Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Summary

CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.

Conditions

• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Interventions

OTHER

Comprehensive Initial Assessment

Initial Assessment includes all those necessary to prescribe exercise training, as well as dietary and adherence promotion interventions. * Functional capacity with 6MWT * Assessment of skeletal muscle strength, flexibility, and balance. * Assessment of function * Assessment of dietary habits * Assessment of self-efficacy and barriers to CR adherence. * Screening for depression.

OTHER

Continuous evaluation

Evaluations during the course of the program will be carried out to inform the progression through the CR stages, the intensity of training and education needs.

OTHER

Interval Exercise

High-intensity interval training prescribed by physical therapist: * According to an adapted Wisloff protocol. * Borg scale to monitor intensity. * Training 3 times per week.

BEHAVIORAL

Psychosocial support

Based on social-cognitive theory, with self-efficacy as a focus: * Face-to-face sessions in the first stage of the program: Education, self-monitoring and motivational interview. * Face-to-face session in the second stage of the program: promoting behavior changes by self-control and self-monitoring * Regular communication with patients will be supported by the use of mobile devices during the third and fourth stages of program.

OTHER

Diet management

A dietary plan supported by a nutritionist will be made together with the patient.

OTHER

Resistance exercise

Resistance exercises: * With TheraBand. * Intensity according to the perceived exertion scale * Twice a week.

OTHER

Continuous exercise

Moderate-intensity continuous exercise prescribed by physical therapist : * The intensity will be moderate, as tolerated * Borg scale to monitor intensity. * Frequency of training of 1 to 3 times per week, until completed 20 sessions in 10-12 weeks.

OTHER

Initial Assessment

Includes all those necessary to plan exercise training, as usual: * Functional capacity with 6MWT. * Assessment of skeletal muscle strength.

Sponsors & Collaborators

• University of Chile

  collaborator OTHER

• Universidad de La Frontera

  lead OTHER

Principal Investigators

• Pamela Seron, PhD · Universidad de La Frontera

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2026-09-30

Completion

2027-03-31

Countries

• Chile

Study Locations