Pulmonary DiseaseNCT04460391
Influence of Early Standing Training on ICU Patients
A study testing Intensive rehabilitation in people with Pulmonary Disease, run by Chinese PLA General Hospital.
Trial summary
Influence of early standing training on ICU patients 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?
- Intensive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12Show 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%;
- Oxygen concentration less than 60%；
- Terminal positive expiratory pressure<12cmH2O；
- 10 < respiratory frequency < 35 beats / min.
Who cannot join
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Pulmonary Disease
- Being tested
- Intensive rehabilitation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive rehabilitationBehavioural
Early standing training and routine rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Early standing training and routine rehabilitation Receives: Behavioral: Intensive rehabilitation |
| control group | Active comparator | Conventional rehabilitation，Muscle training and breathing training Receives: Behavioral: Intensive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Council
Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.
Measured: day 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.
Measured: day 7
Medical Research Council
Muscle strength assessment of ICU patients，Out of 60 points，Less than 48 points had acquired muscle weakness in the ICU.
Measured: day 14
Berg Balance Scale
Balance grade score,The highest 56 points,The higher the score, the better the balance.
Measured: day 1
Berg Balance Scale
Balance grade score,The highest 56 points,The higher the score, the better the balance.
Measured: day 7
Berg Balance Scale
Balance grade score,The highest 56 points,The higher the score, the better the balance.
Measured: day 14
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.
Measured: day 1
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.
Measured: day 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.
Measured: day 14
Holden walk classification
Levels 0 to 5,The higher the grade, the better the ability to walk
Measured: day 1
Holden walk classification
Levels 0 to 5,The higher the grade, the better the ability to walk
Measured: day 7
Holden walk classification
Levels 0 to 5,The higher the grade, the better the ability to walk
Measured: day 14
arterial blood gas analysis
PH,normal range 7.35-7.45
Measured: day 1
arterial blood gas analysis
PH,normal range 7.35-7.45
Measured: day 7
arterial blood gas analysis
PH,normal range 7.35-7.45
Measured: day 14
partial pressure of carbon dioxide
normal range 35-45 mmHg
Measured: day 1
partial pressure of carbon dioxide
normal range 35-45 mmHg
Measured: day 7
partial pressure of carbon dioxide
normal range 35-45 mmHg
Measured: day 14
oxygenation index
Normal adults are 400,the higher，the better
Measured: day 1
oxygenation index
Normal adults are 400,the higher，the better
Measured: day 7
oxygenation index
Normal adults are 400,the higher，the better
Measured: day 14
lactic acid
normal range 0.5-1.6mmol/L
Measured: day 1
lactic acid
normal range 0.5-1.6mmol/L
Measured: day 7
lactic acid
normal range 0.5-1.6mmol/L
Measured: day 14
Diaphragmatic movement
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Measured: day 1
Diaphragmatic movement
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Measured: day 7
Diaphragmatic movement
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Measured: day 14
Diaphragm contraction rate
Normal adults are 1.3cm/s
Measured: day 1
Diaphragm contraction rate
Normal adults are 1.3cm/s
Measured: day 7
Diaphragm contraction rate
Normal adults are 1.3cm/s
Measured: day 14
Diaphragm thickness at end of breath
Normal adults are 0.15cm
Measured: day 1
Diaphragm thickness at end of breath
Normal adults are 0.15cm
Measured: day 7
Diaphragm thickness at end of breath
Normal adults are 0.15cm
Measured: day 14
Diaphragm thickness at end of inhalation
Normal adults are 0.28cm
Measured: day 1
Diaphragm thickness at end of inhalation
Normal adults are 0.28cm
Measured: day 7
Diaphragm thickness at end of inhalation
Normal adults are 0.28cm
Measured: day 14
Diaphragmatic thickness variation rate
Less than 20% have diaphragmatic dysfunction
Measured: day 1
Diaphragmatic thickness variation rate
Less than 20% have diaphragmatic dysfunction
Measured: day 7
Diaphragmatic thickness variation rate
Less than 20% have diaphragmatic dysfunction
Measured: day 14
E-T index
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
Measured: day 1
E-T index
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
Measured: day 7
E-T index
Product of inspiratory time and diaphragmatic mobility,The higher the extubation success rate, the higher the extubation success rate.
Measured: day 14
Timed Inspiration
Normal adults are 1s
Measured: day 1
Timed Inspiration
Normal adults are 1s
Measured: day 7
Timed Inspiration
Normal adults are 1s
Measured: day 14
Rectus femoris thickness
The thicker the muscle, the better
Measured: day 1
Rectus femoris thickness
The thicker the muscle, the better
Measured: day 7
Rectus femoris thickness
The thicker the muscle, the better
Measured: day 14
Thickness of tibialis anterior muscle
The thicker the muscle, the better
Measured: day 1
Thickness of tibialis anterior muscle
The thicker the muscle, the better
Measured: day 7
Thickness of tibialis anterior muscle
The thicker the muscle, the better
Measured: day 14
Secondary outcomes (6)
Mechanical ventilation time
Mechanical ventilation time
Measured: three months
icu length of stay
icu length of stay
Measured: three months
Time required for independent walking
Time required for independent walking
Measured: three months
delirium
Confusion Assessment Method of the Intensive Care Unit. Positive is delirium.
