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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Other: Telerehabilitation program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • VB
    • Oggebbio, VB, Italy, 28845
      • Istituto Auxologico Italiano IRCCS
• Switzerland
  • Brissago, Switzerland, 6614
    • Clinica Hildebrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: Politecnico di Milano
• Investigators: Principal Investigator: Veronica Cimolin, Politecnico di Milano

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 31A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No