Pulmonary TransplantationNCT04912986
Construction and Application of Early Lung Rehabilitation Training Programs
A study testing Early Lung Rehabilitation Training and Routine treatment in people with Pulmonary Transplantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Transplantation
- What is being tested?
- Early Lung Rehabilitation Training and Routine treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Dec 2023
- 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
- age ≥ 18 years
- consent to early lung rehabilitation
- informed consent to this study.
Who cannot join
- Unstable condition, not allowed to receive pulmonary rehabilitation treatment
- A person with a mental disorder who cannot cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 310000
Fei Zeng, Bachelor, 13757119536, zengfei@zju.edu.cn
About this study
Official title: Construction and Application of Early Lung Rehabilitation Training Programs for Adult Patients After Double Lung Transplantation
This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve lung rehabilitation at an early date, improve patients' motor endurance and respiratory function, and improve the quality of near- and long-term survival.
Read the detailed description
The first stage constructs the lung rehabilitation program, and the second stage implements the non-contemporaneous study control trial.
- Conditions
- Pulmonary Transplantation
- Being tested
- Early Lung Rehabilitation Training, Routine treatment
- Keywords
- pulmonary transplantation, pulmonory rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Lung Rehabilitation TrainingBehavioural
It is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists.
Routine treatmentBehavioural
Provide rehabilitation training as usual, without standard program
| Study group | Role | What they receive |
|---|---|---|
| routine treatment | Placebo comparator | Review the collection of patient-related clinical data, collation of clinical data and outcome indicators Receives: Behavioral: Routine treatment |
| Experimental group | Experimental | The intervention was implemented in accordance with the Early Lung Rehabilitation Training Programme for Adult Double Lung Transplant Patients Receives: Behavioral: Early Lung Rehabilitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation time
The time for mechanical ventilation
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 posted3 Jun 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TransplantationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiangshuyuan Liang, Master, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912986
- Sponsor's protocol ID
- 2021-0232
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- 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 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of Early Lung Rehabilitation Training Programs for Adult Patients After Double Lung Transplantation
- ClinicalTrials.gov ID
- NCT04912986
- Acronym / sponsor ID
- 2021-0232
- Conditions
- Pulmonary Transplantation
- Keywords
- pulmonary transplantation, pulmonory rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 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.
This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve lung rehabilitation at an early date, improve patients' motor endurance and respiratory function, and improve the quality of near- and long-term survival.
Detailed description
The first stage constructs the lung rehabilitation program, and the second stage implements the non-contemporaneous study control trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine treatment | Placebo comparator | Behavioral: Routine treatmentReview the collection of patient-related clinical data, collation of clinical data and outcome indicators |
| Experimental group | Experimental | Behavioral: Early Lung Rehabilitation TrainingThe intervention was implemented in accordance with the Early Lung Rehabilitation Training Programme for Adult Double Lung Transplant Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- consent to early lung rehabilitation
- informed consent to this study.
Key exclusion criteria (2 listed)
- Unstable condition, not allowed to receive pulmonary rehabilitation treatment
- A person with a mental disorder who cannot cooperate.
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 |
|---|---|---|
| Early Lung Rehabilitation TrainingIt is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists. | Behavioural | Experimental group |
| Routine treatmentProvide rehabilitation training as usual, without standard program | Behavioural | routine treatment |
Primary outcome
Mechanical ventilation time
Time frame: 1 year
The time for mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
Jiangshuyuan Liang, Master 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 Early Lung Rehabilitation Training and Routine treatment in people with Pulmonary Transplantation, 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 3 inclusion and 2 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 3 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. Some participants in this study may receive a placebo. 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 Jiangshuyuan Liang, Master (13868058705, 2517140@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation time (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 3 Jun 2021.