COVID-2019 PneumoniaNCT04368793
Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge
An observational study of COVID-2019 Pneumonia and Pulmonary Rehabilitation, run by China-Japan Friendship Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- COVID-2019 Pneumonia, Pulmonary Rehabilitation
- What is being tested?
- Remote pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 6 Apr 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Wuhan Lung Hospital
Wuhan, Hubei, 100191
Guangyun Guo, Doctor, +86 13886806423
- Recruiting
Wuhan Central Hospital
Wuhan, Hubei, 430014
Yi Hu, Doctor, +86 13995618974
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhenshun Cheng, Doctor, +86 13627288300
About this study
Official title: 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.
- Conditions
- COVID-2019 Pneumonia, Pulmonary Rehabilitation
- Being tested
- Remote pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote pulmonary rehabilitationBehavioural
The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walking distance (6MWD)
Walking distance within six minutes
Measured: One year
Pulmonary function
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.
Measured: One year
Secondary outcomes (7)
Respiratory muscle strength
Maximal inspiratory pressure, maximal expiratory pressure, etc.
Measured: 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.
Measured: One year
Symptom
Modified British Medical Research Council (mMRC) dyspnea scale, etc.
Measured: One year
Psychological evaluation
Self-training depression scale (SDS) and self-rating anxiety scale (SAS)
Measured: One year
Quality of life
36-item short-form health survey (SF-36), etc.
Measured: One year
Physical activity
International physical activity questionnaire (IPAQ)
Measured: One year
Proportion of returning to society
Proportions of returning to routine work and normal life
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start6 Apr 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-2019 PneumoniaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan lung Hospital, Wuhan Central Hospital, Wuhan University, Ai You Foundation
- Responsible party
- Principal investigator, Hongtao Niu, China-Japan Friendship Hospital
- Investigators
- Ting Yang, Prof., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368793
- Sponsor's protocol ID
- 2020-22-K17
- Status last verified
- Jul 2020
- First submitted
- 23 Apr 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04368793
- Acronym / sponsor ID
- 2020-22-K17
- Conditions
- COVID-2019 Pneumonia, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Wuhan lung Hospital, Wuhan Central Hospital, Wuhan University, Ai You Foundation
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discharged COVID-19 patient cohort | – | Behavioral: Remote pulmonary rehabilitationAll 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote pulmonary rehabilitationThe pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc. | Behavioural | Discharged COVID-19 patient cohort |
Primary outcome
Six-minute walking distance (6MWD)
Time frame: One year
Walking distance within six minutes
Pulmonary function
Time frame: One year
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.
7 secondary outcomes
Respiratory muscle strength
Time frame: One year
Physical fitness assessment
Time frame: One year
Symptom
Time frame: One year
Psychological evaluation
Time frame: One year
Quality of life
Time frame: One year
Physical activity
Time frame: One year
Proportion of returning to society
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Derived from this study: PubMed 34260823Lei 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Yang, Prof. principal investigator
China-Japan Friendship Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-2019 Pneumonia and Pulmonary Rehabilitation, run by China-Japan Friendship Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geyi Wen, Resident (+86 13263370980, williamwgy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walking distance (6MWD) (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.