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

NCT ID: NCT04695301

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-10-01

Brief Summary

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.

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.

Conditions

COVID-19; Coronavirus Infections; Exercise Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

digital platform rehabilitation

Rehabilitation program through a digital platform for 3 months

Group Type: EXPERIMENTAL

Rehabilitation protocol through a digital platform

Intervention Type: OTHER

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

control group

Patients without access to technology will do the exercises using booklets and will compose the control group

Group Type: EXPERIMENTAL

Rehabilitation protocol through a digital platform

Intervention Type: OTHER

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

Interventions

Rehabilitation protocol through a digital platform

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana D Matos, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

34170820.0.1001.0071

Identifier Type: -

Identifier Source: org_study_id