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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382534
• Other study ID #: M20200421
• Status: Recruiting
• Start date: March 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cohort Study
• Covid19
• Cross-sectional Study
• Respiratory Rehabilitation

Intervention

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

Locations

Country	Name	City	State
China	Huarunwugang general hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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