NCT05865158

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.

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
60

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

May 9, 2023

Last Update Submit

November 7, 2023

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

  • Maximum inspiratory pressure by spirometry

    Value of the maximum inspiratory capacity in mm of H2O.

    6 weeks

  • Maximum expiratory pressure by spirometry

    Value of the maximum expiratory capacity in mm of H2O.

    6 weeks

  • 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

  • 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

Study Arms (2)

Institionalized group

EXPERIMENTAL

Group of institutionalized people with chronic cardiovascular diseases.

Other: Home-based exercises

Community-dwelling group

EXPERIMENTAL

Group of community-dwelling people with chronic cardiovascular diseases.

Other: Home-based exercises

Interventions

Home-based exercisesOTHER

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 groupInstitionalized group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatriz María Bermejo Gil

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Beatriz María Bermejo Gil

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz María Bermejo Gil, Dr

CONTACT

622289468beatriz.bermejo@usal.es

Fátima Pérez Robledo

CONTACT

622289468fatima_pr@usal.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor doctor

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

September 20, 2022

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)