Hybrid Cardiac Rehabilitation Trial

Coronary Artery Disease Clinical Trial

— HYCARET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881150
• Other study ID #: Fondecyt 1181734
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2023
• Source: Universidad de La Frontera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Comprehensive 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.
• Counseling
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.
• Group education
Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.
• Exercise 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.
• Exercise 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.
• Transition 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de La Frontera

Country where clinical trial is conducted

Chile, 

Outcome

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)