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RecruitingNCT04441151Updated Feb 9, 2026

Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

An interventional study of Pulmonary rehabilitation therapy in Pulmonary Disease, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pulmonary Disease

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03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 70 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy;
  • acute cardio-cerebrovascular events;
  • spinal or limb fractures;
  • active bleeding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Pulmonary rehabilitation therapy

    Behavioral: Pulmonary rehabilitation therapy

  • No intervention
    Control group

    Routine medical treatment

Interventions

  • BehavioralPulmonary rehabilitation therapy

    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.

06

What researchers measure

Primary outcomes

  1. MRC

    Medical Research Council,Muscle strength assessment,total points0\~60,less than 48scores means ICU aquired weaknesses.

    Time frame: Day 28

  2. STS

    Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.

    Time frame: Day 28

  3. 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.

    Time frame: Day 28

  4. Borg dyspnea score

    Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe

    Time frame: Day 28

  5. PaO2

    arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80\~100.

    Time frame: Day 28

  6. Oxygenation index

    arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.

    Time frame: Day 28

  7. Diaphragm mobility

    The distance the diaphragm drops during inhalation,normal is 1.4cm.

    Time frame: Day 28

  8. Diaphragm contraction velocity

    The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.

    Time frame: Day 28

  9. End-inspiratory diaphragm thickness

    The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.

    Time frame: Day 28

  10. End-expiratory diaphragm thickness

    The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.

    Time frame: Day 28

  11. Diaphragm thickness variation rate

    Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.

    Time frame: Day 28

Secondary outcomes

  1. ICU stay time

    icu length of stay

    Time frame: 3 month

  2. Hospitalization time

    Hospitalization time,length of stay in hospital.

    Time frame: Month 3

  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

    Time frame: Day 28

  4. Use of non-invasive ventilator

    Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.

    Time frame: Day 28

  5. Intubation

    Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days

    Time frame: Day 28

  6. mortality

    mortality

    Time frame: Day 28

  7. Complication

    The incidence of new complications(pressure sores、thrombus、aspiration).

    Time frame: Day 28

07

Study locations

1 of 1 sites recruiting
  • Chinese PLAGH Hospital
    Beijing, Beijing Municipality, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04441151
Lead sponsor
Chinese PLA General Hospital
Responsible party
wang kaifei (Ph.D., Chinese PLA General Hospital) — Principal investigator
First posted
Jun 22, 2020
Start date
Mar 20, 2025
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Feb 9, 2026

Study contacts

kai fei Wang
Contact
zhaoying301301@163.com
+861055499330 ext. 17600953801
wang, doctor
principal investigator · The First Medical Center of PLA General Hospital

Oversight

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

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