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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Rehabilitation; COVID-2019 Pneumonia
• Intervention / Treatment: Behavioral: Remote pulmonary rehabilitation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Geyi Wen, Resident; Phone Number: +86 13263370980; Email: williamwgy@163.com
• Study Contact Backup: Name: Lulu Yang, Resident; Phone Number: +86 18810904716; Email: 1277403977@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Zhenshun Cheng, Doctor; Phone Number: +86 13627288300
    • Wuhan, Hubei, China, 100191
      • Recruiting
      • Wuhan Lung Hospital
      • Contact: Guangyun Guo, Doctor; Phone Number: +86 13886806423
    • Wuhan, Hubei, China, 430014
      • Recruiting
      • Wuhan Central Hospital
      • Contact: Yi Hu, Doctor; Phone Number: +86 13995618974

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Wuhan University; Wuhan Central Hospital; Wuhan lung Hospital; Ai You Foundation
• Investigators: Principal Investigator: Ting Yang, Prof., China-Japan Friendship Hospital

Publications and helpful links

General Publications

• Lei J, Yang L, Wen G, Qumu S, Ren X, Yang T. Pulmonary telerehabilitation and efficacy among discharged COVID-19 patients: Rational and design of a prospective real-world study. Clin Respir J. 2021 Nov;15(11):1158-1167. doi: 10.1111/crj.13422. Epub 2021 Aug 6.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 2020-22-K17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No