CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
TR +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04821934
NCT04821934N/ACompleted

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

Istituti Clinici Scientifici Maugeri SpA·interventional·Posted Mar 30, 2021·Updated Oct 18, 2024

In Brief

A clinical study evaluating TR and TSu for COVID-19 Pneumonia. Completed, enrolled 74 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 30, 2021
Enrollment StartMar 26, 2021
Primary CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

TRother

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.

TSuother

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.