COVID-19NCT04695301
Functional Outcomes in COVID-19 Survivors and Use of a Digital Platform for Rehabilitation
A study testing Rehabilitation protocol through a digital platform in people with COVID-19 and Coronavirus Infections, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Coronavirus Infections, Exercise Therapy
- What is being tested?
- Rehabilitation protocol through a digital platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women affected by COVID-19
- over 18 years of age, admitted to HIAE partner hospitals
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, 05652-000
About this study
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.
Read the 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
- Being tested
- Rehabilitation protocol through a digital platform
- Keywords
- Telemedicine, exercise therapy, coronavirus infections, stress disorders traumatic, fatigue, quality of life
- Medical subject headings
- COVID-19, Coronavirus Infections, Stress Disorders, Traumatic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocol through a digital platformOther
During 3 months the patients will participate in a rehabilitation program through a digital platform
| Study group | Role | What they receive |
|---|---|---|
| digital platform rehabilitation | Experimental | Rehabilitation program through a digital platform for 3 months Receives: Other: Rehabilitation protocol through a digital platform |
| control group | Experimental | Patients without access to technology will do the exercises using booklets and will compose the control group Receives: Other: Rehabilitation protocol through a digital platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (3)
Assess clinical and demographic data
Assess clinical and demographic data
Measured: 3 months
Assess functional level at hospital discharge
Assess functional level at hospital discharge and 3 months after discharge by physical test
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciana D Matos, MD,PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695301
- Sponsor's protocol ID
- 34170820.0.1001.0071
- Status last verified
- Jul 2020
- First submitted
- 29 Dec 2020
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in COVID-19 Survivors and Use of a Digital Platform for Rehabilitation
- ClinicalTrials.gov ID
- NCT04695301
- Acronym / sponsor ID
- 34170820.0.1001.0071
- Conditions
- COVID-19, Coronavirus Infections, Exercise Therapy
- Keywords
- Telemedicine, exercise therapy, coronavirus infections, stress disorders traumatic, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| digital platform rehabilitation | Experimental | Other: Rehabilitation protocol through a digital platformRehabilitation program through a digital platform for 3 months |
| control group | Experimental | Other: Rehabilitation protocol through a digital platformPatients without access to technology will do the exercises using booklets and will compose the control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women affected by COVID-19
- over 18 years of age, admitted to HIAE partner hospitals
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation protocol through a digital platformDuring 3 months the patients will participate in a rehabilitation program through a digital platform | Other | control group, digital platform rehabilitation |
Primary outcome
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
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
3 secondary outcomes
Assess clinical and demographic data
Time frame: 3 months
Assess functional level at hospital discharge
Time frame: 3 months
Assess patient compliance of the rehabilitation program using the digital platform
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana D Matos, MD,PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation protocol through a digital platform in people with COVID-19 and Coronavirus Infections, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the clinical function profile of patients affected by COVID-19 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.