Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors
NCT ID: NCT04640441
Last Updated: 2025-11-18
Study Results
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Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2020-09-14
2024-11-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Participants in the control group received usual care.
No interventions assigned to this group
Sit-to-stand care group
Intervention was provided once daily by trained nurses for a maximum of 14 days or until hospital discharge or death.
Sit-to-stand care
1. Passive range of motion(ROM) exercise of lower legs, active ROM exercise of lower legs, and sitting balance exercise, 20\~30 min, once daily.
2. Anti-gravity ROM exercise of lower leg, resistance exercise of low leg, and sitting balance exercise, 20\~30min, once daily.
3. Stepping exercise and sit-to-stand exercise, 20\~30min, once daily.
Interventions
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Sit-to-stand care
1. Passive range of motion(ROM) exercise of lower legs, active ROM exercise of lower legs, and sitting balance exercise, 20\~30 min, once daily.
2. Anti-gravity ROM exercise of lower leg, resistance exercise of low leg, and sitting balance exercise, 20\~30min, once daily.
3. Stepping exercise and sit-to-stand exercise, 20\~30min, once daily.
Eligibility Criteria
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Inclusion Criteria
* Admitted for ICU treatment \> 2 days.
* Unable to sit-to-stand by ICU discharge.
Exclusion Criteria
* 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 )
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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Cheryl, Chia-Hui Chen, PhD
Taipei, National Taiwan University Hospital, Taiwan
Countries
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References
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Other Identifiers
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202007109RINB
Identifier Type: -
Identifier Source: org_study_id
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