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Hybrid Cardiac Rehabilitation Trial (HYCARET)

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ClinicalTrials.gov Identifier: NCT03881150
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pamela Serón, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Other: Comprehensive assessment Other: Counseling Other: Group education Other: Exercise sessions in hybrid program Other: Exercise sessions in standard program Other: Transition to unsupervised phase Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hybrid Cardiac Rehabilitation

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
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.

Other: 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.

Other: 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.


Other: 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.

Active Comparator: Standard Cardiac Rehabilitation
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
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.

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

Other: 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.





Primary Outcome Measures :
  1. Recurrent cardiovascular events [ Time Frame: 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 :
  1. Health-related quality of life [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months. ]
    EuroQol five-dimensional three-level (EQ-5D-3L) instrument will be administered

  2. Exercise capacity [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months ]
    In meters (mts) obtained in the 6 Minute Walking Test

  3. Adherence to physical activity recommendations [ Time Frame: 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.

  4. Adherence to diet recommendations [ Time Frame: 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.

  5. Body Mass Index (BMI) [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months ]
    Weight and height will be combined to report BMI in kg/m2

  6. Waist circumference [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months ]
    In centimeters (cms)

  7. Blood Pressure [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months ]
    In millimeters of mercury (mmHg)

  8. Grip strength [ Time Frame: Baseline, end of intervention (8-12 weeks), 6 months, and 12 months ]
    In kilograms (kgs) obtained by dynamometry

  9. Adherence [ Time Frame: 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.

  10. Exercise related adverse events [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881150


Contacts
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Contact: María J Oliveros, MSc 56452325765 mariajose.oliveros@ufrontera.cl
Contact: Gabriel N Marzuca, PhD 56452596713 gabriel.marzuca@ufrontera.cl

Locations
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Chile
Universidad de La Frontera Not yet recruiting
Temuco, Araucanía, Chile, 4781176
Contact: María J Oliveros, MSc    56452325765    mariajose.oliveros@ufrontera.cl   
Contact: Gabriel N Marzuca, PhD    56452596713    gabriel.marzuca@ufrontera.cl   
Hospital Regional de Antofagasta Not yet recruiting
Antofagasta, Chile
Contact: Tania Marileo    56954081224    tania.marileo@gmail.com   
Complejo Hospitalario San José Not yet recruiting
Santiago, Chile
Contact: Manuel Galvez    56942293780    manuel.galvez.reyes@gmail.com   
Hospital Clínico Universidad de Chile Not yet recruiting
Santiago, Chile
Contact: Rocío Navarro    56994993360    rocionavarroa@gmail.com   
Hospital San Borja Arriarán Not yet recruiting
Santiago, Chile
Contact: Gonzalo Latin    56985054900    gonzalolatin@gmail.com   
Hospital San Juan de Dios Not yet recruiting
Santiago, Chile
Contact: Juan P Molina    56994990515    jpmolinaf@hotmail.com   
Sponsors and Collaborators
Universidad de la Frontera
Investigators
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Principal Investigator: Pamela J Seron, PhD Universidad de la Frontera

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Responsible Party: Pamela Serón, Professor, Universidad de la Frontera
ClinicalTrials.gov Identifier: NCT03881150     History of Changes
Other Study ID Numbers: Fondecyt 1181734
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: 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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela Serón, Universidad de la Frontera:
Cardiac rehabilitation
Exercise
Coronary Artery Disease
Mobile technology

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases