Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- InCor Heart Institute
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Functional exercise capacity
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Martino Martinelli Filho
MD, PHD
InCor Heart Institute
Eligibility Criteria
Inclusion Criteria
- •Written informed consent prior to randomization and any study procedure;
- •Patients with any CIED
- •Access to the internet
- •Clinical stability in the last 3 weeks
- •With left ventricular ejection fraction (LVEF) greater than 40%
- •Skill to conduct the self-monitoring of intensity in physical activity
- •New York Heart Association classification 1 or 2
Exclusion Criteria
- •Unstable angina
- •Uncontrolled systemic arterial hypertension
- •Cardiac arrhythmia effort- induced
- •People with a musculoskeletal or neurological problem
- •Cognitive disability
- •Patients opposed to the participation in the research
- •Other concomitants cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
- •Moderate or severe chronic obstructive pulmonary disease;
Outcomes
Primary Outcomes
Functional exercise capacity
Time Frame: Six minutes
Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes
Secondary Outcomes
- Quality of life of patients(Thirty minutes)
- Anxiety and depression(Thirty minutes)
- Level of physical activity(Thirty minutes)