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

NCT ID: NCT05865158

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2024-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Institionalized group

Group of institutionalized people with chronic cardiovascular diseases.

Group Type EXPERIMENTAL

Home-based exercises

Intervention Type OTHER

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.

Community-dwelling group

Group of community-dwelling people with chronic cardiovascular diseases.

Group Type EXPERIMENTAL

Home-based exercises

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Beatriz-María Bermejo-Gil

Assistant professor doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beatriz María Bermejo Gil

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beatriz María Bermejo Gil

Salamanca, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Beatriz María Bermejo Gil, Dr

Role: CONTACT

622289468

Fátima Pérez Robledo

Role: CONTACT

622289468

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Beatriz María Bermejo Gil, Dr.

Role: primary

622289468

Fátima Perez Robledo

Role: backup

619885479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CardioSafe+

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Heart at Home- a Self-care Study
NCT01759368 COMPLETED NA
The SMArTVIEW, CoVeRed
NCT03253549 COMPLETED NA