Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Not Applicable

Recruiting

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

• Registration Number: NCT06313684
• Lead Sponsor: Universidad de La Frontera

Brief Summary

CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.

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 Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-09
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Hybrid Cardiac Rehabilitation	Continuous evaluation	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 Hybrid Cardiac Rehabilitation	Psychosocial support	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.
Exercise and center-based Cardiac Rehabilitation	Resistance exercise	Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
Exercise and center-based Cardiac Rehabilitation	Continuous exercise	Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
Comprehensive Hybrid Cardiac Rehabilitation	Comprehensive Initial Assessment	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 Hybrid Cardiac Rehabilitation	Diet management	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.
Exercise and center-based Cardiac Rehabilitation	Initial Assessment	Cardiac rehabilitation with face-to-face continuous aerobic exercise sessions and resistance exercises.
Comprehensive Hybrid Cardiac Rehabilitation	Interval Exercise	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 Hybrid Cardiac Rehabilitation	Resistance exercise	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.

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness	Baseline, 6 months and 12 months.	Will be assessed during a symptom-limited cardiopulmonary exercise test using an individualized gradual incremental ramp test designed to obtain oxygen consumption (VO2max).
Functional capacity	Baseline, 6 months and 12 months.	Will be assessed by the six-minute walk test (6MWT)
Health Related Quality of Life	Baseline, 6 months and 12 months.	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.

Secondary Outcome Measures

Name	Time	Method
Cost	6 months	Will be assessed through micro-costing from the health care system perspective. Also out-of-pocket spending by patients will be costed
Program adherence and completion	6 months	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.
Concentration of Pro-B-type Natriuretic Peptide	Baseline, 6 months and 12 months.	Biomarker with prognostic utility. When it is higher than 1000 pg/mL, there is a higher probability of having events such as hospitalizations.
Mortality and Hospital admission	12 months	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.
Lower-body muscle strength	Baseline, 6 months and 12 months.	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
Upper-body muscle strength	Baseline, 6 months and 12 months.	Will be assessed through grip strength performed with a Jamar® Plus+ electronic handheld dynamometer. the result shall be expressed in kilograms.
Functioning	Baseline, 6 months and 12 months.	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.

Trial Locations

Locations (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