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Status unknownNCT04460391Updated Jul 7, 2020

Influence of Early Standing Training on ICU Patients

An interventional study of Intensive rehabilitation in Pulmonary Disease, sponsored by Chinese PLA General Hospital. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

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

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Influence of early standing training on ICU patients

Read the detailed description

Objective: To study the effect of early standing training on ICU patients.Background: Early severe rehabilitation is of great significance for patients, which can help patients withdraw from mechanical ventilation as soon as possible, improve pulmonary ventilation, and promote early walking.However, patients on mechanical ventilation are more prone to delirium, muscle weakness, ventilator dependence and other problems. Early standing training can significantly improve patients' lower limb muscle strength, improve diaphragm function, improve the prognosis of patients, and reduce the length of hospital stay.Methods: selecting stable hemodynamics in ICU patients with mechanical ventilation, randomly divided into two groups, a group of routine rehabilitation training, another group stand for regular rehabilitation and early training, with the aid of electric beds, on the first day of patients, to evaluate the seventh day, the 14th day, and collect the basic information for patients and strength assessment, blood gas analysis, the diaphragm of the bed and ultrasound and muscle ultrasound, and record the patient's mortality within 28 days, the incidence of delirium, decannulation rate, etc., recorded in patients with mechanical ventilation time and the time required to walk independently and ICU stay time.

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 50 is below 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%;
  • Oxygen concentration less than 60%；
  • Terminal positive expiratory pressure\<12cmH2O；
  • 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
50 participants (estimated)

Study arms

  • Experimental
    experimental group

    Early standing training and routine rehabilitation

    Behavioral: Intensive rehabilitation

  • Active comparator
    control group

    Conventional rehabilitation，Muscle training and breathing training

    Behavioral: Intensive rehabilitation

Interventions

  • BehavioralIntensive rehabilitation

    Early standing training and routine rehabilitation

06

What researchers measure

Primary outcomes

  1. Medical Research Council

    Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.

    Time frame: day 1

  2. Medical Research Council

    Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.

    Time frame: day 7

  3. Medical Research Council

    Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.

    Time frame: day 14

  4. Berg Balance Scale

    Balance grade score,The highest 56 points,The higher the score, the better the balance.

    Time frame: day 1

  5. Berg Balance Scale

    Balance grade score,The highest 56 points,The higher the score, the better the balance.

    Time frame: day 7

  6. Berg Balance Scale

    Balance grade score,The highest 56 points,The higher the score, the better the balance.

    Time frame: day 14

  7. FIM Function Independent Scale

    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.

    Time frame: day 1

  8. FIM Function Independent Scale

    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.

    Time frame: day 7

  9. FIM Function Independent Scale

    Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.

    Time frame: day 14

  10. Holden walk classification

    Levels 0 to 5,The higher the grade, the better the ability to walk

    Time frame: day 1

  11. Holden walk classification

    Levels 0 to 5,The higher the grade, the better the ability to walk

    Time frame: day 7

  12. Holden walk classification

    Levels 0 to 5,The higher the grade, the better the ability to walk

    Time frame: day 14

  13. arterial blood gas analysis

    PH,normal range 7.35-7.45

    Time frame: day 1

  14. arterial blood gas analysis

    PH,normal range 7.35-7.45

    Time frame: day 7

  15. arterial blood gas analysis

    PH,normal range 7.35-7.45

    Time frame: day 14

  16. partial pressure of carbon dioxide

    normal range 35-45 mmHg

    Time frame: day 1

  17. partial pressure of carbon dioxide

    normal range 35-45 mmHg

    Time frame: day 7

  18. partial pressure of carbon dioxide

    normal range 35-45 mmHg

    Time frame: day 14

  19. oxygenation index

    Normal adults are 400,the higher，the better

    Time frame: day 1

  20. oxygenation index

    Normal adults are 400,the higher，the better

    Time frame: day 7

  21. oxygenation index

    Normal adults are 400,the higher，the better

    Time frame: day 14

  22. lactic acid

    normal range 0.5-1.6mmol/L

    Time frame: day 1

  23. lactic acid

    normal range 0.5-1.6mmol/L

    Time frame: day 7

  24. lactic acid

    normal range 0.5-1.6mmol/L

    Time frame: day 14

  25. Diaphragmatic movement

    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

    Time frame: day 1

  26. Diaphragmatic movement

    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

    Time frame: day 7

  27. Diaphragmatic movement

    The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.

    Time frame: day 14

  28. Diaphragm contraction rate

    Normal adults are 1.3cm/s

    Time frame: day 1

  29. Diaphragm contraction rate

    Normal adults are 1.3cm/s

    Time frame: day 7

  30. Diaphragm contraction rate

    Normal adults are 1.3cm/s

    Time frame: day 14

  31. Diaphragm thickness at end of breath

    Normal adults are 0.15cm

    Time frame: day 1

  32. Diaphragm thickness at end of breath

    Normal adults are 0.15cm

    Time frame: day 7

  33. Diaphragm thickness at end of breath

    Normal adults are 0.15cm

    Time frame: day 14

  34. Diaphragm thickness at end of inhalation

    Normal adults are 0.28cm

    Time frame: day 1

  35. Diaphragm thickness at end of inhalation

    Normal adults are 0.28cm

    Time frame: day 7

  36. Diaphragm thickness at end of inhalation

    Normal adults are 0.28cm

    Time frame: day 14

  37. Diaphragmatic thickness variation rate

    Less than 20% have diaphragmatic dysfunction

    Time frame: day 1

  38. Diaphragmatic thickness variation rate

    Less than 20% have diaphragmatic dysfunction

    Time frame: day 7

  39. Diaphragmatic thickness variation rate

    Less than 20% have diaphragmatic dysfunction

    Time frame: day 14

  40. E-T index

    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

    Time frame: day 1

  41. E-T index

    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

    Time frame: day 7

  42. E-T index

    Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.

    Time frame: day 14

  43. Timed Inspiration

    Normal adults are 1s

    Time frame: day 1

  44. Timed Inspiration

    Normal adults are 1s

    Time frame: day 7

  45. Timed Inspiration

    Normal adults are 1s

    Time frame: day 14

  46. Rectus femoris thickness

    The thicker the muscle, the better

    Time frame: day 1

  47. Rectus femoris thickness

    The thicker the muscle, the better

    Time frame: day 7

  48. Rectus femoris thickness

    The thicker the muscle, the better

    Time frame: day 14

  49. Thickness of tibialis anterior muscle

    The thicker the muscle, the better

    Time frame: day 1

  50. Thickness of tibialis anterior muscle

    The thicker the muscle, the better

    Time frame: day 7

  51. Thickness of tibialis anterior muscle

    The thicker the muscle, the better

    Time frame: day 14

Secondary outcomes

  1. Mechanical ventilation time

    Mechanical ventilation time

    Time frame: three months

  2. icu length of stay

    icu length of stay

    Time frame: three months

  3. Time required for independent walking

    Time required for independent walking

    Time frame: three months

  4. delirium

    Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.

    Time frame: 28 days

  5. mortality

    mortality

    Time frame: 28 days

  6. reintubation

    Note whether intubation was performed within 28 days.

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04460391
Lead sponsor
Chinese PLA General Hospital
Responsible party
wang kaifei (Ph.D., Chinese PLA General Hospital) — Principal investigator
First posted
Jul 7, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Oct 1, 2021 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Jul 7, 2020

Study contacts

Zhao Ying
Contact
1412888703@qq.com
17600953801 ext. 17600953801
xin li xie
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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