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

• Conditions: Pulmonary Rehabilitation; COVID-2019 Pneumonia
• Interventions: Behavioral: Remote pulmonary rehabilitation

• Registration Number: NCT04368793
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-06
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Discharged COVID-19 patient cohort	Remote pulmonary rehabilitation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Wuhan Lung Hospital; 🇨🇳 Wuhan, Hubei, China

Wuhan Central Hospital; 🇨🇳 Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China