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

Study Overview
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Brief Summary
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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.

Official Title
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Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients

Conditions
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COVID-2019 Pneumonia, Pulmonary Rehabilitation

Intervention / Treatment
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* Behavioral: Remote pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Discharged COVID-19 patient cohort<br>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<br>* The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walking distance (6MWD) | Walking distance within six minutes | One year | 
| Pulmonary function | Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | Maximal inspiratory pressure, maximal expiratory pressure, etc. | One year | 
| Physical fitness assessment | Two-minute walking test, short physical performance battery, grip strength of both upper limbs, knee extension strength of both lower limbs, etc. | One year | 
| Symptom | Modified British Medical Research Council (mMRC) dyspnea scale, etc. | One year | 
| Psychological evaluation | Self-training depression scale (SDS) and self-rating anxiety scale (SAS) | One year | 
| Quality of life | 36-item short-form health survey (SF-36), etc. | One year | 
| Physical activity | International physical activity questionnaire (IPAQ) | One year | 
| Proportion of returning to society | Proportions of returning to routine work and normal life | One year |