Cardiovascular DiseasesCardioSafe+NCT05865158
CardioSafe+: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems
A study testing Home-based exercises in people with Cardiovascular Diseases, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Home-based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2022to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Beatriz María Bermejo Gil
Salamanca, 37007
Beatriz María Bermejo Gil, Dr., 622289468, beatriz.bermejo@usal.es
Fátima Perez Robledo, 619885479, fatima_pr@usal.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Home-based exercises
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Institionalized group | Experimental | Group of institutionalized people with chronic cardiovascular diseases. Receives: Other: Home-based exercises |
| Community-dwelling group | Experimental | Group of community-dwelling people with chronic cardiovascular diseases. Receives: Other: Home-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure by spirometry
Value of the maximum inspiratory capacity in mm of H2O.
Measured: 6 weeks
Maximum expiratory pressure by spirometry
Value of the maximum expiratory capacity in mm of H2O.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start20 Sep 2022
- Primary completion22 Jun 2024 (estimated)
- Study completion22 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz-María Bermejo-Gil, University of Salamanca
- Investigators
- Beatriz María Bermejo Gil, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865158
- Sponsor's protocol ID
- CardioSafe+
- Acronym
- CardioSafe+
- Status last verified
- Nov 2023
- First submitted
- 9 May 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioSafe Plus: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems.
- ClinicalTrials.gov ID
- NCT05865158
- Acronym / sponsor ID
- CardioSafe+ / CardioSafe+
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 22 Jun 2024 (estimated)
- Study completion
- 22 Jun 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Institionalized group | Experimental | Other: Home-based exercisesGroup of institutionalized people with chronic cardiovascular diseases. |
| Community-dwelling group | Experimental | Other: Home-based exercisesGroup of community-dwelling people with chronic cardiovascular diseases. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercisesHome-based exercises proposed through the CardioSafe+ platform, guided by therapists specialized in cardiovascular disorders, who will try to adapt the sessions to each participant. | Other | Community-dwelling group, Institionalized group |
Primary outcome
Maximum inspiratory pressure by spirometry
Time frame: 6 weeks
Value of the maximum inspiratory capacity in mm of H2O.
Maximum expiratory pressure by spirometry
Time frame: 6 weeks
Value of the maximum expiratory capacity in mm of H2O.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz María Bermejo Gil principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercises in people with Cardiovascular Diseases, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz María Bermejo Gil, Dr (622289468, beatriz.bermejo@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure by spirometry (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.