Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492551
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-07-04
Brief Title:
Post-COVID-19 Patients With Trak Tool
Sponsor:
Trak Health Solutions SL
Organization:
Trak Health Solutions SL
Study Overview
Official Title:
Prospective Clinical Trial of Trak Tool Usage in Post-COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAK-COVID
Brief Summary:
The clinical trial aims to analyse the effectiveness of a physiotherapeutic exercise program delivered through the telerehabilitation tool Trak compared to a booklet-based rehabilitation format in post-COVID-19 patients
This research seeks to provide insights into the acceptance of the TRAK tool in this specific population contributing to the advancement of understanding in this field
Participants will be assigned to either the control group which will receive conventional rehabilitation or the experimental group which will undergo telerehabilitation Both groups will undergo a 6-week physical intervention with pre- and post-intervention evaluations
Researchers will compare the control and experimental groups to determine if there are significant differences in the health conditions of each group
This research seeks to provide insights into the acceptance of the TRAK tool in this specific population contributing to the advancement of understanding in this field
Participants will be assigned to either the control group which will receive conventional rehabilitation or the experimental group which will undergo telerehabilitation Both groups will undergo a 6-week physical intervention with pre- and post-intervention evaluations
Researchers will compare the control and experimental groups to determine if there are significant differences in the health conditions of each group
Detailed Description:
The study recruitment process targets individuals who have experienced COVID-19 moderate or severe regardless of whether they required hospital admission and who necessitate rehabilitation post-disease and have been discharged from quarantine
After initial screening individuals meeting predefined inclusion criteria will be invited to participate Before enrollment written informed consent will be obtained from all participants to ensure ethical compliance and respect for individual autonomy
The primary evaluation variable selected for the study is functional capacity Additionally secondary assessments will include measurements of muscle strength subjective perception of exertion heart rate oxygen saturation lung capacity and adherence to treatment only in the experimental group
The study cohort will comprise patients randomly assigned to experimental or control groups
Only patients in the experimental group will receive an email containing access to the TRAK platform as part of the informed consent process Here they will conduct their treatment Initial and final assessments will be performed using a digital Case Report Form for the control and experimental groups
A rehabilitation doctor will determine the exercise protocol prescribed to the patient which physiotherapists will administer via TRAK experimental group or in-person format control group
Patients in the experimental group will use TRAK six weeks for rehabilitation following a prescribed exercise protocol prepared by a rehabilitation doctor Conversely individuals in the control group will adhere to instructions and guidelines provided by healthcare personnel during the same duration
The study will employ an intention-to-treat analysis approach incorporating all participants into the final analysis regardless of their adherence to the intervention protocol
After initial screening individuals meeting predefined inclusion criteria will be invited to participate Before enrollment written informed consent will be obtained from all participants to ensure ethical compliance and respect for individual autonomy
The primary evaluation variable selected for the study is functional capacity Additionally secondary assessments will include measurements of muscle strength subjective perception of exertion heart rate oxygen saturation lung capacity and adherence to treatment only in the experimental group
The study cohort will comprise patients randomly assigned to experimental or control groups
Only patients in the experimental group will receive an email containing access to the TRAK platform as part of the informed consent process Here they will conduct their treatment Initial and final assessments will be performed using a digital Case Report Form for the control and experimental groups
A rehabilitation doctor will determine the exercise protocol prescribed to the patient which physiotherapists will administer via TRAK experimental group or in-person format control group
Patients in the experimental group will use TRAK six weeks for rehabilitation following a prescribed exercise protocol prepared by a rehabilitation doctor Conversely individuals in the control group will adhere to instructions and guidelines provided by healthcare personnel during the same duration
The study will employ an intention-to-treat analysis approach incorporating all participants into the final analysis regardless of their adherence to the intervention protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None