Clinical trial NCT03881150: Hybrid Cardiac Rehabilitation Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: Cardiac rehabilitation
Exercise
Coronary Artery Disease
Mobile technology
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent cardiovascular events
timeFrame: 12 months (or more for first recruited participants, but until 36 months).
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
measure: Functional exercise capacity
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
measure: Grip strength
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
measure: Adherence to physical activity recommendations
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
measure: Adherence to diet recommendations
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.
measure: Return-to-work
timeFrame: End of intervention (8-12 weeks), 6 months, and 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
measure: Waist circumference
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
measure: Blood Pressure
timeFrame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months
measure: Adherence
timeFrame: End of intervention (8-12 weeks)
measure: Exercise related adverse events
timeFrame: End of intervention (8-12 weeks)
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
state: Araucanía
city: Antofagasta
country: Chile
facility: Hospital Regional de Antofagasta
city: Santiago
country: Chile
facility: Complejo Hospitalario San José
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Santiago
country: Chile
facility: Hospital San Borja Arriarán
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
Study officials:
affiliation: Universidad de La Frontera
name: Pamela J Seron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seron P, Oliveros MJ, Marzuca-Nassr GN, Lanas F, Morales G, Roman C, Munoz SR, Saavedra N, Grace SL. Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America. BMJ Open. 2019 Oct 28;9(10):e031213. doi: 10.1136/bmjopen-2019-031213.