Pulmonary DiseaseNCT04922879
Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
A study testing Individualized lung rehabilitation in people with Pulmonary Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Individualized lung rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Mar 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after double lung transplantation; informed consent
Who cannot join
- unstable condition
Trial locations and contacts
1 site in 1 country.
About this study
Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.
Read the detailed description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
- Conditions
- Pulmonary Disease
- Being tested
- Individualized lung rehabilitation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized lung rehabilitationBehavioural
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
| Study group | Role | What they receive |
|---|---|---|
| Individualized lung rehabilitation programme | Experimental | Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support. Receives: Behavioral: Individualized lung rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU hospital stay
the stay time spent in ICU
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 May 2018
- Primary completion31 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- experience summary
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Zeng, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922879
- Sponsor's protocol ID
- 2020--499
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
- ClinicalTrials.gov ID
- NCT04922879
- Acronym / sponsor ID
- 2020--499
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 11 Jun 2021 (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.
Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.
Detailed description
Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- experience summary
| Arm | Type | Receives |
|---|---|---|
| Individualized lung rehabilitation programme | Experimental | Behavioral: Individualized lung rehabilitationEarly respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients after double lung transplantation; informed consent
Key exclusion criteria (1 listed)
- unstable condition
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 |
|---|---|---|
| Individualized lung rehabilitationEarly respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support. | Behavioural | Individualized lung rehabilitation programme |
Primary outcome
ICU hospital stay
Time frame: 1 year
the stay time spent in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Fei Zeng study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized lung rehabilitation in people with Pulmonary Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU hospital stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2021.