Hybrid Cardiac Rehabilitation Trial

NCT03881150 | Completed DMC

• 1 other identifier: Fondecyt 1181734
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Cardiac rehabilitation; Exercise; Coronary Artery Disease; Mobile technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Health-related quality of life

  Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.

• Functional exercise capacity

  Baseline, end of intervention (8-12 weeks), 6 months, and 12 months

• Grip strength

  Baseline, end of intervention (8-12 weeks), 6 months, and 12 months

• Adherence to physical activity recommendations

  Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.

• Adherence to diet recommendations

  Baseline, end of intervention (8-12 weeks), 6 months, and 12 months.

Study Arms (2)

Hybrid Cardiac Rehabilitation

EXPERIMENTAL

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.

Other: Comprehensive assessment; Other: Counseling; Other: Exercise sessions in hybrid program; Other: Transition to unsupervised phase

Standard Cardiac Rehabilitation

ACTIVE COMPARATOR

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).

Other: Comprehensive assessment; Other: Group education; Other: Exercise sessions in standard program

Interventions

Comprehensive assessment OTHER

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.

Hybrid Cardiac Rehabilitation; Standard Cardiac Rehabilitation

Counseling OTHER

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.

Hybrid Cardiac Rehabilitation

Group education OTHER

Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.

Standard Cardiac Rehabilitation

Exercise sessions in hybrid program OTHER

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.

Hybrid Cardiac Rehabilitation

Exercise sessions in standard program OTHER

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.

Standard Cardiac Rehabilitation

Transition to unsupervised phase OTHER

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.

Hybrid Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (6)

Universidad de La Frontera

Temuco, Región de la Araucanía, 4781176, Chile

Location

Hospital Regional de Antofagasta

Antofagasta, Chile

Location

Complejo Hospitalario San José

Santiago, Chile

Location

Hospital Clínico Universidad de Chile

Santiago, Chile

Location

Hospital San Borja Arriarán

Santiago, Chile

Location

Hospital San Juan de Dios

Santiago, Chile

Location

Related Publications (2)

• Seron P, Oliveros MJ, Marzuca-Nassr GN, Morales G, Roman C, Munoz SR, Galvez M, Latin G, Marileo T, Molina JP, Navarro R, Sepulveda P, Lanas F, Saavedra N, Ulloa C, Grace SL; HYCARET Investigators. Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350301. doi: 10.1001/jamanetworkopen.2023.50301.

  PMID: 38194236 DERIVED

• 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.

  PMID: 31662385 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pamela J Seron, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: May 6, 2019
• Primary Completion: April 5, 2021
• Study Completion: May 30, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months following main results article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to Principal Investigator. To gain access, data requestors will need to sign a data access agreement.

Locations

CL (6)