Telerehabilitation in the Post-COVID-19 Patient (TRIALS)
Primary Purpose
Post-COVID-19 Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telerehabilitation program
Sponsored by
About this trial
This is an interventional supportive care trial for Post-COVID-19 Syndrome
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.
Sites / Locations
- Istituto Auxologico Italiano IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telerehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05739552
First Posted
February 20, 2023
Last Updated
February 23, 2023
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT05739552
Brief Title
Telerehabilitation in the Post-COVID-19 Patient (TRIALS)
Official Title
Telerehabilitation in the Post-COVID-19 Patient: the Italy-Switzerland Experience
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telerehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline aerobic endurance.
Description
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).
Time Frame
up to 8 weeks
Title
Change from baseline balance and functional mobility.
Description
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).
Time Frame
up to 8 weeks
Title
Change from baseline isometric strength.
Description
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).
Time Frame
up to 8 weeks
Title
Change from baseline in several respiratory measures.
Description
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).
Time Frame
up to 8 weeks
Title
Change from baseline in the pulmonary function test.
Description
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).
Time Frame
up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacopo M Fontana
Phone
+393534297935
Email
j.fontana@auxologico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Capodaglio
Phone
+390323 514 331
Email
veronica.cimolin@polimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Cimolin
Organizational Affiliation
Politecnico di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Oggebbio
State/Province
VB
ZIP/Postal Code
28845
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacopo M Fontana
Phone
+393534297935
Email
j.fontana@auxologico.it
First Name & Middle Initial & Last Name & Degree
Paolo Capodaglio
Phone
+390323514331
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation in the Post-COVID-19 Patient (TRIALS)
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