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Clinical Trials/NCT05739552
NCT05739552
Completed
N/A

Telerehabilitation in the Post-COVID-19 Patient: the Italy-Switzerland Experience

Istituto Auxologico Italiano2 sites in 2 countries30 target enrollmentJuly 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-COVID-19 Syndrome
Sponsor
Istituto Auxologico Italiano
Enrollment
30
Locations
2
Primary Endpoint
Change from baseline balance and functional mobility.
Status
Completed
Last Updated
last year

Overview

Brief Summary

A major issue brought about by the current pandemic concerns the discontinuation of a large proportion of outpatient services provided locally, especially in the rehabilitation field. Added to this situation is the ever-increasing demand for rehabilitation for post-COronaVIrus Disease 19 (COVID-19) patients. Data show that respiratory and motor rehabilitation for people infected with COVID-19 is necessary at all stages of the disease, even in the medium to long term after discharge from acute hospital care. Also to be taken into account are the logistical difficulties imposed by restrictions on the movement of individuals within the territory for both patients and caregivers, which are amplified in remote or poorly served areas, such as many cross-border territories. In this context, telerehabilitation can provide solutions to assist healthcare facilities in managing the demand for rehabilitation in the territory using a 'digital' therapist. The main objective of this project is therefore to identify the appropriate technology to administer the rehabilitation programme to patients and apply to a group of post-COVID-19 patients a customised respiratory and/or motor rehabilitation programme to be carried out directly at the patients' home after hospital discharge in order to evaluate its effects.

Registry
clinicaltrials.gov
Start Date
July 26, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients admitted to a rehabilitation facility for functional recovery in disabling motor and/or respiratory outcomes of severe acute respiratory syndrome COronaVirus 2 (SARS-CoV2) infection and residing in cross-border regions with a low density of rehabilitation offerings.

Exclusion Criteria

  • Psychiatric disorders/cognitive impairments that do not allow proper use of tablets and breathing training devices.

Outcomes

Primary Outcomes

Change from baseline balance and functional mobility.

Time Frame: up to 8 weeks

Measurement of balance and functional mobility using Timed Up and Go test (TUG) at baseline (upon admission, T0), 3-4 weeks later after multidisciplinary rehabilitation + respiratory and motor training (at discharge, T1) and after 3-4 weeks of telerehabilitation (T2).

Change from baseline aerobic endurance.

Time Frame: up to 8 weeks

Measurement of aerobic endurance using the six-minutes walk test (6MWT) at baseline (upon admission, T0), 3-4 weeks later after multidisciplinary rehabilitation + respiratory and motor training (at discharge, T1) and after 3-4 weeks of telerehabilitation (T2).

Change from baseline isometric strength.

Time Frame: up to 8 weeks

Measurement of isometric strength using the handgrip test (kg) at baseline (upon admission, T0), 3-4 weeks later after multidisciplinary rehabilitation + respiratory and motor training (at discharge, T1) and after 3-4 weeks of telerehabilitation (T2).

Change from baseline in the pulmonary function test.

Time Frame: up to 8 weeks

Performing a spirometry test with diffusing capacity of the lungs for carbon monoxide (DLCO) at baseline (upon admission, T0), 3-4 weeks later after multidisciplinary rehabilitation + respiratory and motor training (at discharge, T1) and after 3-4 weeks of telerehabilitation (T2).

Change from baseline in several respiratory measures.

Time Frame: up to 8 weeks

Performing force vital capacity (FVC), maximum inspiratory (MIP) and expiratory (MEP) pressure and two one-minute maximum voluntary ventilation respiratory tests with the SpiroTiger device (first test with a ventilatory rate of 26 acts/min with increased load on the inspiratory muscles and second test with a ventilatory rate of 34 acts/min with increased load on the expiratory muscles) at baseline (upon admission, T0), 3-4 weeks later after multidisciplinary rehabilitation + respiratory and motor training (at discharge, T1) and after 3-4 weeks of telerehabilitation (T2).

Study Sites (2)

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