Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
COCREATIONHF
1 other identifier
interventional
152
1 country
4
Brief Summary
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 3, 2024
November 1, 2024
2.4 years
March 4, 2024
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
Baseline, 6 months and 12 months.
Functional capacity
Will be assessed by the six-minute walk test (6MWT)
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.
Baseline, 6 months and 12 months.
Secondary Outcomes (7)
Program adherence and completion
6 months
Concentration of Pro-B-type Natriuretic Peptide
Baseline, 6 months and 12 months.
Functioning
Baseline, 6 months and 12 months.
Mortality and Hospital admission
12 months
Upper-body muscle strength
Baseline, 6 months and 12 months.
- +2 more secondary outcomes
Study Arms (2)
Comprehensive Hybrid Cardiac Rehabilitation
EXPERIMENTALThe 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.
Exercise and center-based Cardiac Rehabilitation
ACTIVE COMPARATORCardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de La Fronteralead
- University of Chilecollaborator
Study Sites (4)
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
Related Publications (1)
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.
PMID: 39610971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Seron, PhD
Universidad de La Frontera
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 15, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months following main results article publication.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee. For individual participant data meta-analysis. Proposals should be directed to Principal Investigator. To gain access, data requestors will need to sign a data access agreement.
Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).