An interventional study of Early multicomponent physical therapy program in Sepsis, sponsored by Zhujiang Hospital. Status unknown. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Zhujiang Hospital · Not applicable, Interventional, and Prevention
Among 11 studies in Sepsis by Zhujiang Hospital — 4 open to participants now, 4 under way, none of them phase 3. Sepsis · Zhujiang Hospital.
Among the 11 studies in Sepsis by Zhujiang Hospital, this one is the only one that started in 2018, is one of 2 with no phase, and was the 2nd registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →4 of the 11 studies in Sepsis by Zhujiang Hospital are open now, in 1 country. Recruiting first, the newest first:
Zhujiang Hospital · Sites in China
Ages 18+ · Healthy volunteers
Zhujiang Hospital · Sites in China
Ages 18–80
Zhujiang Hospital · Sites in China
Ages 18–80
Zhujiang Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 16 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4
First in 2017; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 800 is above the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 117 across the 6 interventional studies, 216 across the 5 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Zhujiang Hospital is the lead sponsor of 202 studies on the registry; 96 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Sepsis by Zhujiang Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.
The study is a prospective, multi-center, assessor-blinded, randomized controlled trial and will be conducted in 9 medical ICUs at 7 tertiary hospitals in Southern China. Mechanically ventilated septic patient admitted into ICU will be screened for eligibility into the study. When medically stable, patients randomize into the intervention group will receive a multi-component PT. The PT program is designed to counteract ICUAW, delirium, DD and acute GI injury, and consists of 5 consecutive sessions including positioning, extremities muscle strength training, respiratory muscle strength training, neuromuscular electrical stimulation (NMES) and gut rehabilitation. Each PT session will last for 30 minutes and be provided once daily, 5 days per week, and tailored for each individual subject. PT intervention will continue throughout patient's ICU stay or the primary endpoint is reached. The primary outcome will be the ICU 28-day all-cause mortality, and the secondary outcome measures, e.g., incidences or duration of ICUAW, delirium, DD and acute GI injury, mechanical ventilation outcomes (ventilator dependence, ventilator-free days), adverse events, restoration to independent functional status and long-term survival, will be assessed at preset time points of interviews during periods of treatment and 1-year follow-up after discharge from hospital. The total in-hospital and re-hospitalization costs in the intervention group will be also analyzed and compared to control group to assess the cost-effectiveness of the rehabilitation program.To our knowledge, this study is the first randomized controlled trial examining the efficacy and safety of a multi-component PT program in critically ill sepsis patients on ventilator. Given that rehabilitation is not a routine therapy across most ICUs in China, If this PT program is found to be of mortality benefit, it will provide an alternative non-pharmaceutical approach to deal with these lethal ICU-related complications and reduce the subsequent death. It will also provide useful information for clinical decision and local medical policies making, as well as identifying sepsis patient population who might best benefit from early rehabilitation program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early multicomponent physical therapy program plus sepsis standard therapy
Other: Early multicomponent physical therapy program
Sepsis standard therapy, including early initiation of intravenous antibiotics, infection source debriding, appropriate fluid therapy, minimum sedation, protocolized weaning procedure, blood glucose control and early enteral feeding, etc.
1. Positioning (upright bed standing; turning, moving on bed). 2. Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling). 3. Respiratory muscle training (supine abdominal breathing training). 4. Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris). 5. Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage).
ICU 28-day mortality
Sepsis or non-sepsis related death, undetermined cause of death.
Time frame: Through 28-day study period in the ICU.
Incidence of ICU-required weakness
Using the Medical Research Council (MRC) Score for Muscle Strength to test 12 muscle groups in upper extremities (wrist flexion, elbow flexion, shoulder abduction) and lower extremities (dorsiflexion, knee extension, hip flexion). The MRC sum score ranges from 0 (complete paralysis) to 60 (full strength) as determined by manual muscle testing (MMT), which grades muscle strength from 0 (paralysis) to 5 (normal muscle strength) in each muscle group tested. Patient with a MRC sum score of \< 48 or a mean MRC score of \< 4 per muscle group will be considered to have ICUAW. If measurement is impossible at recruitment, patient will be deemed as without ICUAW by a Barthel Index score \> 60, which ranges from 0 (complete dependence) to 100 (complete independence), collected from a proxy reflecting baseline independent functional status 2 weeks prior to critical illness.
