Mobile Health For Pacemaker Patientes

Not Applicable

• Conditions: Sedentary Behavior; Anxiety Disorders; Depressive Disorder; Quality of Life; Cardiovascular Diseases
• Interventions: Behavioral: Mobile Health of lifestyle

• Registration Number: NCT04582058
• Lead Sponsor: InCor Heart Institute

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.

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-11-20
• Study Completion: 2022-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group (IG)	Mobile Health of lifestyle	Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise

Primary Outcome Measures

Name	Time	Method
Functional exercise capacity	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 Outcome Measures

Name	Time	Method
Quality of life of patients	Thirty minutes	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).
Anxiety and depression	Thirty minutes	Hospital anxiety and depression scale, which consist 14 questions that evaluate how patients felt during the previous week. Scores with range 0-21.
Level of physical activity	Thirty minutes	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.

Trial Locations

Locations (1)

Martino Martinelli Filho; 🇧🇷 São Paulo, Sao Paulo, Brazil