Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Official title

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

Overview

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.

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.

Primary outcome measures

• Cardiorespiratory fitness [Time frame: Baseline, 6 months and 12 months.]
• Functional capacity [Time frame: Baseline, 6 months and 12 months.]
• Health Related Quality of Life [Time frame: Baseline, 6 months and 12 months.]

Secondary outcome measures (7)

• Program adherence and completion [Time frame: 6 months]
• Concentration of Pro-B-type Natriuretic Peptide [Time frame: Baseline, 6 months and 12 months.]
• Functioning [Time frame: Baseline, 6 months and 12 months.]
• Mortality and Hospital admission [Time frame: 12 months]
• Upper-body muscle strength [Time frame: Baseline, 6 months and 12 months.]
• Lower-body muscle strength [Time frame: Baseline, 6 months and 12 months.]
• Cost [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Chile · 4 centers

• Complejo Hospitalario San José — Santiago
• Hospital Clínico Universidad de Chile — Santiago
• Hospital San Borja Arriarán — Santiago
• Universidad de La Frontera — Temuco

Publications

• Seron P, Gomez-Perez D, Opazo-Diaz E, Oliveros MJ, Contreras MF, Salinas A, Andrade-Mayorga O, Marzuca-Nassr GN, Saavedra K, Espejo C, Munoz S, Lanas F, Grace SL. CO-CREATION-HF protocol: clinical trial to evaluate the impact of a comprehensive and hybrid cardiac rehabilitation model on patients with heart failure. Front Cardiovasc Med. 2024 Nov 14;11:1427544. doi: 10.3389/fcvm.2024.1427544. eColl PMID 39610971

Identifiers

NCT: NCT06313684 · Fondecyt 1230787

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