Pulmonary DiseaseNCT04441151
Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
A study testing Pulmonary rehabilitation therapy in people with Pulmonary Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is ≥ 18 years old;
- the hemodynamics is stable;
- 50 < heart rate < 120 beats / min ;
- 90 < systolic blood pressure < 200mmHg ;
- 55 < mean arterial pressure < 120mmHg;
- do not increase the dose of pressor drugs for at least 2 hours;
Show all 10Show fewer
- intracranial pressure is stable and there are no seizures within 24 hours;
- the respiratory state is stable;
- the patient's finger pulse oxygen saturation ≥ 88%;
- 10 < respiratory frequency < 35 beats / min.
Who cannot join
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLAGH Hospital
Beijing, Beijing Municipality
wang kai fei Wang, doctor, +861055499330, zhaoying301301@163.com
About this study
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy
Read the detailed description
Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.
- Conditions
- Pulmonary Disease
- Being tested
- Pulmonary rehabilitation therapy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation therapyBehavioural
Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Pulmonary rehabilitation therapy Receives: Behavioral: Pulmonary rehabilitation therapy |
| Control group | No intervention | Routine medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRC
Medical Research Council,Muscle strength assessment,total points0~60，less than 48scores means ICU aquired weaknesses.
Measured: Day 28
STS
Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
Measured: Day 28
barthel index
barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.
Measured: Day 28
Borg dyspnea score
Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
Measured: Day 28
PaO2
arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
Measured: Day 28
Oxygenation index
arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
Measured: Day 28
Diaphragm mobility
The distance the diaphragm drops during inhalation,normal is 1.4cm.
Measured: Day 28
Diaphragm contraction velocity
The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
Measured: Day 28
End-inspiratory diaphragm thickness
The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
Measured: Day 28
End-expiratory diaphragm thickness
The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Measured: Day 28
Diaphragm thickness variation rate
Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
Measured: Day 28
Secondary outcomes (7)
ICU stay time
icu length of stay
Measured: 3 month
Hospitalization time
Hospitalization time,length of stay in hospital.
Measured: Month 3
The time it takes to get out of bed for the first time
The time it takes to get out of bed for the first time
Measured: Day 28
Use of non-invasive ventilator
Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
Measured: Day 28
Intubation
Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
Measured: Day 28
mortality
mortality
Measured: Day 28
Complication
The incidence of new complications(pressure sores、thrombus、aspiration).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start20 Mar 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
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 Chinese PLA General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
- Investigators
- wang, doctor, Principal investigator, The First Medical Center of PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441151
- Sponsor's protocol ID
- pulmonary rehabilitation
- Status last verified
- May 2025
- First submitted
- 16 Jun 2020
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
- ClinicalTrials.gov ID
- NCT04441151
- Acronym / sponsor ID
- pulmonary rehabilitation
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 Jun 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.
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy
Detailed description
Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Pulmonary rehabilitation therapyPulmonary rehabilitation therapy |
| Control group | No intervention | –Routine medical treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The age is ≥ 18 years old;
- the hemodynamics is stable;
- 50 < heart rate < 120 beats / min ;
- 90 < systolic blood pressure < 200mmHg ;
- 55 < mean arterial pressure < 120mmHg;
Key exclusion criteria (4 listed)
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
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 |
|---|---|---|
| Pulmonary rehabilitation therapyComprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time. | Behavioural | Experimental group |
Primary outcome
MRC
Time frame: Day 28
Medical Research Council,Muscle strength assessment,total points0~60，less than 48scores means ICU aquired weaknesses.
STS
Time frame: Day 28
Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
barthel index
Time frame: Day 28
barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.
Borg dyspnea score
Time frame: Day 28
Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
PaO2
Time frame: Day 28
arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
Oxygenation index
Time frame: Day 28
arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
Diaphragm mobility
Time frame: Day 28
The distance the diaphragm drops during inhalation,normal is 1.4cm.
Diaphragm contraction velocity
Time frame: Day 28
The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
End-inspiratory diaphragm thickness
Time frame: Day 28
The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
End-expiratory diaphragm thickness
Time frame: Day 28
The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Diaphragm thickness variation rate
Time frame: Day 28
Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
7 secondary outcomes
ICU stay time
Time frame: 3 month
Hospitalization time
Time frame: Month 3
The time it takes to get out of bed for the first time
Time frame: Day 28
Use of non-invasive ventilator
Time frame: Day 28
Intubation
Time frame: Day 28
mortality
Time frame: Day 28
Complication
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- 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.
wang, doctor principal investigator
The First Medical Center of PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation therapy in people with Pulmonary Disease, run by Chinese PLA General Hospital 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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kai fei Wang (+861055499330 ext. 17600953801, zhaoying301301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRC (time frame: Day 28). The study lists 11 primary outcomes in all. 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 9 Feb 2026.