Hybrid Cardiac Rehabilitation Trial

NCT03881150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-05-10

No results posted yet for this study

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

Interventions

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

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 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

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.

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.

Sponsors & Collaborators

  • Universidad de La Frontera

    lead OTHER

Principal Investigators

  • Pamela J Seron, PhD · Universidad de La Frontera

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-04-05
Completion
2022-05-30

Countries

  • Chile

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881150 on ClinicalTrials.gov