Clinical trial NCT04368793: Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge
Official title: Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-2019 Pneumonia
Pulmonary Rehabilitation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan lung Hospital
name: Wuhan Central Hospital
name: Wuhan University
name: Ai You Foundation
First posted: 2020-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Six-minute walking distance (6MWD)
timeFrame: One year
measure: Pulmonary function
timeFrame: One year
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: One year
measure: Physical fitness assessment
timeFrame: One year
measure: Symptom
timeFrame: One year
measure: Psychological evaluation
timeFrame: One year
measure: Quality of life
timeFrame: One year
measure: Physical activity
timeFrame: One year
measure: Proportion of returning to society
timeFrame: One year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Lung Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.