Clinical trial NCT04582058: Mobile Health For Pacemaker Patientes
Official title: Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Sedentary Behavior
Anxiety Disorders
Depressive Disorder
Quality of Life
Keywords: cardiovascular disease
Mobile Health
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
Collaborators: name: Spectator Healthcare Technology
First posted: 2020-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Functional exercise capacity
timeFrame: Six minutes
Secondary outcomes:
measure: Quality of life of patients
timeFrame: Thirty minutes
measure: Anxiety and depression
timeFrame: Thirty minutes
measure: Level of physical activity
timeFrame: Thirty minutes
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Martino Martinelli Filho
state: Sao Paulo
Study officials:
affiliation: InCor Heart Institute
name: Martino MM Martinelli Filho, PHD
role: PRINCIPAL_INVESTIGATOR
References: