NCT04441151

Brief Summary

Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
4.7 years until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

June 16, 2020

Last Update Submit

February 6, 2026

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (11)

  • MRC

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

    Day 28

  • STS

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

    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.

    Day 28

  • Borg dyspnea score

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

    Day 28

  • PaO2

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

    Day 28

  • Oxygenation index

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

    Day 28

  • Diaphragm mobility

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

    Day 28

  • Diaphragm contraction velocity

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

    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.

    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.

    Day 28

  • Diaphragm thickness variation rate

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

    Day 28

Secondary Outcomes (7)

  • ICU stay time

    3 month

  • Hospitalization time

    Month 3

  • The time it takes to get out of bed for the first time

    Day 28

  • Use of non-invasive ventilator

    Day 28

  • Intubation

    Day 28

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Pulmonary rehabilitation therapy

Behavioral: Pulmonary rehabilitation therapy

Control group

NO INTERVENTION

Routine medical treatment

Interventions

Pulmonary rehabilitation therapyBEHAVIORAL

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.

Experimental group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age is ≥ 18 years old;
  • the hemodynamics is stable;
  • \< heart rate \< 120 beats / min ;
  • \< systolic blood pressure \< 200mmHg ;
  • \< 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%;
  • \< respiratory frequency \< 35 beats / min.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLAGH Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • wang, doctor

    The First Medical Center of PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kai fei Wang

CONTACT

+861055499330zhaoying301301@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 22, 2020

Study Start

March 20, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 9, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)