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

NCT ID: NCT04368793

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-06

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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COVID-2019 Pneumonia Pulmonary Rehabilitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Remote pulmonary rehabilitation

Intervention Type BEHAVIORAL

The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan lung Hospital

UNKNOWN

Sponsor Role collaborator

Wuhan Central Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Ai You Foundation

UNKNOWN

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongtao Niu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ting Yang, Prof.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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Wuhan Lung Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Wuhan Central Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Geyi Wen, Resident

Role: CONTACT

+86 13263370980

Lulu Yang, Resident

Role: CONTACT

+86 18810904716

Facility Contacts

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Guangyun Guo, Doctor

Role: primary

+86 13886806423

Yi Hu, Doctor

Role: primary

+86 13995618974

Zhenshun Cheng, Doctor

Role: primary

+86 13627288300

References

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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.

Reference Type DERIVED
PMID: 34260823 (View on PubMed)

Other Identifiers

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2020-22-K17

Identifier Type: -

Identifier Source: org_study_id

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