Covid19NCT04382534
A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction
An observational study of Covid19 and Respiratory Rehabilitation, run by Peking University Third Hospital at 1 site in China.
Trial summary
Post-discharge rehabilitation regimens for covid-19 patients have not been supported by high-quality evidence-based medical evidence.The first part of this study is a cross-sectional study.The contents of the study were the factors related to the dysfunction of COVID - 19 patients after discharge from the hospital in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Respiratory Rehabilitation, Cross-sectional Study
- What is being tested?
- Respiratory rehabilitation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2020to 31 Dec 2020
- Phase
- Observational
- 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
Study population: Patients with COVID-19 after discharge
Who may be able to join
- patients with definite diagnosis of COVID-19 normal or severe
- patients who entered the isolation point <3 days after discharge
- 18-80 years old
- agree to join the queue
Who cannot join
- body temperature >38°C
- heart rate >120 times/min or <40 times/min, systolic blood pressure <90mmHg or >180mmHg, respiratory rate >25 times/min in calm state.Or above vital signs fluctuate significantly.
- continuous oxygen therapy is required.
- patients with myocarditis, pulmonary hypertension, congestive heart failure, fresh venous thromboembolic diseases, unstable fractures and other inappropriate exercise
- patients with consciousness disorders, severe sequelae of cerebral infarction, cognitive dysfunction, mental disorders, severe balance disorders, and severe bone and joint diseases, which affect evaluation and treatment
- other conditions that cannot be cooperated with rehabilitation treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huarunwugang general hospital
Wuhan, Hubei
Yuanmingfei Zhang, Dr., +86 15201469083, zymf@pku.edu.cn
About this study
Post-discharge rehabilitation regimens for covid-19 patients have not been supported by high-quality evidence-based medical evidence.The first part of this study is a cross-sectional study.The contents of the study were the factors related to the dysfunction of COVID - 19 patients after discharge from the hospital in Wuhan.The second part of this study is a cohort study.To observe the functional changes of COVID-19 patients after discharge in hospital rehabilitation, home rehabilitation and no rehabilitation, in order to propose a more safe and effective rehabilitation program.
- Being tested
- Respiratory rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rehabilitationCombination product
Health education and energy saving techniques, chest activity training, local lung dilation techniques, breathing training, airway clearance training, aerobic exercise, resistance training
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation guidance group | 1 to 2 times of rehabilitation instruction according to the rehabilitation instruction program, either online or in person.According to the rehabilitation instruction, the patient performed self-rehabilitation exercises in the isolation point. | |
| Systematic rehabilitation treatment | According to the systematic rehabilitation treatment program, the rehabilitation therapist entered the home for one-to-one rehabilitation treatment, once a day, for a total of 10 days. Receives: Combination Product: Respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and signs
To take a history and physical examination
Measured: Ten days
Respiratory function
To take a physical examination and mMRC
Measured: Ten days
The body function
To take a MMT, 6-min walking test and Borg Index
Measured: Ten days
ADL
To take a modified Barthel index
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start10 Mar 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382534
- Sponsor's protocol ID
- M20200421
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction
- ClinicalTrials.gov ID
- NCT04382534
- Acronym / sponsor ID
- M20200421
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 May 2020 (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.
Post-discharge rehabilitation regimens for covid-19 patients have not been supported by high-quality evidence-based medical evidence.The first part of this study is a cross-sectional study.The contents of the study were the factors related to the dysfunction of COVID - 19 patients after discharge from the hospital in Wuhan.The second part of this study is a cohort study.To observe the functional changes of COVID-19 patients after discharge in hospital rehabilitation, home rehabilitation and no rehabilitation, in order to propose a more safe and effective rehabilitation program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation guidance group | – | –1 to 2 times of rehabilitation instruction according to the rehabilitation instruction program, either online or in person.According to the rehabilitation instruction, the patient performed self-rehabilitation exercises in the isolation point. |
| Systematic rehabilitation treatment | – | Combination Product: Respiratory rehabilitationAccording to the systematic rehabilitation treatment program, the rehabilitation therapist entered the home for one-to-one rehabilitation treatment, once a day, for a total of 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 after discharge
Key inclusion criteria (4 listed)
- patients with definite diagnosis of COVID-19 normal or severe
- patients who entered the isolation point <3 days after discharge
- 18-80 years old
- agree to join the queue
Key exclusion criteria (6 listed)
- body temperature >38°C
- heart rate >120 times/min or <40 times/min, systolic blood pressure <90mmHg or >180mmHg, respiratory rate >25 times/min in calm state.Or above vital signs fluctuate significantly.
- continuous oxygen therapy is required.
- patients with myocarditis, pulmonary hypertension, congestive heart failure, fresh venous thromboembolic diseases, unstable fractures and other inappropriate exercise
- patients with consciousness disorders, severe sequelae of cerebral infarction, cognitive dysfunction, mental disorders, severe balance disorders, and severe bone and joint diseases, which affect evaluation and treatment
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 |
|---|---|---|
| Respiratory rehabilitationHealth education and energy saving techniques, chest activity training, local lung dilation techniques, breathing training, airway clearance training, aerobic exercise, resistance training | Combination product | Systematic rehabilitation treatment |
Primary outcome
Symptoms and signs
Time frame: Ten days
To take a history and physical examination
Respiratory function
Time frame: Ten days
To take a physical examination and mMRC
The body function
Time frame: Ten days
To take a MMT, 6-min walking test and Borg Index
ADL
Time frame: Ten days
To take a modified Barthel index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Respiratory Rehabilitation, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms and signs (time frame: Ten days). The study lists 4 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 May 2020.