- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04703478
RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
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.
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Salamanca, Spain, 37007
- Ines Llamas-Ramos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Respiratory affectation diagnosis
- Internet access to run the application
Exclusion Criteria:
- Presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single group
Implementation of a mobile application for the rehabilitation of patients with respiratory sequelae of COVID-19
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes.
|
|
Level of satisfaction and acceptability.
Time Frame: 20 minutes.
|
A Likert-type scale will be used.
1-Not Satisfied to 5-Extremely satisfied.
|
20 minutes.
|
|
St. George's Respiratory Questionnaire, SGRQ
Time Frame: 40 minutes.
|
scale from 0-100 points.Where higher scores mean worse outcomes.
|
40 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 2 minutes.
|
The date of birth will be registered in order to calculate the age of the participant.
|
2 minutes.
|
|
Sex
Time Frame: 2 minutes.
|
Participant's sex will be registered
|
2 minutes.
|
|
Diagnosis of respiratory pathology
Time Frame: 2 minutes.
|
Participant's diagnosis will be registered.
|
2 minutes.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CovidSal02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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