NCT04382534

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 11, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 26, 2020

Last Update Submit

May 7, 2020

Conditions

Covid19Respiratory RehabilitationCross-sectional StudyCohort Study

Outcome Measures

Primary Outcomes (4)

  • Symptoms and signs

    To take a history and physical examination

    Ten days

  • Respiratory function

    To take a physical examination and mMRC

    Ten days

  • The body function

    To take a MMT, 6-min walking test and Borg Index

    Ten days

  • ADL

    To take a modified Barthel index

    Ten days

Study Arms (2)

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

Interventions

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

Systematic rehabilitation treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COVID-19 after discharge

You may qualify if:

  • patients with definite diagnosis of COVID-19 normal or severe
  • patients who entered the isolation point \<3 days after discharge
  • years old
  • agree to join the queue

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huarunwugang general hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2020

First Posted

May 11, 2020

Study Start

March 10, 2020

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

May 11, 2020

Record last verified: 2020-04

Locations

CN(1)