Influence of Early Standing Training on ICU Patients

July 1, 2020 updated by: wang kaifei, Chinese PLA General Hospital
Influence of early standing training on ICU patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
Early standing training and routine rehabilitation
Behavioral: Intensive rehabilitation
Early standing training and routine rehabilitation
Active Comparator: control group
Conventional rehabilitation，Muscle training and breathing training
Behavioral: Intensive rehabilitation
Early standing training and routine rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medical Research Council
Time Frame: day 1
Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.
day 1
Medical Research Council
Time Frame: day 7
Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.
day 7
Medical Research Council
Time Frame: day 14
Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.
day 14
Berg Balance Scale
Time Frame: day 1
Balance grade score,The highest 56 points,The higher the score, the better the balance.
day 1
Berg Balance Scale
Time Frame: day 7
Balance grade score,The highest 56 points,The higher the score, the better the balance.
day 7
Berg Balance Scale
Time Frame: day 14
Balance grade score,The highest 56 points,The higher the score, the better the balance.
day 14
FIM Function Independent Scale
Time Frame: day 1
Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
day 1
FIM Function Independent Scale
Time Frame: day 7
Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
day 7
FIM Function Independent Scale
Time Frame: day 14
Functional independence assessment,The lowest score is 18 and the highest is 126,The higher the score, the more independent it is.
day 14
Holden walk classification
Time Frame: day 1
Levels 0 to 5,The higher the grade, the better the ability to walk
day 1
Holden walk classification
Time Frame: day 7
Levels 0 to 5,The higher the grade, the better the ability to walk
day 7
Holden walk classification
Time Frame: day 14
Levels 0 to 5,The higher the grade, the better the ability to walk
day 14
arterial blood gas analysis
Time Frame: day 1
PH,normal range 7.35-7.45
day 1
arterial blood gas analysis
Time Frame: day 7
PH,normal range 7.35-7.45
day 7
arterial blood gas analysis
Time Frame: day 14
PH,normal range 7.35-7.45
day 14
partial pressure of carbon dioxide
Time Frame: day 1
normal range 35-45 mmHg
day 1
partial pressure of carbon dioxide
Time Frame: day 7
normal range 35-45 mmHg
day 7
partial pressure of carbon dioxide
Time Frame: day 14
normal range 35-45 mmHg
day 14
oxygenation index
Time Frame: day 1
Normal adults are 400,the higher，the better
day 1
oxygenation index
Time Frame: day 7
Normal adults are 400,the higher，the better
day 7
oxygenation index
Time Frame: day 14
Normal adults are 400,the higher，the better
day 14
lactic acid
Time Frame: day 1
normal range 0.5-1.6mmol/L
day 1
lactic acid
Time Frame: day 7
normal range 0.5-1.6mmol/L
day 7
lactic acid
Time Frame: day 14
normal range 0.5-1.6mmol/L
day 14
Diaphragmatic movement
Time Frame: day 1
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
day 1
Diaphragmatic movement
Time Frame: day 7
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
day 7
Diaphragmatic movement
Time Frame: day 14
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
day 14
Diaphragm contraction rate
Time Frame: day 1
Normal adults are 1.3cm/s
day 1
Diaphragm contraction rate
Time Frame: day 7
Normal adults are 1.3cm/s
day 7
Diaphragm contraction rate
Time Frame: day 14
Normal adults are 1.3cm/s
day 14
Diaphragm thickness at end of breath
Time Frame: day 1
Normal adults are 0.15cm
day 1
Diaphragm thickness at end of breath
Time Frame: day 7
Normal adults are 0.15cm
day 7
Diaphragm thickness at end of breath
Time Frame: day 14
Normal adults are 0.15cm
day 14
Diaphragm thickness at end of inhalation
Time Frame: day 1
Normal adults are 0.28cm
day 1
Diaphragm thickness at end of inhalation
Time Frame: day 7
Normal adults are 0.28cm
day 7
Diaphragm thickness at end of inhalation
Time Frame: day 14
Normal adults are 0.28cm
day 14
Diaphragmatic thickness variation rate
Time Frame: day 1
Less than 20% have diaphragmatic dysfunction
day 1
Diaphragmatic thickness variation rate
Time Frame: day 7
Less than 20% have diaphragmatic dysfunction
day 7
Diaphragmatic thickness variation rate
Time Frame: day 14
Less than 20% have diaphragmatic dysfunction
day 14
E-T index
Time Frame: day 1
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
day 1
E-T index
Time Frame: day 7
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
day 7
E-T index
Time Frame: day 14
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
day 14
Timed Inspiration
Time Frame: day 1
Normal adults are 1s
day 1
Timed Inspiration
Time Frame: day 7
Normal adults are 1s
day 7
Timed Inspiration
Time Frame: day 14
Normal adults are 1s
day 14
Rectus femoris thickness
Time Frame: day 1
The thicker the muscle, the better
day 1
Rectus femoris thickness
Time Frame: day 7
The thicker the muscle, the better
day 7
Rectus femoris thickness
Time Frame: day 14
The thicker the muscle, the better
day 14
Thickness of tibialis anterior muscle
Time Frame: day 1
The thicker the muscle, the better
day 1
Thickness of tibialis anterior muscle
Time Frame: day 7
The thicker the muscle, the better
day 7
Thickness of tibialis anterior muscle
Time Frame: day 14
The thicker the muscle, the better
day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mechanical ventilation time
Time Frame: three months
Mechanical ventilation time
three months
icu length of stay
Time Frame: three months
icu length of stay
three months
Time required for independent walking
Time Frame: three months
Time required for independent walking
three months
delirium
Time Frame: 28 days
Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.
28 days
mortality
Time Frame: 28 days
mortality
28 days
reintubation
Time Frame: 28 days
Note whether intubation was performed within 28 days.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: xin li xie, The First Medical Center of PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Intensive rehabilitation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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