RecruitingNot ApplicableNCT06313684

Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients

Sponsor

Universidad de La Frontera

Enrollment

152 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure NYHA Class III Heart Failure NYHA Class II

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hybrid cardiac rehabilitation program — combining in-person exercise sessions at a health center with remote monitoring via a mobile phone — for patients with heart failure. Researchers want to see if this blended approach improves heart function, fitness, and quality of life. **You may be eligible if...** - You are an adult with heart failure classified as moderate (NYHA class II or III) - You have been diagnosed with heart failure according to current clinical guidelines - You are on the best available medications for your heart failure - Your condition has been stable for at least 1 month - You own a mobile phone and can attend the health center 3 times per week for the first month, then twice per week for months 2 and 3 **You may NOT be eligible if...** - You have severe kidney disease (GFR less than 20 mL/min) - You have uncontrolled thyroid disease or severe liver failure - You had heart surgery or a device implanted in the past month, or have one planned in the next 3 months - Your shortness of breath is mainly due to a non-heart cause Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERComprehensive 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.

OTHERContinuous 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.

OTHERInterval 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.

BEHAVIORALPsychosocial 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.

OTHERDiet management

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

OTHERResistance exercise

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

OTHERContinuous 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.

OTHERInitial Assessment

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