The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
- Conditions
- Heart Failure
- Interventions
- Other: smartphone-assisted hybrid cardiac rehabilitation (SHCR)
- Registration Number
- NCT05873543
- Lead Sponsor
- National Taiwan University Hospital
- 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:
1. Is the novel cardiac rehabilitation model feasible for patients with HF?
2. Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description smartphone-assisted hybrid cardiac rehabilitation (SHCR) 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Adherence to prescribed exercise 12 weeks(post-intervention) We will evaluate the percentage of completed prescribed exercises at 12 weeks.
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.
Blood test: Triglyceride at baseline, 12 weeks(post-intervention), and 6 months. The Triglyceride will be tested in the laboratory.
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).
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.
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 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.
Blood test: HDL at baseline, 12 weeks(post-intervention), and 6 months. The HDL will be tested in the laboratory.
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: NT-proBNP at baseline, 12 weeks(post-intervention), and 6 months. The NT-proBNP will be tested in the laboratory.
Trial Locations
- Locations (1)
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
🇨🇳Taipei, Taiwan