A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction

May 7, 2020 updated by: Peking University Third Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Huarunwugang general hospital
        • Contact:
          • Yuanmingfei Zhang, Dr.
          • Phone Number: +86 15201469083
          • Email: zymf@pku.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COVID-19 after discharge

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Combination product: Respiratory rehabilitation
Health education and energy saving techniques, chest activity training, local lung dilation techniques, breathing training, airway clearance training, aerobic exercise, resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms and signs
Time Frame: Ten days
To take a history and physical examination
Ten days
Respiratory function
Time Frame: Ten days
To take a physical examination and mMRC
Ten days
The body function
Time Frame: Ten days
To take a MMT, 6-min walking test and Borg Index
Ten days
ADL
Time Frame: Ten days
To take a modified Barthel index
Ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2020

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20200421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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