SHCR-HF: The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Study Details
Study Description
Brief Summary
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:
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Is the novel cardiac rehabilitation model feasible for patients with HF?
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Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: smartphone-assisted hybrid cardiac rehabilitation (SHCR) 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)
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.
|
| No Intervention: Usual care Participants receive usual care including general education and exercise suggestion. |
Outcome Measures
Primary Outcome Measures
- Change of peak oxygen uptake [at baseline, 12 weeks(post-intervention), and 6 months.]
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.
- Change of 6 minute walking test [at baseline, 12 weeks(post-intervention), and 6 months.]
6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.
Secondary Outcome Measures
- Adherence to prescribed exercise [12 weeks(post-intervention)]
We will evaluate the percentage of completed prescribed exercises at 12 weeks.
- Evaluation of Quality of life [at baseline, 12 weeks(post-intervention), and 6 months.]
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
- Depression [at baseline, 12 weeks(post-intervention), and 6 months.]
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.
- Anxiety [at baseline, 12 weeks(post-intervention), and 6 months.]
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.
- Evaluation of physical activity [at baseline, 12 weeks(post-intervention), and 6 months.]
The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version.
- Evaluation of grip strength [at baseline, 12 weeks(post-intervention), and 6 months.]
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
- Evaluation of frailty [at baseline, 12 weeks(post-intervention), and 6 months.]
The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness.
- Blood test: Total cholesterol [at baseline, 12 weeks(post-intervention), and 6 months.]
The Total cholesterol will be tested in the laboratory.
- Blood test: LDL [at baseline, 12 weeks(post-intervention), and 6 months.]
The LDL will be tested in the laboratory.
- Blood test: HDL [at baseline, 12 weeks(post-intervention), and 6 months.]
The HDL will be tested in the laboratory.
- Blood test: Triglyceride [at baseline, 12 weeks(post-intervention), and 6 months.]
The Triglyceride will be tested in the laboratory.
- Blood test: NT-proBNP [at baseline, 12 weeks(post-intervention), and 6 months.]
The NT-proBNP will be tested in the laboratory.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with heart failure between the ages of 18 and 80 years old.
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NYHA (New York Heart Association) functional classification of 1 to 3.
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Patients must be in a stable condition and under outpatient follow-up.
Exclusion Criteria:
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Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
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Patients who are unable to complete cardiopulmonary exercise testing.
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Patients who are unable to follow verbal instructions.
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Patients who are unable to walk independently or pedal a stationary bicycle.
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Patients who are unable to use communication app on a smartphone.
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Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation.
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Patients who do not provide consent to participate in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202302009RINC