CardioSafe+: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems (CardioSafe+)

November 7, 2023 updated by: Beatriz-María Bermejo-Gil, University of Salamanca

CardioSafe Plus: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems.

The use of telerehabilitation seems to be effective in managing complications after suffering a cardiovascular pathology. The use of the CardioSafe+ digital platform is suggested for the management of these complications. For this reason, an intervention will be carried out to determine the effectiveness of this platform. A total of 60 participants will be recruited to carry out a home-exercise intervention through CardioSafe+ for 6 weeks. Maximun respiratory pressures, exertion capacity, and subjective sensation of exertion will be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This intervention seeks to determine the effectiveness of the CardioSafe+ digital platform in aiding individuals recovering from cardiovascular pathologies. By involving a group of 60 participants in a structured six-week home-exercise program using the CardioSafe+ platform, the objective is to measure and evaluate various factors related to their physical well-being and recovery.

Key components to be evaluated include:

Maximal Respiratory Pressures: This involves measuring the maximum force generated during inspiration and expiration, which can indicate respiratory muscle strength and function.

Exertion Capacity: The assessment aims to gauge the participants' ability to engage in physical activities, potentially reflecting improvements in overall cardiovascular fitness and endurance.

Subjective Sensation of Exertion: This component involves understanding how the participants perceive and rate their own exertion during exercises, contributing to insights about their subjective experience and effort perception.

The intervention's objective is to collect data on these parameters before and after the six-week exercise program utilizing the CardioSafe+ digital platform. This data will help determine the effectiveness of the platform in aiding individuals recovering from cardiovascular pathologies and could provide valuable insights for further implementing tele-rehabilitation in managing such health complications.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Recruiting
        • Beatriz María Bermejo Gil
        • Contact:
        • Contact:
        • Principal Investigator:
          • Beatriz María Bermejo Gil, Dr
        • Principal Investigator:
          • Fátima Pérez Robledo, Dr
        • Principal Investigator:
          • Luis Augusto Silva, Dr
        • Sub-Investigator:
          • Andre Sales Mendes, Dr
        • Sub-Investigator:
          • Anita Maria Rocha Fernandez, Dr
        • Sub-Investigator:
          • Hector Sanchez San Blas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • People who present a cardiovascular pathology with more than one year of evolution.
  • To be in a stable medical situation.
  • To have access to technological resources and knowledge for their use.

Exclusion Criteria:

  • People who present any contraindication established for carrying out physical activity.
  • People who present insufficient capacity to understand and obey the instructions offered by the researchers, both in the evaluation and in the intervention.
  • People who have a cardiac pathology with obvious fluctuations in the course of the disease.
  • The presence of an acute episode of the disease during the intervention period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Institionalized group
Group of institutionalized people with chronic cardiovascular diseases.
Other: Home-based exercises
Home-based exercises proposed through the CardioSafe+ platform, guided by therapists specialized in cardiovascular disorders, who will try to adapt the sessions to each participant.
Experimental: Community-dwelling group
Group of community-dwelling people with chronic cardiovascular diseases.
Other: Home-based exercises
Home-based exercises proposed through the CardioSafe+ platform, guided by therapists specialized in cardiovascular disorders, who will try to adapt the sessions to each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 minute stationary walk test
Time Frame: 6 weeks
Effort test in which the participant is asked to lift their knees for 2 minutes and the number of times is counted. Based on that number, the percentile in which the person is based on their age and sex is calculated.
6 weeks
Maximum inspiratory pressure by spirometry
Time Frame: 6 weeks
Value of the maximum inspiratory capacity in mm of H2O.
6 weeks
Maximum expiratory pressure by spirometry
Time Frame: 6 weeks
Value of the maximum expiratory capacity in mm of H2O.
6 weeks
Borg Rating of Perceived Exertion Scale
Time Frame: 6 weeks
Scale of perceived subjective effort in which it is valued with a score of 0 to 10, subjectively. Started from 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Investigators

  • Principal Investigator: Beatriz María Bermejo Gil, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Estimated)

June 22, 2024

Study Completion (Estimated)

June 22, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CardioSafe+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Los datos de los participantes se trataran segun la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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