Functional Outcomes in COVID-19 Survivors and Use of a Digital Platform for Rehabilitation

COVID-19, an acute respiratory disease caused by coronavirus-2 (SARS-CoV-2), and in most cases, causes mild to moderate symptoms of fever, cough and dyspnea. However, a not insignificant portion, given the total number of people affected, will present symptoms of severe acute respiratory failure and multiple organ failure, requiring hospitalization under intensive care, use of mechanical ventilation, prolonged period of immobilization and, consequently, physical, cognitive and psychological damage, which may affect survivors for a long period after hospitalization. All of these factors are known to have an impact on various areas of life: personal, social and economic, which makes the need for continued specific care after hospital discharge relevant. In this context, the role of rehabilitation programs is fundamental, aiming not only at a safer dehospitalization, but also at the continuity of care with the objective of restoring the biopsychosocial skills of these individuals, allowing functional independence for activities of daily life and a shorter return physical and social activities performed before the disease. However, the big challenge for the health system is how to offer this on a large scale. Therefore, knowing the clinical and functional profile of these patients at discharge and verifying the viability of a digital platform for rehabilitation and monitoring of these patients is the first step to allow the creation of a new form of continuity of care and access to affected patients with serious diseases such as COVID-19 and other syndromes capable of generate functional impairment. Therefore,the investigators objective is to characterize and monitor the functional profile and exercise capacity of patients affected by COVID-19 at the hospital discharge, as well as to verify the viability and compliance of patients to the use of a digital platform for the application of a distance rehabilitation program.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections; COVID-19; Exercise Therapy
• Intervention / Treatment: Other: Rehabilitation protocol through a digital platform

Detailed Description

The investigators proposal is to characterize and evaluate the impact of the disease on the clinical, functional and social aspects in these patients affected by COVID-19 and to propose the continuity of specific care after hospital discharge with a physical rehabilitation program through a digital platform, remotely for a period of 3 months. The proposed hypothesis is that patients convalescing from COVID-19 and undergoing the rehabilitation program will have a gain in functional skills and quality of life. The professional team involved in this study will be responsible for managing, monitoring and evaluating the participating patients and monitoring the performance of the proposed functional exercises.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05652-000
    • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women affected by COVID-19
• over 18 years of age, admitted to HIAE partner hospitals

Exclusion Criteria:

• presence of a physical or cognitive condition that makes it impossible or contraindicated to perform the 2-minute stride test and perform the proposed exercises.
• Patients with a more severe clinical and functional profile,
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital platform rehabilitation; Rehabilitation program through a digital platform for 3 months	Other: Rehabilitation protocol through a digital platform; During 3 months the patients will participate in a rehabilitation program through a digital platform
Experimental: control group; Patients without access to technology will do the exercises using booklets and will compose the control group	Other: Rehabilitation protocol through a digital platform; During 3 months the patients will participate in a rehabilitation program through a digital platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the clinical function profile of patients affected by COVID-19	Characterize the clinical functional profile of patients affected by COVID-19 by data from medical records	3 months
Characterize the exercise capacity of patients affected by COVID-19	Characterize the exercise capacity of patients affected by COVID-19 by 2-minute step test	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess clinical and demographic data	Assess clinical and demographic data	3 months
Assess functional level at hospital discharge	Assess functional level at hospital discharge and 3 months after discharge by physical test	3 months
Assess patient compliance of the rehabilitation program using the digital platform	Assess patient compliance of the rehabilitation program using the digital platform checking your adherence to the program	3 months

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Luciana D Matos, MD,PhD, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; fatigue; quality of life; exercise therapy; coronavirus infections; stress disorders traumatic
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 34170820.0.1001.0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: when to published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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