Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
Universidad de La Frontera
152 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
Summary
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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.
Interventions
A dietary plan supported by a nutritionist will be made together with the patient.
Resistance exercises: * With TheraBand. * Intensity according to the perceived exertion scale * Twice a week.
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.
Includes all those necessary to plan exercise training, as usual: * Functional capacity with 6MWT. * Assessment of skeletal muscle strength.
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.
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.
High-intensity interval training prescribed by physical therapist: * According to an adapted Wisloff protocol. * Borg scale to monitor intensity. * Training 3 times per week.
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.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06313684