Clinical trial NCT04640441: Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors
Official title: Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unable to Sit-to-stand
ICU Survivor
Keywords: Sit-to-stand
Functional decline
Intensive care units
Nursing intervention
Randomized controlled trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 273
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who were screened as failure to sit-to-stand after discharged from medication ICU 48 hours were enrolled in the study. In the assignment procedure, participants were stratified by "able to remain sitting upright without falling" or "unable to remain sitting upright" and then 1:1 randomly assigned to the intervention or usual care groups. Participants in intervention group received both usual care and an STS care once daily for two weeks or discharged within two weeks or death. In contrast, control group will accept regular care. Participants were followed for one year after ICU discharge at 5 point:48 hours, 14day, 1, 3, and 12 months. A comprehensive functional evaluation (success rate of sit-to-stand, scores of FSS-ICU, scores of MRC scale, muscle strength at knee extensors, scores of barthel index for ADL, scores of IADL, walking distance by 6-minute walk test, numbers of sit-to-stand repetitions in 30 seconds) and rates of bed-bound status and mortality were performed.
Primary purpose: TREATMENT

Brief summary: "Sit-to-stand" is key to independent living. For intensive care unit (ICU) survivors, failure to perform sit-to-stand results in bed-bound status, unable participating in important activities of daily living (ADLs) or instrumental ADLs. Recent studies indicated that 31% of ICU survivors remained bed-bound and unable to "sit-to-stand" after returning home. Our preliminary findings further indicated that 70% of ICU survivors who had the ICU-acquired weakness (ICU-AW) were unable to "sit-to-stand" one-month after ICU discharge.

The aim of this 3-year research project was to develop a feasible and effective "sit-to-stand" care (STS Care). A randomized controlled trial (RCT) design is proposed to examine effects of the STS Care in improving ICU patients' "sit-to-stand" ability, physical function, and rates of bed-bound and mortality one year following ICU discharge.

The trial was approved by the Human Research Ethics Committee at the study site before enrollment. Adult ICU patients (≥ 20 years) admitted consecutively to six medical ICUs of a university affiliated medical center was eligible for the study if they were unable to "sit-to-stand" independently at ICU discharge. Upon signing informed consent, participants will be first stratified by "able to remain sitting upright without falling" or "unable to remain sitting upright" and then randomized separately into the intervention or usual care groups, according to computer-generated randomization tables. Participants in the intervention group received both usual care and the STS Care.

The hospital-based (up to 14 days) STS Care, which was provided daily by the same trained nurse, consisted of nurse-supervised anti-gravity and resistant exercise (intensity based on patients' tolerance), repetitive sit-to-stand practice, and advice on sit-to-stand strategies. A comprehensive functional evaluation (success rate of sit to stand, scores of FSS-ICU, scores of MRC muscle scale, muscle strength at knee extensors, scores of the barthel index for activities of daily living (ADL), scores of instrumental activities of daily living scale (IADL), the walking distance by the 6-minute walk test, numbers of sit-to-stand repetitions in 30 seconds, rate of bed-bound status, rate of mortality) was assessed by blinded research nurses after ICU discharge at 5 time points:48hours, 14 day, 1, 3, and 12 months.

Detailed description: For this stratified randomization and single blinding study, participants (≧20 years) who are screened with failed sit-to-stand ability after discharged from the National Taiwan University Hospital medication ICU 48hours will be enrolled in the study. In the assignment procedure, the participants will be stratified by a stabilized sitting posture and unable stabilized sitting posture, and then the participants are randomized to the experiment group and control group. The experiment group will accept regular care and an extra STS bedside care protocol once a day for two weeks or discharged within two weeks. In contrast, the control group will accept regular care.

All participants will be followed for one year after ICU discharge at 5 time points:48 hours, 14day,1, 3, 12 months. A comprehensive functional evaluation (success rate of sit to stand, scores of FSS-ICU, scores of MRC muscle scale, muscle strength at knee extensors, scores of the barthel index for activities of daily living (ADL), scores of instrumental activities of daily living scale (IADL), the walking distance by the 6-minute walk test, numbers of sit-to-stand repetitions in 30 seconds, rate of bed-bound status, rate of mortality) will be performed. Estimated 206 participants will be enrolled and followed one year after ICU discharge.

Eligibility criteria: Inclusion Criteria:

* Age 20 years or older.
* Admitted for ICU treatment \> 2 days.
* Unable to sit-to-stand by ICU discharge.

Exclusion Criteria:

* Unable to follow command.
* Bedridden before index hospitalization.
* Ventilator dependent after ICU discharge .
* Received palliative care.
* Co-morbidities of the trunk or lower limbs unable to ambulate due to neuromuscular or musculoskeletal etiology (e.g. CVA, spinal cord injury, amputation or fracture of lower limb).
* Placed on droplet or contact precausion (e.g. Open TB, SARS, COVID-19 )

Primary outcomes:
measure: Sit-to-stand independently (percent)
timeFrame: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
measure: scores of FSS-ICU
timeFrame: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
measure: scores of MRC muscle scale
timeFrame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
measure: muscle strength(kg) at knee extensors
timeFrame: Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge.
measure: 30-second sit-to-stand test
timeFrame: 14day, 1, and 3 months after ICU discharge.
Secondary outcomes:
measure: Barthel index for activities of daily living (ADL)
timeFrame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
measure: Instrumental activities of daily living scale (IADL)
timeFrame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
measure: Rate of bed-bound status (percent)
timeFrame: 1, 3, and 12 months after ICU discharge.
measure: Rate of mortality (percent)
timeFrame: 1, 3, and 12 months after ICU discharge.
measure: The 6 minute walk test
timeFrame: 3 and 12 months after ICU discharge.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheryl, Chia-Hui Chen, PhD
state: National Taiwan University Hospital
Study officials:
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