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

Cardiovascular Diseases Clinical Trial

— CardioSafe+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865158
• Other study ID #: CardioSafe+
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: June 22, 2024

Study information

• Verified date: November 2023
• Source: University of Salamanca
• Contact: Beatriz María Bermejo Gil, Dr
• Phone: 622289468
• Email: beatriz.bermejo[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 22, 2024
• Est. primary completion date: June 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Beatriz María Bermejo Gil	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum inspiratory pressure by spirometry	Value of the maximum inspiratory capacity in mm of H2O.	6 weeks
Primary	Maximum expiratory pressure by spirometry	Value of the maximum expiratory capacity in mm of H2O.	6 weeks
Primary	Borg Rating of Perceived Exertion Scale	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
Primary	2 minute stationary walk test	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