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of delirium
Acute cerebral dysfunction with altered mental status, inattention, and either disordered thinking or an altered level of consciousness as determined by the Confusion Assessment Method for the ICU (CAM-ICU). If assessment is impossible at recruitment, patient will be considered without delirium by absence of a history of insanity collected from a proxy reflecting baseline mental status 2 weeks prior to critical illness.
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Incidence of diaphragmatic dysfunction
Maximum negative inspiratory pressure (PImax) less than - 80 cm H2O is usually considered to have clinically important inspiratory muscle weakness. Measurements will be performed by using inspiratory hold key on ventilator (intubated patient) or a one-way exhalation valve placed on the opening of mouth (extubated patient). Patient will be instructed to perform maximal inspiratory efforts for 20 seconds against occluded airway at functional residual lung volume (FRC), and change in pressure be recorded by an external data acquisition system (Powerlab/16sp ML795, Australia ADInstruments) through a physiological pressure sensor (MLT 844, Australia ADInstruments) connected to the opening of endotracheal tube or the valve. The signal sampling frequency will be set at 100 Hz and low-pass filtering frequency at 20 Hz. The signal collected will be digitalized and analyzed in a manner of time-domain, and the PImax be recorded after 3 repetitions.
Time frame: Assessed on the day of first try to wean from ventilator, repeated on the days of ICU discharge and hospital discharge, with an average of 1 month.
Incidence of acute gastrointestinal injury
Malfunctioning of the GI tract in critically ill patients due to their acute illness, distinguished and graded by severity of GI symptoms (e.g., feeding intolerance, vomiting, diarrhoea, paralysis, high gastric residual volumes (HGRVs). Acute gastrointestinal injury (AGI) grade I: increased risk to develop GI dysfunction or failure; AGI grade II: GI dysfunction (interventions required); AGI grade III: GI failure (GI function cannot be restored with interventions); AGI grade IV: dramatically manifesting GI failure.
Time frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.
Ventilator dependence
Referred to one of the following categories: difficult weaning: fail initial weaning and require up to 3 spontaneous breath test (SBT) or ≤7 days to achieve success; delayed weaning: fail at least 3 weaning attempts or require \> 7 days to weaning after the first SBT; prolonged mechanical ventilation (PMV): requiring ventilator support for more than 21 days.
Time frame: Number of days required to weaning after the first try, number of days on ventilator, assessed within an average of 3 weeks.
Adverse events
Unexpected physiologic response or patient complaints to physical exercise, e.g., more than 20% variability in rest heart rate; 110 mmHg \< mean arterial pressure \< 60 mmHg; decremental pulse oximetry \< 90%; severe dyspnea as determined by the Modified Borg Dyspnea Scale \> 4 (ranged from 0-10, indicative of dyspnea degree from just noticeable to maximum); patient-ventilator asynchrony; altered mentation; catheters or tubes displacement; documented organ damage; accidental death.
Time frame: Through physical therapy periods, an average of 1 month.
Length of stay
Number of days spent in the ICU or hospital.
Time frame: From admission to ICU discharge and hospital discharge, estimated between 4 to 6 weeks.
Independent functional status
Referred to ability to perform 10 activities of daily living (ADL's), including eating, transfer from bed to chair, dressing, toileting, bathing, grooming, walking, stair climbing, maintaining continence. Independent functional status is determined by a Barthel Index Score \> 60, which ranged from 0 (complete dependence) to 100 (complete independence).
Time frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
Health-related quality of life (HRQOL)
Evaluated by using the mandarin version Short-Form-36 Questionnaire translated by the Zhejiang University, China., consisting of eight domains (e.g., physical function (PF), role limitations due to physical problems (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role limitations due to emotional problems (RE), mental health (MH). The combined score for each domain is obtained by summing score of each item contained in the domain and directly converted into a 0-100 score scale using the Likert method of summated ratings. A score scale of zero is equivalent to maximum disability and 100 equals to the best possible health state.
Time frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge.
One-year mortality
All-cause death during 1-year follow-up after hospital discharge.
Time frame: One year.
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Mar 2018; primary completion for Dec 2020, 33 months later.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 33 months is above that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.