Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Universidad de La Frontera152 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III

Interventions

Comprehensive Initial AssessmentOTHER

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.

Continuous evaluationOTHER

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.

Interval ExerciseOTHER

High-intensity interval training prescribed by physical therapist: * According to an adapted Wisloff protocol. * Borg scale to monitor intensity. * Training 3 times per week.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Complejo Hospitalario San José

Santiago, Chile

RECRUITING

Hospital Clínico Universidad de Chile

Santiago, Chile

RECRUITING

Hospital San Borja Arriarán

Santiago, Chile

RECRUITING

Outcomes

Primary Outcomes

Cardiorespiratory fitness

Will be assessed during a symptom-limited cardiopulmonary exercise test using an individualized gradual incremental ramp test designed to obtain oxygen consumption (VO2max).

Time frame: Baseline, 6 months and 12 months.

Functional capacity

Will be assessed by the six-minute walk test (6MWT)

Time frame: Baseline, 6 months and 12 months.

Health Related Quality of Life

Will be evaluated with the Minnesota Living with Heart Failure Questionnaire (MLHFQ). This questionnaire has 21 questions, which are answered on a scale of 1 to 5. The score of the questionnaire is obtained by the sum of the answers to the 21 questions, the higher the score, the worse the quality of life.

Time frame: Baseline, 6 months and 12 months.

Secondary Outcomes

Program adherence and completion

Program adherence is defined as the percentage of total prescribed sessions completed. For home-based activities, the percentage of activities carried out at home of the prescribed ones will be computed.

Time frame: 6 months

Concentration of Pro-B-type Natriuretic Peptide

Biomarker with prognostic utility. When it is higher than 1000 pg/mL, there is a higher probability of having events such as hospitalizations.

Time frame: Baseline, 6 months and 12 months.

Functioning

Defined as the ability to perform basic, instrumental and advanced activities of daily living. It will be measured with the Activities of Daily Living Questionnaire - Technology (ADLQ-T). This questionnaire evaluates 7 areas: self-care (6 items), home care and management (6 items), work and recreation (4 items), shopping and money (3 items), travel (3), communication (5 items) and technology (5 items). Each item has a score, where 0 is no problem for the activity up to 3 indicating that he/she cannot perform the activity. The functional deficit is calculated for each area and for the overall questionnaire with the sum of all scores, divided by 3 and then multiplied by the total number of items answered. A higher score indicates greater impairment of ADLs.

Central Contacts

Francisca Contreras

CONTACT

56045 2325765 mariafrancisca.contreras@ufrontera.cl

Data from ClinicalTrials.gov

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