Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure (COCREATIONHF)

Universidad de La Frontera

Status

Enrolling

Conditions

Heart Failure NYHA Class II

Heart Failure NYHA Class III

Treatments

Other: Resistance exercise

Other: Continuous exercise

Other: Comprehensive Initial Assessment

Other: Continuous evaluation

Behavioral: Psychosocial support

Other: Diet management

Other: Interval Exercise

Other: Initial Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT06313684

Fondecyt 1230787

Details and patient eligibility

About

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

Full 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.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients with HF of New York Heart Association functional class II or III.
Meets HF diagnostic criteria of Guidelines
On optimal tolerated medical therapy.
Deemed by the treating physician as stable for at least 1 month.
Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months
Owns a mobile phone
Patient consents to participate in the study by signing an informed consent form.

Exclusion criteria

Chronic kidney disease with glomerular filtration rate < 20 mL/min.
Decompensated thyroid disease.
End-stage liver failure or Child-Pugh C.
Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.
Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).
Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.
Active neoplasm with life expectancy <2 years.
Inclusion in another interventional study.
Explicit contraindications to performing exercise.
Comorbidities that preclude the patient from engaging in a CR program.
Musculoskeletal or neurological disease that precludes the patient from performing exercise.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 2 patient groups

Comprehensive Hybrid Cardiac Rehabilitation

Experimental group

Description:

The 24-week Cardiac Rehabilitation intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a health center, transitioning to home in 4 stages.

Treatment: