Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure (COCREATIONHF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III
• Intervention / Treatment: Other: Comprehensive Initial Assessment; Other: Continuous evaluation; Other: Interval Exercise; Behavioral: Psychosocial support; Other: Diet management; Other: Resistance exercise; Other: Continuous exercise; Other: Initial Assessment

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.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisca Contreras; Phone Number: 56045 2325765; Email: mariafrancisca.contreras@ufrontera.cl

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Hospital Clínico Universidad de Chile
    • Contact: Karen Rouliez
  • Santiago, Chile
    • Recruiting
    • Complejo Hospitalario San José
    • Contact: Manuel Galvez
  • Santiago, Chile
    • Recruiting
    • Hospital San Borja Arriarán
    • Contact: Gonzalo Latin
  • Temuco, Chile
    • Recruiting
    • Universidad de La Frontera
    • Contact: Francisca Contreras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other: 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.; Other: 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.; Behavioral: 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.; Other: Diet management; A dietary plan supported by a nutritionist will be made together with the patient.; Other: Resistance exercise; Resistance exercises: With TheraBand.; Intensity according to the perceived exertion scale; Twice a week.
Active Comparator: Exercise and center-based Cardiac Rehabilitation; Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.	Other: Resistance exercise; Resistance exercises: With TheraBand.; Intensity according to the perceived exertion scale; Twice a week.; Other: 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.; Other: Initial Assessment; Includes all those necessary to plan exercise training, as usual: Functional capacity with 6MWT.; Assessment of skeletal muscle strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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
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.	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.

Collaborators and Investigators

• Sponsor: Universidad de La Frontera
• Collaborators: University of Chile
• Investigators: Principal Investigator: Pamela Seron, PhD, Universidad de La Frontera

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: exercise; heart failure; cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Fondecyt 1230787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 6 months following main results article publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No