Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
NCT ID: NCT06313684
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2024-04-01
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Comprehensive Hybrid Cardiac Rehabilitation
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.
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.
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.
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.
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.
Diet management
A dietary plan supported by a nutritionist will be made together with the patient.
Resistance exercise
Resistance exercises:
* With TheraBand.
* Intensity according to the perceived exertion scale
* Twice a week.
Exercise and center-based Cardiac Rehabilitation
Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
Resistance exercise
Resistance exercises:
* With TheraBand.
* Intensity according to the perceived exertion scale
* Twice a week.
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.
Initial Assessment
Includes all those necessary to plan exercise training, as usual:
* Functional capacity with 6MWT.
* Assessment of skeletal muscle strength.
Interventions
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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.
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.
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.
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.
Diet management
A dietary plan supported by a nutritionist will be made together with the patient.
Resistance exercise
Resistance exercises:
* With TheraBand.
* Intensity according to the perceived exertion scale
* Twice a week.
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.
Initial Assessment
Includes all those necessary to plan exercise training, as usual:
* Functional capacity with 6MWT.
* Assessment of skeletal muscle strength.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Chile
OTHER
Universidad de La Frontera
OTHER
Responsible Party
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Pamela Serón
Principal Investigator
Principal Investigators
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Pamela Seron, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de La Frontera
Locations
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Complejo Hospitalario San José
Santiago, , Chile
Hospital Clínico Universidad de Chile
Santiago, , Chile
Hospital San Borja Arriarán
Santiago, , Chile
Universidad de La Frontera
Temuco, , Chile
Countries
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Central Contacts
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Facility Contacts
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Manuel Galvez
Role: primary
Karen Rouliez
Role: primary
Gonzalo Latin
Role: primary
Francisca Contreras
Role: primary
References
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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. eCollection 2024.
Other Identifiers
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Fondecyt 1230787
Identifier Type: -
Identifier Source: org_study_id