ICU Survivor, Unable to Sit-to-stand
Conditions
Keywords
Sit-to-stand, Functional decline, Intensive care units, Nursing intervention, Randomized controlled trial
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" intervention (STS intervention) and to examine effects of the STS Care in improving ICU survivors' "sit-to-stand" ability, walking independently, physical function, and rates of bed-bound and mortality one year following ICU discharge.
Detailed description
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 stable sitting" or "unable to stable sitting" 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 intervention. The hospital-based (up to 14 days) STS Intervention was provided daily by a independent trained nurse. STS care includes 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 (rate of sit-to-stand, rate of walking independently, FSS-ICU scores, numbers of sit-to-stand repetitions in 30 seconds, MRC scores, 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, rate of bed-bound status, and rate of mortality) was assessed by a blinded research nurse after ICU discharge at 48hours, 14 day, 1, 3, and 12 months. ICU-AW diagnosis (yes or no) at ICU discharge and daily caloric intake were selected a priori as pre-defined covariates and will be included in the analysis.
Interventions
OTHERSit-to-stand Intervention
1. Passive, anti-gravity range of motion(ROM) exercise of lower legs and sitting balance exercise. 2. Sit-to-stand exercise 3. Education on strategies to facilitate sit-to-stand movement and safe transfer
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants who are unable to perform sit-to-stand independently within 48 houre of ICU discharge were enrolled. In the assignment procedure, participants were stratified by "able to stable sitting" or "unable to stable sitting" and then 1:1 randomly assigned to the intervention or usual care groups. Participants in intervention group receive both usual care and an STS care once daily for two workweeks or discharged within two workweeks or death. In contrast, control group will accept usual care. All participants will be assessed at 48 hours,14day, 1, 3, and 12 months following ICU discharge. A comprehensive functional evaluation (rate of sit-to-stand, rate of walking independently, FSS-ICU scores, numbers of sit-to-stand repetitions in 30 seconds, MRC scores, muscle strength at knee extensors, ADL, and IADL) and rates of bed-bound status and mortality will be assessed by a outcome assessor.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 20 years or older. * Admitted to ICU \> 2 days. * Being unable to sit to stand independently at ICU discharge.
Exclusion criteria
* Could not follow instructions * Bedridden before index hospitalization. * Ventilator use after ICU discharge . * Received palliative care. * had pre-existing neurological or musculoskeletal conditions that made sit-to-stand impossible (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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand independently | Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge. | Participants are able to sit to stand independently, allowed armrest use |
| FSS-ICU scores | Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge. | The FSS-ICU use 7-points score to evaluated 5 functional tasks, which includes rolling, supine-to -sit transfer, unsupported sitting, sit-to-stand transfer, and ambulation. Score range from 0 to 35, higher score indicated better physical performance. Walking independently will be analyzed. |
| Modified 30-second sit-to-stand test | 14day, 1, and 3 months after ICU discharge. | Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds, alowed armrest used. |
| Muscle strength(kg) at knee extensors | Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge | Measured by Hoggan MicroFET®2 in kg |
| MRC scores | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge | Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel index for activities of daily living (ADL) | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge. | Measured by ADL in score, range from 0-100 score, higher score indicated health condition |
| Instrumental activities of daily living scale (IADL) | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge. | Measured by IADL in score, range from 0 to 8 score, higher score indicated better health condition |
| Rate of bed-bound status | 1, 3, and 12 months after ICU discharge. | Obtained by family interview and medical record |
| Rate of mortality | 1, 3, and 12 months after ICU discharge. | Obtained by family interview and medical record |
| The 6 minute walk test | 3 and 12 months after ICU discharge. | Measured by walked distance in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition |
Countries
Taiwan
Outcome results
None listed