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

Primary Purpose

COVID-19, Coronavirus Infections, Exercise Therapy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation protocol through a digital platform
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring Telemedicine, exercise therapy, coronavirus infections, stress disorders traumatic, fatigue, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

digital platform rehabilitation

control group

Arm Description

Rehabilitation program through a digital platform for 3 months

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2020
Last Updated
February 10, 2022
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT04695301
Brief Title
Functional Outcomes in COVID-19 Survivors and Use of a Digital Platform for Rehabilitation
Official Title
Functional Outcomes in COVID-19 Survivors and Use of a Digital Platform for Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus Infections, Exercise Therapy
Keywords
Telemedicine, exercise therapy, coronavirus infections, stress disorders traumatic, fatigue, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Men and women affected by COVID-19, over 18 years of age, admitted to HIAE partner hospitals who have been in hospital for more than 10 days or in need of treatment in semi-intensive or intensive care units will be selected. Follow-up will be carried out for 3 months, with remote reevaluations. During this period, the rehabilitation program will be offered for 3 months, through a digital platform.
Masking
Participant
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
digital platform rehabilitation
Arm Type
Experimental
Arm Description
Rehabilitation program through a digital platform for 3 months
Arm Title
control group
Arm Type
Experimental
Arm Description
Patients without access to technology will do the exercises using booklets and will compose the control group
Intervention Type
Other
Intervention Name(s)
Rehabilitation protocol through a digital platform
Intervention Description
During 3 months the patients will participate in a rehabilitation program through a digital platform
Primary Outcome Measure Information:
Title
Characterize the clinical function profile of patients affected by COVID-19
Description
Characterize the clinical functional profile of patients affected by COVID-19 by data from medical records
Time Frame
3 months
Title
Characterize the exercise capacity of patients affected by COVID-19
Description
Characterize the exercise capacity of patients affected by COVID-19 by 2-minute step test
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assess clinical and demographic data
Description
Assess clinical and demographic data
Time Frame
3 months
Title
Assess functional level at hospital discharge
Description
Assess functional level at hospital discharge and 3 months after discharge by physical test
Time Frame
3 months
Title
Assess patient compliance of the rehabilitation program using the digital platform
Description
Assess patient compliance of the rehabilitation program using the digital platform checking your adherence to the program
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana D Matos, MD,PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
City
São Paulo
ZIP/Postal Code
05652-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
when to published

Learn more about this trial

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

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