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Status unknownNCT04368793Updated Jul 17, 2020

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

An observational study in COVID-2019 Pneumonia and Pulmonary Rehabilitation, sponsored by China-Japan Friendship Hospital. Status unknown at 3 sites in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by China-Japan Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
20 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • COVID-2019 Pneumonia
  • Pulmonary Rehabilitation

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 200 is close to the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BehavioralRemote pulmonary rehabilitation

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

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What researchers measure

Primary outcomes

  1. Six-minute walking distance (6MWD)

    Walking distance within six minutes

    Time frame: One year

  2. Pulmonary function

    Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.

    Time frame: One year

Secondary outcomes

  1. Respiratory muscle strength

    Maximal inspiratory pressure, maximal expiratory pressure, etc.

    Time frame: One year

  2. 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.

    Time frame: One year

  3. Symptom

    Modified British Medical Research Council (mMRC) dyspnea scale, etc.

    Time frame: One year

  4. Psychological evaluation

    Self-training depression scale (SDS) and self-rating anxiety scale (SAS)

    Time frame: One year

  5. Quality of life

    36-item short-form health survey (SF-36), etc.

    Time frame: One year

  6. Physical activity

    International physical activity questionnaire (IPAQ)

    Time frame: One year

  7. Proportion of returning to society

    Proportions of returning to routine work and normal life

    Time frame: One year

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Study locations

3 of 3 sites recruiting
  • Wuhan Lung Hospital
    Wuhan, Hubei 100191, China
    • Guangyun Guo, Doctor · Contact · +86 13886806423
    Recruiting
  • Wuhan Central Hospital
    Wuhan, Hubei 430014, China
    • Yi Hu, Doctor · Contact · +86 13995618974
    Recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
    • Zhenshun Cheng, Doctor · Contact · +86 13627288300
    Recruiting
08

References and documents

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. PubMed 34260823 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04368793
Lead sponsor
China-Japan Friendship Hospital
Collaborators
Wuhan lung Hospital, Wuhan Central Hospital, Wuhan University, Ai You Foundation
Responsible party
Hongtao Niu (Doctor, China-Japan Friendship Hospital) — Principal investigator
First posted
Apr 30, 2020
Start date
Apr 6, 2020
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jul 17, 2020

Study contacts

Geyi Wen, Resident
Contact
williamwgy@163.com
+86 13263370980
Lulu Yang, Resident
Contact
1277403977@qq.com
+86 18810904716
Ting Yang, Prof.
principal investigator · China-Japan Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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