Hybrid Cardiac Rehabilitation Trial

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Other: Comprehensive assessment; Other: Counseling; Other: Group education; Other: Exercise sessions in standard program; Other: Exercise sessions in hybrid program; Other: Transition to unsupervised phase

• Registration Number: NCT03881150
• Lead Sponsor: Universidad de La Frontera

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.

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-05-06
• Primary Completion: 2021-04-05
• Study Completion: 2022-05-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Cardiac Rehabilitation	Counseling	This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology. Counseling is considered about physical activity, diet, smoking, and medication compliance.
Standard Cardiac Rehabilitation	Exercise sessions in standard program	The participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling).
Hybrid Cardiac Rehabilitation	Comprehensive assessment	This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology. Counseling is considered about physical activity, diet, smoking, and medication compliance.
Hybrid Cardiac Rehabilitation	Exercise sessions in hybrid program	This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology. Counseling is considered about physical activity, diet, smoking, and medication compliance.
Hybrid Cardiac Rehabilitation	Transition to unsupervised phase	This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology. Counseling is considered about physical activity, diet, smoking, and medication compliance.
Standard Cardiac Rehabilitation	Comprehensive assessment	The participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling).
Standard Cardiac Rehabilitation	Group education	The participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.
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
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.
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
Grip strength	Baseline, end of intervention (8-12 weeks), 6 months, and 12 months	In kilograms (kgs) obtained by dynamometry
Return-to-work	End of intervention (8-12 weeks), 6 months, and 12 months	Concordance between desired and actual work status at assessment
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.

Trial Locations

Locations (6)

Hospital San Borja Arriarán; 🇨🇱 Santiago, Chile

Complejo Hospitalario San José; 🇨🇱 Santiago, Chile

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Chile

Hospital San Juan de Dios; 🇨🇱 Santiago, Chile

Hospital Regional de Antofagasta; 🇨🇱 Antofagasta, Chile

Universidad de La Frontera; 🇨🇱 Temuco, Araucanía, Chile