Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04368845
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2020-04-20
Brief Title:
Telerehabilitation in Patients With COVID-19 After Hospitalization The ATHLOS Study
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
A Telerehabilitation Approach to Improve Long-term Physical Ability and Quality of Life in Patients With Severe Acute Respiratory Syndrome Coronavirus SARSCoV-2 COVID-19 Immediately After Hospitalization The ATHLOS Study
Status:
COMPLETED
Status Verified Date:
2022-01
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:
ATHLOS
Brief Summary:
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals in order to offer telehealth services at home in patients with COVID-19 after hospital discharge
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms early fatigue muscle weakness eating difficulties etc
At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults aged 20-65 years diagnosed with COVID-19 who completed the first phase of this study At this phase the study will randomize 11 allocation 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care The intervention program includes individualized prescribed endurance exercises low intensity aerobic exercises upper and lower extremity strength training breathing exercises as well as a three times per month online support with 11 supervision via video conferencing with an expert physiotherapist
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms early fatigue muscle weakness eating difficulties etc
At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults aged 20-65 years diagnosed with COVID-19 who completed the first phase of this study At this phase the study will randomize 11 allocation 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care The intervention program includes individualized prescribed endurance exercises low intensity aerobic exercises upper and lower extremity strength training breathing exercises as well as a three times per month online support with 11 supervision via video conferencing with an expert physiotherapist
Detailed Description:
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals in order to offer home telehealth services in patients with COVID-19 after hospital discharge
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms early fatigue muscle weakness eating difficulties etc
We aim to support 200 patients with age 20-65 years between a 1-8 week period after hospital discharge providing an e-book with body exercises breathing exercises and nutritional support additionally to four telehealth consultation sessions
At the second phase a single blinded randomized control trial study will evaluate a 6-month home telerehabilitation program for 100 diagnosed with COVID-19 adults aged 20-65 years who completed the first phase of this study The second phase will randomize 11 allocation 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care
The intervention includes individualized prescribed upper and lower extremity endurance exercises aerobic exercises upper and lower extremity strength training breathing exercises as well as a three times per month online support with 11 supervision via video conferencing with an expert physiotherapist
The usual care group will be advised to follow the instructions of the e-book for any possible exercise training Three times per month with 11 video conferencing an expert physiotherapist will record any possible exercise with no further recommendations or support
Changes from baseline in physical activity levels cardiorespiratory fitness physical performance lower limb strength anxiety and depression and health-related quality of life will be assessed at 3 and 6 months for both groups All functional tests in the second phase of the study will be performed via supervision teleconference for all the participants with an expert physiotherapist Findings from this project will contribute to the field of telerehabilitation in patients with COVID-19 after hospital discharge and will provide critical preliminary data for the design and implementation of a larger randomized control trial assessing the impact of telerehabilitation on long-term clinical outcomes following infection or re-infection from coronaviruses
At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms early fatigue muscle weakness eating difficulties etc
We aim to support 200 patients with age 20-65 years between a 1-8 week period after hospital discharge providing an e-book with body exercises breathing exercises and nutritional support additionally to four telehealth consultation sessions
At the second phase a single blinded randomized control trial study will evaluate a 6-month home telerehabilitation program for 100 diagnosed with COVID-19 adults aged 20-65 years who completed the first phase of this study The second phase will randomize 11 allocation 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care
The intervention includes individualized prescribed upper and lower extremity endurance exercises aerobic exercises upper and lower extremity strength training breathing exercises as well as a three times per month online support with 11 supervision via video conferencing with an expert physiotherapist
The usual care group will be advised to follow the instructions of the e-book for any possible exercise training Three times per month with 11 video conferencing an expert physiotherapist will record any possible exercise with no further recommendations or support
Changes from baseline in physical activity levels cardiorespiratory fitness physical performance lower limb strength anxiety and depression and health-related quality of life will be assessed at 3 and 6 months for both groups All functional tests in the second phase of the study will be performed via supervision teleconference for all the participants with an expert physiotherapist Findings from this project will contribute to the field of telerehabilitation in patients with COVID-19 after hospital discharge and will provide critical preliminary data for the design and implementation of a larger randomized control trial assessing the impact of telerehabilitation on long-term clinical outcomes following infection or re-infection from coronaviruses
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