Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.
• Поведенческое 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.
• Другое Diet management
  A dietary plan supported by a nutritionist will be made together with the patient.
• Другое Resistance exercise
  Resistance exercises: * With TheraBand. * Intensity according to the perceived exertion scale * Twice a week.
• Другое 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.
• Другое Initial Assessment
  Includes all those necessary to plan exercise training, as usual: * Functional capacity with 6MWT. * Assessment of skeletal muscle strength.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Чили · 4 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT06313684 · Fondecyt 1230787

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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