Back to resultsRespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Breathing exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring respiration disorders, telerehabilitation, breathing exercises, complications
Eligibility Criteria
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.
Sites / Locations
- Ines Llamas-Ramos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single group
Arm Description
Implementation of a mobile application for the rehabilitation of patients with respiratory sequelae of COVID-19
Outcomes
Primary Outcome Measures
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.
Level of satisfaction and acceptability.
A Likert-type scale will be used. 1-Not Satisfied to 5-Extremely satisfied.
St. George's Respiratory Questionnaire, SGRQ
scale from 0-100 points.Where higher scores mean worse outcomes.
Secondary Outcome Measures
Age
The date of birth will be registered in order to calculate the age of the participant.
Sex
Participant's sex will be registered
Diagnosis of respiratory pathology
Participant's diagnosis will be registered.
Full Information
NCT ID
NCT04703478
First Posted
January 4, 2021
Last Updated
January 8, 2021
Sponsor
University of Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT04703478
Brief Title
RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Anticipated)
Primary Completion Date
April 20, 2021 (Anticipated)
Study Completion Date
April 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
respiration disorders, telerehabilitation, breathing exercises, complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single group
Arm Type
Experimental
Arm Description
Implementation of a mobile application for the rehabilitation of patients with respiratory sequelae of COVID-19
Intervention Type
Other
Intervention Name(s)
Breathing exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rating of perceived exertion (Borg Scale)
Description
Scale from 1-10 points. Where number 1 means very light activity and 10, represents an extreme intensity of activity.
Time Frame
10 minutes.
Title
Level of satisfaction and acceptability.
Description
A Likert-type scale will be used. 1-Not Satisfied to 5-Extremely satisfied.
Time Frame
20 minutes.
Title
St. George's Respiratory Questionnaire, SGRQ
Description
scale from 0-100 points.Where higher scores mean worse outcomes.
Time Frame
40 minutes.
Secondary Outcome Measure Information:
Title
Age
Description
The date of birth will be registered in order to calculate the age of the participant.
Time Frame
2 minutes.
Title
Sex
Description
Participant's sex will be registered
Time Frame
2 minutes.
Title
Diagnosis of respiratory pathology
Description
Participant's diagnosis will be registered.
Time Frame
2 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz M Bermejo-Gil, Prof.
Phone
+34 622 289 468
Email
beatriz.bermejo@usal.es
First Name & Middle Initial & Last Name or Official Title & Degree
Rocio Llamas-Ramos, Dr.
Phone
+34 657 854 188
Email
rociollamas@usal.es
Facility Information:
Facility Name
Ines Llamas-Ramos
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Llamas-Ramos, Dr.
Phone
+34 663 008736
Email
inesllamas@usal.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
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