Coronary Artery Disease, Acute Coronary Syndrome
Conditions
Keywords
Cardiac rehabilitation, Exercise, Coronary Artery Disease, Mobile technology
Brief summary
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.
Detailed description
Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program. Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome. Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers.
Interventions
OTHERComprehensive assessment
Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.
OTHERCounseling
Physical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling.
OTHERGroup education
Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.
OTHERExercise sessions in hybrid program
10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated. Intensity of exercise will be moderate.
OTHERExercise sessions in standard program
18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group. Intensity of exercise will be moderate.
OTHERTransition to unsupervised phase
After 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence.
Sponsors
Universidad de La Frontera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent cardiovascular events | 12 months (or more for first recruited participants, but until 36 months). | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | In meters (mts) obtained in the 6 Minute Walking Test |
| Grip strength | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | In kilograms (kgs) obtained by dynamometry |
| Adherence to physical activity recommendations | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | 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. |
| Adherence to diet recommendations | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | 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. |
| Return-to-work | End of intervention (8-12 weeks), 6 months, and 12 months | Concordance between desired and actual work status at assessment |
| Health-related quality of life | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. | HeartQoL as disease-specific and EuroQol five-dimensional three-level (EQ-5D-3L) as generic instrument will be administered |
| Waist circumference | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | In centimeters (cms) |
| Blood Pressure | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | In millimeters of mercury (mmHg) |
| Adherence | End of intervention (8-12 weeks) | Percentage of attendance at supervised sessions planned. Also adherence to the calls in the intervention group will be collect. |
| Exercise related adverse events | End of intervention (8-12 weeks) | 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. |
| Body Mass Index (BMI) | Baseline, end of intervention (8-12 weeks), 6 months, and 12 months | Weight and height will be combined to report BMI in kg/m2 |
Countries
Chile
Outcome results
None listed