimensional three-level (EQ-5D-3L) as generic instrument will be administered | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | |
Secondary | Functional exercise capacity | In meters (mts) obtained in the 6 Minute Walking Test | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Grip strength | In kilograms (kgs) obtained by dynamometry | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Adherence to physical activity recommendations | The International Physical Activity Questionnaire (IPAQ) will be administered. This instrument can quantify the energy spent in MET-minutes/week for categorization in accordance with the World Health Organization recommendation: An adults 18 years old or over adheres when perform 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous activity per week, or a combination of both. | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | |
Secondary | Adherence to diet recommendations | Trained personnel will administer the Mediterranean Dietary Index for Chilean population (Chile-MDI). Participants recall the frequency of consumption of 14 food groups. This instrument had been validated. Scores range from 0 to 14 points, indicating absence and maximum adherence, respectively. | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | |
Secondary | Return-to-work | Concordance between desired and actual work status at assessment | End of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m2 | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Waist circumference | In centimeters (cms) | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Blood Pressure | In millimeters of mercury (mmHg) | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | |
Secondary | Adherence | Percentage of attendance at supervised sessions planned. Also adherence to the calls in the intervention group will be collect. | End of intervention (8-12 weeks) | |
Secondary | Exercise related adverse events | Counting adverse events during exercise, such as myocardial ischemia or malignant arrhythmias, will be registered. Serious adverse event, as death in the exercise session, will be registered and reported to corresponding ethic committee and monitor. | End of intervention (8-12 weeks) |
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