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OpenTrials
Completed

NCT Number: NCT04695301

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation protocol through a digital platform

Other

During 3 months the patients will participate in a rehabilitation program through a digital platform

Primary outcomes

  1. Characterize the clinical function profile of patients affected by COVID-19

    Time frame: 3 months

    Characterize the clinical functional profile of patients affected by COVID-19 by data from medical records

  2. Characterize the exercise capacity of patients affected by COVID-19

    Time frame: 3 months

    Characterize the exercise capacity of patients affected by COVID-19 by 2-minute step test

Secondary outcomes

  1. Assess clinical and demographic data

    Time frame: 3 months

    Assess clinical and demographic data

  2. Assess functional level at hospital discharge

    Time frame: 3 months

    Assess functional level at hospital discharge and 3 months after discharge by physical test

  3. Assess patient compliance of the rehabilitation program using the digital platform

    Time frame: 3 months

    Assess patient compliance of the rehabilitation program using the digital platform checking your adherence to the program

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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