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

NCT05739552 | Completed

• 1 other identifier: 31A101
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

Other: Telerehabilitation program

Interventions

Telerehabilitation program OTHER

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.

Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Politecnico di Milano: collaborator

Study Sites (2)

Istituto Auxologico Italiano IRCCS

Oggebbio, VB, 28845, Italy

Location

Clinica Hildebrand

Brissago, 6614, Switzerland

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica Cimolin

  Politecnico di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 22, 2023
• Study Start: July 26, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); IT (1)