Measured: 28 days
mortality
mortality
Measured: 28 days
reintubation
Note whether intubation was performed within 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (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
- 50 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
- xin li xie, Principal investigator, The First Medical Center of PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460391
- Sponsor's protocol ID
- Intensive rehabilitation
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early Standing Training on ICU Patients
- ClinicalTrials.gov ID
- NCT04460391
- Acronym / sponsor ID
- Intensive rehabilitation
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 7 Jul 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.
Influence of early standing training on ICU patients
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 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: Intensive rehabilitationEarly standing training and routine rehabilitation |
| control group | Active comparator | Behavioral: Intensive rehabilitationConventional rehabilitation，Muscle training and breathing training |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 |
|---|---|---|
| Intensive rehabilitationEarly standing training and routine rehabilitation | Behavioural | control group, experimental group |
Primary outcome
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.
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.
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.
Berg Balance Scale
Time frame: day 1
Balance grade score,The highest 56 points,The higher the score, the better the balance.
Berg Balance Scale
Time frame: day 7
Balance grade score,The highest 56 points,The higher the score, the better the balance.
Berg Balance Scale
Time frame: day 14
Balance grade score,The highest 56 points,The higher the score, the better the balance.
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.
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.
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.
Holden walk classification
Time frame: day 1
Levels 0 to 5,The higher the grade, the better the ability to walk
Holden walk classification
Time frame: day 7
Levels 0 to 5,The higher the grade, the better the ability to walk
Holden walk classification
Time frame: day 14
Levels 0 to 5,The higher the grade, the better the ability to walk
arterial blood gas analysis
Time frame: day 1
PH,normal range 7.35-7.45
arterial blood gas analysis
Time frame: day 7
PH,normal range 7.35-7.45
arterial blood gas analysis
Time frame: day 14
PH,normal range 7.35-7.45
partial pressure of carbon dioxide
Time frame: day 1
normal range 35-45 mmHg
partial pressure of carbon dioxide
Time frame: day 7
normal range 35-45 mmHg
partial pressure of carbon dioxide
Time frame: day 14
normal range 35-45 mmHg
oxygenation index
Time frame: day 1
Normal adults are 400,the higher，the better
oxygenation index
Time frame: day 7
Normal adults are 400,the higher，the better
oxygenation index
Time frame: day 14
Normal adults are 400,the higher，the better
lactic acid
Time frame: day 1
normal range 0.5-1.6mmol/L
lactic acid
Time frame: day 7
normal range 0.5-1.6mmol/L
lactic acid
Time frame: day 14
normal range 0.5-1.6mmol/L
Diaphragmatic movement
Time frame: day 1
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Diaphragmatic movement
Time frame: day 7
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Diaphragmatic movement
Time frame: day 14
The distance the diaphragm moves downward during inhalation,Normal adults are 1.4cm.
Diaphragm contraction rate
Time frame: day 1
Normal adults are 1.3cm/s
Diaphragm contraction rate
Time frame: day 7
Normal adults are 1.3cm/s
Diaphragm contraction rate
Time frame: day 14
Normal adults are 1.3cm/s
Diaphragm thickness at end of breath
Time frame: day 1
Normal adults are 0.15cm
Diaphragm thickness at end of breath
Time frame: day 7
Normal adults are 0.15cm
Diaphragm thickness at end of breath
Time frame: day 14
Normal adults are 0.15cm
Diaphragm thickness at end of inhalation
Time frame: day 1
Normal adults are 0.28cm
Diaphragm thickness at end of inhalation
Time frame: day 7
Normal adults are 0.28cm
Diaphragm thickness at end of inhalation
Time frame: day 14
Normal adults are 0.28cm
Diaphragmatic thickness variation rate
Time frame: day 1
Less than 20% have diaphragmatic dysfunction
Diaphragmatic thickness variation rate
Time frame: day 7
Less than 20% have diaphragmatic dysfunction
Diaphragmatic thickness variation rate
Time frame: day 14
Less than 20% have diaphragmatic dysfunction
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.
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.
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.
Timed Inspiration
Time frame: day 1
Normal adults are 1s
Timed Inspiration
Time frame: day 7
Normal adults are 1s
Timed Inspiration
Time frame: day 14
Normal adults are 1s
Rectus femoris thickness
Time frame: day 1
The thicker the muscle, the better
Rectus femoris thickness
Time frame: day 7
The thicker the muscle, the better
Rectus femoris thickness
Time frame: day 14
The thicker the muscle, the better
Thickness of tibialis anterior muscle
Time frame: day 1
The thicker the muscle, the better
Thickness of tibialis anterior muscle
Time frame: day 7
The thicker the muscle, the better
Thickness of tibialis anterior muscle
Time frame: day 14
The thicker the muscle, the better
6 secondary outcomes
Mechanical ventilation time
Time frame: three months
icu length of stay
Time frame: three months
Time required for independent walking
Time frame: three months
delirium
Time frame: 28 days
mortality
Time frame: 28 days
reintubation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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. This study is not recruiting at the moment.
xin li xie principal investigator
The First Medical Center of PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intensive rehabilitation in people with Pulmonary Disease, run by Chinese PLA General Hospital.
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 12 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Ying (17600953801 ext. 17600953801, 1412888703@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Research Council (time frame: day 1). The study lists 51 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 7 Jul 2020.