The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions: Is the novel cardiac rehabilitation model feasible for patients with HF? Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?

Official Title
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The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: smartphone-assisted hybrid cardiac rehabilitation (SHCR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart failure between the ages of 18 and 80 years old. NYHA (New York Heart Association) functional classification of 1 to 3. Patients must be in a stable condition and under outpatient follow-up. Exclusion Criteria: Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Patients who are unable to complete cardiopulmonary exercise testing. Patients who are unable to follow verbal instructions. Patients who are unable to walk independently or pedal a stationary bicycle. Patients who are unable to use communication app on a smartphone. Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation. Patients who do not provide consent to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smartphone-assisted hybrid cardiac rehabilitation (SHCR)<br>Participants receive a 12-wk case manager-led smartphone-assisted hybrid cardiac rehabilitation with follow-up at 12 week and 6 months. | Other: smartphone-assisted hybrid cardiac rehabilitation (SHCR)<br>* The 12-week case manager-led SHCR program includes: Customized exercise prescriptions following ACSM's heart failure guidelines. A hybrid program combining in-person sessions, home self-exercise, and videoconferencing for exercise coaching(optional), supported by a smartphone app. Case managers instruct patients on a communication app for weekly follow-ups, health education messages, exercise reminders, and progress tracking, including metrics like blood pressure, heart rate, weight, and symptoms.<br>|
| No Intervention: Usual care<br>Participants receive usual care including general education and exercise suggestion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of peak oxygen uptake | Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Change of 6 minute walking test | 6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months. | at baseline, 12 weeks(post-intervention), and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to prescribed exercise | We will evaluate the percentage of completed prescribed exercises at 12 weeks. | 12 weeks(post-intervention) | 
| Evaluation of Quality of life | The investigators will assess the change in 36-Item Short Form Survey(SF-36). | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Depression | The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Anxiety | The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Evaluation of physical activity | The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Evaluation of grip strength | The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Evaluation of frailty | The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Blood test: Total cholesterol | The Total cholesterol will be tested in the laboratory. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Blood test: LDL | The LDL will be tested in the laboratory. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Blood test: HDL | The HDL will be tested in the laboratory. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Blood test: Triglyceride | The Triglyceride will be tested in the laboratory. | at baseline, 12 weeks(post-intervention), and 6 months. | 
| Blood test: NT-proBNP | The NT-proBNP will be tested in the laboratory. | at baseline, 12 weeks(post-intervention), and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, heart failure, eHealth