Heart Failure NYHA Class IICOCREATIONHFNCT06313684
Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
A study testing Comprehensive Initial Assessment, Continuous evaluation and Interval Exercise in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Universidad de La Frontera at 4 sites in Chile.
Trial summary
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- Comprehensive Initial Assessment, Continuous evaluation and Interval Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 4 sitesChile
- Study dates
- 1 Apr 2024to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patient consents to participate in the study by signing an informed consent form.
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile4 sites, 4 recruiting
- Recruiting
Complejo Hospitalario San José
Santiago
Manuel Galvez
- Recruiting
Hospital Clínico Universidad de Chile
Santiago
Karen Rouliez
- Recruiting
Hospital San Borja Arriarán
Santiago
Gonzalo Latin
- Recruiting
Universidad de La Frontera
Temuco
Francisca Contreras
About this study
Official title: Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Read the detailed description
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.
- Being tested
- Comprehensive Initial Assessment, Continuous evaluation, Interval Exercise, Psychosocial support, Diet management
- Keywords
- cardiac rehabilitation, heart failure, exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Psychosocial supportBehavioural
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 managementOther
A dietary plan supported by a nutritionist will be made together with the patient.
Resistance exerciseOther
Resistance exercises:
- With TheraBand.
- Intensity according to the perceived exertion scale
- Twice a week.
Continuous exerciseOther
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 AssessmentOther
Includes all those necessary to plan exercise training, as usual:
- Functional capacity with 6MWT.
- Assessment of skeletal muscle strength.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Comprehensive Initial Assessment; Other: Continuous evaluation; Other: Interval Exercise; Behavioral: Psychosocial support; Other: Diet management; Other: Resistance exercise |
| Exercise and center-based Cardiac Rehabilitation | Active comparator | Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises. Receives: Other: Resistance exercise; Other: Continuous exercise; Other: Initial Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 months and 12 months.
Functional capacity
Will be assessed by the six-minute walk test (6MWT)
Measured: 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.
Measured: Baseline, 6 months and 12 months.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Principal investigator, Pamela Serón, Universidad de La Frontera
- Investigators
- Pamela Seron, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313684
- Sponsor's protocol ID
- Fondecyt 1230787
- Acronym
- COCREATIONHF
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 39610971