NCT06313684

Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Universidad de La Frontera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings. A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned. The experimental intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness, functional capacity, and quality of life. These will be measured at baseline, end of intervention, and 12-month follow-up. The pragmatic, comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2024-03-15
• Last updated: 2024-12-03

Locations

4 sites across 1 country: Chile