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| Name | Class |
|---|---|
| University of Chile | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Hybrid Cardiac Rehabilitation | Experimental | 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. |
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| Exercise and center-based Cardiac Rehabilitation | Active Comparator | Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Initial Assessment | Other | Initial Assessment includes all those necessary to prescribe exercise training, as well as dietary and adherence promotion interventions.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Concentration of Pro-B-type Natriuretic Peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisca Contreras | Contact | 56045 2325765 | mariafrancisca.contreras@ufrontera.cl |
| Name | Affiliation | Role |
|---|---|---|
| Pamela Seron, PhD | Universidad de La Frontera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario San José | Recruiting | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39610971 | Derived | 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. |
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Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Beginning 6 months following main results article publication.
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.
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| Continuous evaluation | Other | 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. |
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| Interval Exercise | Other | High-intensity interval training prescribed by physical therapist:
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| Psychosocial support | Behavioral | Based on social-cognitive theory, with self-efficacy as a focus:
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| Diet management | Other | A dietary plan supported by a nutritionist will be made together with the patient. |
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| Resistance exercise | Other | Resistance exercises:
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| Continuous exercise | Other | Moderate-intensity continuous exercise prescribed by physical therapist :
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| Initial Assessment | Other | Includes all those necessary to plan exercise training, as usual:
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Biomarker with prognostic utility. When it is higher than 1000 pg/mL, there is a higher probability of having events such as hospitalizations. |
| 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. | Baseline, 6 months and 12 months. |
| Mortality and Hospital admission | Will be measured as a composite outcome. It will be measured as a composite outcome. An adjudicating committee will confirm the events that will be expressed as the number of participants hospitalized or dead and their respective causes. All-cause and HF-specific mortality and hospitalization will be differentiated. | 12 months |
| Upper-body muscle strength | Will be assessed through grip strength performed with a Jamar® Plus+ electronic handheld dynamometer. the result shall be expressed in kilograms. | Baseline, 6 months and 12 months. |
| Lower-body muscle strength | Will be assessed through the chair stand test, with the participant in a seated position in a chair. From this position, they will be directed to rise fully and return to the starting position as many times as possible over 30 seconds. The number of repetitions achieved will be recorded | Baseline, 6 months and 12 months. |
| Cost | Will be assessed through micro-costing from the health care system perspective. Also out-of-pocket spending by patients will be costed | 6 months |
| Hospital Clínico Universidad de Chile | Recruiting | Santiago | Chile |
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| Hospital San Borja Arriarán | Recruiting | Santiago | Chile |
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| Universidad de La Frontera | Recruiting | Temuco | Chile |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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