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

Pulmonary Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368793
• Other study ID #: 2020-22-K17
• Status: Recruiting
• Start date: April 6, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: China-Japan Friendship Hospital
• Contact: Geyi Wen, Resident
• Phone: +86 13263370980
• Email: williamwgy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-2019 Pneumonia
• Pneumonia
• Pulmonary Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
China	Wuhan Central Hospital	Wuhan	Hubei
China	Wuhan Lung Hospital	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	Ai You Foundation, Wuhan central hospital, Wuhan lung Hospital, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walking distance (6MWD)	Walking distance within six minutes	One year
Primary	Pulmonary function	Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.	One year
Secondary	Respiratory muscle strength	Maximal inspiratory pressure, maximal expiratory pressure, etc.	One year
Secondary	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
Secondary	Symptom	Modified British Medical Research Council (mMRC) dyspnea scale, etc.	One year
Secondary	Psychological evaluation	Self-training depression scale (SDS) and self-rating anxiety scale (SAS)	One year
Secondary	Quality of life	36-item short-form health survey (SF-36), etc.	One year
Secondary	Physical activity	International physical activity questionnaire (IPAQ)	One year
Secondary	Proportion of returning to society	Proportions of returning to routine work and normal life	One year