Tele-rehabilitation Program After Hospitalization for COVID-19

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Conditions

COVID-19 Pneumonia

Treatments

Other: TR

Other: TSu

Study type

Interventional

Funder types

Other

Identifiers

NCT04821934

ICS Maugeri 2514 CE

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

One or both the following points:
1. need for 24-hour oxygen therapy to have a resting SpO2 of at least 94% or exercise-induced desaturation, defined as a reduction of at least 3% of SpO2 mean measured during the 6-minute test (6MWT) compared to SpO2 measured at rest
2. reduced tolerance to effort highlighted by the 6MWT with a value of the meters travelled less than 70 percent of the predicted one

Exclusion criteria

Hemodynamic instability and the presence of uncontrolled cardiac arrhythmias
Any clinical condition that contraindicates aerobic exercise
Presence of motor disability before hospitalization which made it impossible to walk independently (Rankin scale> 3) (10)
Impaired cognitive status (Mini Mental State Examination test <24)
Inability to use (by the patient or a caregiver) the technological means sufficient to follow the program (mobile phone with internet connection)
Lack of supervision by a caregiver in case of walking and standing instability Contacts/Locations