NCT04582058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

4.5 years

First QC Date

October 4, 2020

Last Update Submit

August 24, 2021

Conditions

Cardiovascular DiseasesSedentary BehaviorAnxiety DisordersDepressive DisorderQuality of Life

Keywords

cardiovascular diseaseMobile Health

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Quality of life of patients

    Thirty minutes

  • Anxiety and depression

    Thirty minutes

  • Level of physical activity

    Thirty minutes

Study Arms (2)

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

Behavioral: Mobile Health of lifestyle

Interventions

Mobile Health of lifestyleBEHAVIORAL

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.

Interventional Group (IG)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martino Martinelli Filho

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary BehaviorAnxiety DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

BehaviorMental DisordersMood Disorders

Study Officials

  • Martino MM Martinelli Filho, PHD

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 9, 2020

Study Start

May 22, 2018

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

BR(1)