Clinical trial NCT05865158: CardioSafe+: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems
Official title: CardioSafe Plus: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum inspiratory pressure by spirometry
timeFrame: 6 weeks
measure: Maximum expiratory pressure by spirometry
timeFrame: 6 weeks
measure: Borg Rating of Perceived Exertion Scale
timeFrame: 6 weeks
measure: 2 minute stationary walk test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Beatriz María Bermejo Gil
Study officials:
affiliation: University of Salamanca
name: Beatriz María Bermejo Gil
role: PRINCIPAL_INVESTIGATOR
References: