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The goal of this randomized controlled trial is to compare the effect of eHealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.
Cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. International guidelines list cardiac rehabilitation after myocardial infarction as class IA recommendation. However, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide.
eHealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. Thus, we design a randomized controlled trial to compare the effect of a case manager-led eHealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth-based cardiac rehabilitation | Experimental | Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months. |
|
| Usual care | No Intervention | Participants receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth-based cardiac rehabilitation | Other | The 12-wk case manager-led eHCR 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 12 months. | at baseline, 12 weeks(post-intervention), and 12 months. |
| Change of ventilatory anaerobic threshold | Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months. | at baseline, 12 weeks(post-intervention), and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to prescribed exercise | The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months. | at 12 weeks(post-intervention) and 12 months. |
| Evaluation of Quality of life |
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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 | 103311@ntuh.gov.tw |
| 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 |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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The investigators will assess the change in 36-Item Short Form Survey(SF-36).
| at baseline, 12 weeks(post-intervention), and 12 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 12 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 12 months. |
| Evaluation of physical activity | The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version. | at baseline, 12 weeks(post-intervention), and 12 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 12 months. |
| Evaluation of isometric knee extension strength | The isometric knee extension strength will be measured using a dynamometer with participants seated and knee flexed at 90 degrees. | at baseline, 12 weeks(post-intervention), and 12 months. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |