Telerehabilitation in the Post-COVID-19 Patient (TRIALS)

Post-COVID-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05739552
• Other study ID #: 31A101
• Status: Completed
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

Other:
• Telerehabilitation program
Application of customised respiratory and/or motor rehabilitation exercises to be carried out directly at the patients' home after hospital discharge in order to evaluate its effects.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Oggebbio	VB
Switzerland	Clinica Hildebrand	Brissago

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Politecnico di Milano

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline aerobic endurance.	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).	up to 8 weeks
Primary	Change from baseline balance and functional mobility.	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).	up to 8 weeks
Primary	Change from baseline isometric strength.	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).	up to 8 weeks
Primary	Change from baseline in several respiratory measures.	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).	up to 8 weeks
Primary	Change from baseline in the pulmonary function test.	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).	up to 8 weeks