Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT04821934
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-rehabilitation Program After Hospitalization for COVID-19
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Study Overview
Official Title:
Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option.
The aim of our study will be to investigate the effectiveness of a structured telerehabilitation program with a specific rehabilitation intervention on exercise tolerance at home in the subject discharged after hospitalization for COVID-19 pneumonia, in comparison to a traditional remote monitoring program (without any rehabilitation intervention).
Other secondary objectives will be the evaluation of safety, feasibility, clinical impact on symptom status (asthenia, dyspnea), gas exchange (day, night and under exertion), lung function, muscle strength, functional capacity and quality of life.
The aim of our study will be to investigate the effectiveness of a structured telerehabilitation program with a specific rehabilitation intervention on exercise tolerance at home in the subject discharged after hospitalization for COVID-19 pneumonia, in comparison to a traditional remote monitoring program (without any rehabilitation intervention).
Other secondary objectives will be the evaluation of safety, feasibility, clinical impact on symptom status (asthenia, dyspnea), gas exchange (day, night and under exertion), lung function, muscle strength, functional capacity and quality of life.
Detailed Description:
The rapid spread of Covid-19 has produced a large number of hospitalized patients, even for relatively long problems and with the need for intensive or sub-intensive care.
Upon discharge from the hospital, some studies have shown that the majority of subjects with COVID-19 present a reduction in functional capacity, exercise tolerance and muscle strength, regardless of previous health status and pre-existing disabilities. Furthermore, some works on patients suffering from similar respiratory infections, such as SARS or MERS, have described how a functional deficit can persist even in the long term. An early rehabilitation intervention, which included aerobic reconditioning, was tested in some pilot observational studies in hospitalized subjects for COVID-19, and proved feasible and safe. A single randomized controlled Chinese study has documented the efficacy of an acute respiratory rehabilitation intervention. Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option. Telerehabilitation programs that included effort re-conditioning, intended for subjects with reduced functional capacity, have already been successfully proposed in cardiac, respiratory, orthopedic, and neurological patients. No studies until now have described the feasibility, safety and efficacy of early exercise reconditioning treatment to improve disability in the subject discharged after hospitalization for COVID-19 pneumonia.
Upon discharge from the hospital, some studies have shown that the majority of subjects with COVID-19 present a reduction in functional capacity, exercise tolerance and muscle strength, regardless of previous health status and pre-existing disabilities. Furthermore, some works on patients suffering from similar respiratory infections, such as SARS or MERS, have described how a functional deficit can persist even in the long term. An early rehabilitation intervention, which included aerobic reconditioning, was tested in some pilot observational studies in hospitalized subjects for COVID-19, and proved feasible and safe. A single randomized controlled Chinese study has documented the efficacy of an acute respiratory rehabilitation intervention. Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option. Telerehabilitation programs that included effort re-conditioning, intended for subjects with reduced functional capacity, have already been successfully proposed in cardiac, respiratory, orthopedic, and neurological patients. No studies until now have described the feasibility, safety and efficacy of early exercise reconditioning treatment to improve disability in the subject discharged after hospitalization for COVID-19 pneumonia.
Study Oversight
Has Oversight DMC:
False
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?: