Covid19NCT04703478
RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
A study testing Breathing exercise in people with Covid19, run by University of Salamanca at 1 site in Spain.
Trial summary
Platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. It also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2021to 20 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Respiratory affectation diagnosis
- Internet access to run the application
Who cannot join
- Presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Ines Llamas-Ramos
Salamanca, 37007
Ines Llamas-Ramos, Dr., +34 663 008736, inesllamas@usal.es
About this study
Official title: RespiraConNosotros: Creation and Implementation of a Mobile Application for the Rehabilitation of Patients With Respiratory Sequelae of the SARS-CoV-2 (COVID-19)
Platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. It also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts.
Currently, the application is ready for use, the registration of users and professionals is enabled and have 20 exercises divided into three intensity levels.
Read more
It is available for all platforms (PC, ANDROID, iOS). presents a simple deployment, accessible to the entire population and does not require installation.
In the future, investigators will include more languages, a greater variety of exercises and even other types of therapies. Investigators will also carry out the adaptation to functional diversity with subtitles and voice commands.
- Conditions
- Covid19
- Being tested
- Breathing exercise
- Keywords
- respiration disorders, telerehabilitation, breathing exercises, complications
- Medical subject headings
- COVID-19, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
Participants will carry out a breathing exercise program through the RespiraConNosotros mobile application. They will be asked to carry out the proposed exercises with a frequency of 3 times a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Implementation of a mobile application for the rehabilitation of patients with respiratory sequelae of COVID-19 Receives: Other: Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of perceived exertion (Borg Scale)
Scale from 1-10 points. Where number 1 means very light activity and 10, represents an extreme intensity of activity.
Measured: 10 minutes.
Level of satisfaction and acceptability.
A Likert-type scale will be used. 1-Not Satisfied to 5-Extremely satisfied.
Measured: 20 minutes.
St. George's Respiratory Questionnaire, SGRQ
scale from 0-100 points.Where higher scores mean worse outcomes.
Measured: 40 minutes.
Secondary outcomes (3)
Age
The date of birth will be registered in order to calculate the age of the participant.
Measured: 2 minutes.
Sex
Participant's sex will be registered
Measured: 2 minutes.
Diagnosis of respiratory pathology
Participant's diagnosis will be registered.
Measured: 2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start20 Jan 2021 (estimated)
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703478
- Sponsor's protocol ID
- CovidSal02
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RespiraConNosotros: Creation and Implementation of a Mobile Application for the Rehabilitation of Patients With Respiratory Sequelae of the SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04703478
- Acronym / sponsor ID
- CovidSal02
- Conditions
- Covid19
- Keywords
- respiration disorders, telerehabilitation, breathing exercises, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 20 Jan 2021 (estimated)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Apr 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. It also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts.
Currently, the application is ready for use, the registration of users and professionals is enabled and have 20 exercises divided into three intensity levels.
It is available for all platforms (PC, ANDROID, iOS). presents a simple deployment, accessible to the entire population and does not require installation.
In the future, investigators will include more languages, a greater variety of exercises and even other types of therapies. Investigators will also carry out the adaptation to functional diversity with subtitles and voice commands.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Other: Breathing exerciseImplementation of a mobile application for the rehabilitation of patients with respiratory sequelae of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Respiratory affectation diagnosis
- Internet access to run the application
Key exclusion criteria (1 listed)
- Presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.
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 |
|---|---|---|
| Breathing exerciseParticipants will carry out a breathing exercise program through the RespiraConNosotros mobile application. They will be asked to carry out the proposed exercises with a frequency of 3 times a week for 3 months. | Other | Single group |
Primary outcome
Rating of perceived exertion (Borg Scale)
Time frame: 10 minutes.
Scale from 1-10 points. Where number 1 means very light activity and 10, represents an extreme intensity of activity.
Level of satisfaction and acceptability.
Time frame: 20 minutes.
A Likert-type scale will be used. 1-Not Satisfied to 5-Extremely satisfied.
St. George's Respiratory Questionnaire, SGRQ
Time frame: 40 minutes.
scale from 0-100 points.Where higher scores mean worse outcomes.
3 secondary outcomes
Age
Time frame: 2 minutes.
Sex
Time frame: 2 minutes.
Diagnosis of respiratory pathology
Time frame: 2 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Covid19, 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 2 inclusion and 1 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 12 Jan 2021. 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 M Bermejo-Gil, Prof. (+34 622 289 468, beatriz.bermejo@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating of perceived exertion (Borg Scale) (time frame: 10 minutes.). The study lists 3 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 12 Jan 2021.