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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smartphone-assisted hybrid cardiac rehabilitation (SHCR) | Experimental | Participants receive a 12-wk case manager-led smartphone-assisted hybrid cardiac rehabilitation with follow-up at 12 week and 6 months. |
|
| Usual care | No Intervention | Participants receive usual care including general education and exercise suggestion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartphone-assisted hybrid cardiac rehabilitation (SHCR) | Other | The 12-week case manager-led SHCR program includes:
|
| 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. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hung-Jui Chuang, MD | Contact | 00886-2-23123456 | 67034 | rexintwo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hung-Jui Chuang, MD | Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |