NCT04821934

Tele-rehabilitation Program After Hospitalization for COVID-19

Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
OTHER	TR	TR is a specific remote tele rehabilitation program on exercise activity managed by the physiotherapist (PT) at home, this is the experimental group. PT will explain the rehabilitation program at hospital discharge by the use of a brochure and videos. TR will include an early exercise re-conditioning program \[aerobic exercise at the free body (with or without tools), cyclette and walking with a pedometer\] comprising 20 sessions of 60 minutes/day, 6 out of 7 days to be performed at home, for one month after discharge. The sessions will be self-managed by the patients 4 times a week and an expert PT will remotely supervise 2 times a week through a dedicated platform. The program will be progressively incremental and divided into 4 different levels of intensity (0- 3). In addition to this specific rehabilitation program, the patients will be followed by a nurse tutor once a day for two weeks and once a week for a further two weeks in a program of Telesurveillance.
OTHER	TSu	The patients of this group will perform a usual Telesurveillance and will be considered as control group. All patients, at discharge from the hospital, will be provided with a finger pulse oximeter and a dedicated application (app) on their personal smartphone and will be advised on free physical activity to be performed at home. The nurse will check through scheduled calls (once a day for two weeks and once a week for a further two weeks) the patient's health condition, vital parameters and drugs administration. Patients will be able to contact the nurse at each time, in case of specific need, out of the scheduled call, 7/7 days. A follow up by phone will be planned by nurse tutor at 2 months from the end of the study.

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-03-30
• Last updated: 2024-10-18

Locations

2 sites across 1 country: Italy