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| Name | Class |
|---|---|
| Spectator Healthcare Technology | UNKNOWN |
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Previous studies suggested that most patients with Cardiac Electronic Implantable devices have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. The MHOL-CEID is a randomized controlled trial that Verifies the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with Cardiac Electronic Implantable Device.
Cardiovascular diseases represent one of the main causes of death in the Brazilian population, as well as dysfunctions of the heart conduction system. In an attempt to treat and correct heart conduction system dysfunctions, Cardiac Electronic Implantable Device (CEID) was developed. Most people with CEID have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. These changes in the psychosocial conduct of patients with CEID are due to the lack of knowledge and the lack of effective guidance, being of fundamental importance to elaborate the resources of education in health for patients with CEID. Health promotion through educational intervention is a recognized strategy and an Internet approach to the mobile health proposal is a recognized and promising practice.
This randomized controlled study is been conducted to verify the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with CEID. The hypothesis is that the use of Mobile Health of lifestyle provides greater physical functional, psychological aspects, and quality of life to patients with CIED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (CG) | No Intervention | Control Group (CG): Standard of care, normally follow up, without mobile health | |
| Interventional Group (IG) | Experimental | Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health of lifestyle | Behavioral | Mobile health of lifestyle with an orientation about daily activities and necessary care to patients with CEID, and protocol of exercise training with images and guidelines to execute five days per week, with a duration of 50 minutes, and space for doubts which patients could send message to researcher. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional exercise capacity | Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes | Six minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patients | SF 36 questionnaire, evaluate health-related quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). | Thirty minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martino MM Martinelli Filho, PHD | InCor Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martino Martinelli Filho | São Paulo | São Paulo | 05403-900 | Brazil |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D057185 | Sedentary Behavior |
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise Control Group (CG): normally follow up, without mobile health
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| Anxiety and depression |
Hospital anxiety and depression scale, which consist 14 questions that evaluate how patients felt during the previous week. Scores with range 0-21. |
| Thirty minutes |
| Level of physical activity | IPAQ questionnaire, • To assesses the types of intensity of physical activity and sitting time that patients do on daily lives activities, and are considered to estimate total physical activity in MET-min/week and time spent sitting. | Thirty minutes |