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Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368793
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Wuhan lung Hospital
Wuhan central hospital
Wuhan University
Ai You Foundation
Information provided by (Responsible Party):
Hongtao Niu, China-Japan Friendship Hospital

Study Description
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Brief Summary:
The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City.

Condition or disease Intervention/treatment
COVID-2019 Pneumonia Pulmonary Rehabilitation Behavioral: Remote pulmonary rehabilitation

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Discharged COVID-19 patient cohort
All enrolled participants will be given 8 weeks (online 2 weeks + offline 6 weeks) pulmonary rehabilitation intervention, and will be followed up for at least one year, to assess their adherence and efficacy of the rehabilitation program.
 Behavioral: Remote pulmonary rehabilitation
The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.


Outcome Measures
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Primary Outcome Measures :
  1. Six-minute walking distance (6MWD) [ Time Frame: One year ]
    Walking distance within six minutes

  2. Pulmonary function [ Time Frame: One year ]
    Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.


Secondary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: One year ]
    Maximal inspiratory pressure, maximal expiratory pressure, etc.

  2. Physical fitness assessment [ Time Frame: One year ]
    Two-minute walking test, short physical performance battery, grip strength of both upper limbs, knee extension strength of both lower limbs, etc.

  3. Symptom [ Time Frame: One year ]
    Modified British Medical Research Council (mMRC) dyspnea scale, etc.

  4. Psychological evaluation [ Time Frame: One year ]
    Self-training depression scale (SDS) and self-rating anxiety scale (SAS)

  5. Quality of life [ Time Frame: One year ]
    36-item short-form health survey (SF-36), etc.

  6. Physical activity [ Time Frame: One year ]
    International physical activity questionnaire (IPAQ)

  7. Proportion of returning to society [ Time Frame: One year ]
    Proportions of returning to routine work and normal life


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All discharged COVID-19 pneumonia patients who have signed the informed consent and met above eligibility criteria will be enrolled in this study.
Criteria

Inclusion criteria:

  • patients diagnosed as COVID-19 pneumonia according to the Chinese diagnostic criteria (Trial 7th Edition), aged 20 years or above;
  • patients who did not participate in any other rehabilitation training scheme;
  • patients who did not participate in any other intervention clinical trials;
  • patients who signed the informed consent and were able to adhere to a long-term follow-up for at least one year.

Exclusion criteria:

  • pregnant women;
  • patients with previous mental disorders or undergoing mental health treatment;
  • patients with previous personality disorder, intelligence disorder, brain injury or brain disease;
  • patients with serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;
  • patients with tumors and underwent treatment.

One will be considered as withdrawal if consent is revoked, lost to follow-up, or unable to take the pulmonary rehabilitation scheme due to severe exacerbation, comorbidities, injury or trauma, etc.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368793


Contacts
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Contact: Geyi Wen, Resident +86 13263370980 williamwgy@163.com
Contact: Lulu Yang, Resident +86 18810904716 1277403977@qq.com

Locations
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China, Hubei
Wuhan Lung Hospital Recruiting
Wuhan, Hubei, China, 100191
Contact: Guangyun Guo, Doctor    +86 13886806423      
Wuhan Central Hospital Recruiting
Wuhan, Hubei, China, 430014
Contact: Yi Hu, Doctor    +86 13995618974      
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430071
Contact: Zhenshun Cheng, Doctor    +86 13627288300      
Sponsors and Collaborators
China-Japan Friendship Hospital
Wuhan lung Hospital
Wuhan central hospital
Wuhan University
Ai You Foundation
Investigators
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Principal Investigator: Ting Yang, Prof. China-Japan Friendship Hospital
More Information
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Responsible Party: Hongtao Niu, Doctor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT04368793    
Other Study ID Numbers: 2020-22-K17
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections