Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors

Study Overview
=================
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.

Official Title
-----------------
Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors: A Randomized Controlled Trial

Conditions
-----------------
Unable to Sit-to-stand, ICU Survivor

Intervention / Treatment
-----------------
* Other: Sit-to-stand care


Participation Criteria
=================
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 )

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants in the control group received usual care. | |
| Experimental: Sit-to-stand care group<br>Intervention was provided once daily by trained nurses for a maximum of 14 days or until hospital discharge or death. | Other: Sit-to-stand care<br>* Passive range of motion(ROM) exercise of lower legs, active ROM exercise of lower legs, and sitting balance exercise, 20 30 min, once daily. Anti-gravity ROM exercise of lower leg, resistance exercise of low leg, and sitting balance exercise, 20 30min, once daily. Stepping exercise and sit-to-stand exercise, 20 30min, once daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit-to-stand independently (percent) | Evaluated by one successful and independent sit-to-stand, allowed armrest use | Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge. | 
| scores of FSS-ICU | 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. | Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge. | 
| scores of MRC muscle scale | Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge. | 
| muscle strength(kg) at knee extensors | Measured by Hoggan MicroFET®2 in kg | Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge. | 
| 30-second sit-to-stand test | Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds | 14day, 1, and 3 months after ICU discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index for activities of daily living (ADL) | Measured by ADL in score, range from 0-100 score, higher score indicated health condition | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge. | 
| Instrumental activities of daily living scale (IADL) | Measured by IADL in score, range from 0 to 8 score, higher score indicated better health condition | Baseline within 48 hours. 1, 3, and 12 months after ICU discharge. | 
| Rate of bed-bound status (percent) | Obtained by family interview and medical record | 1, 3, and 12 months after ICU discharge. | 
| Rate of mortality (percent) | Obtained by family interview and medical record | 1, 3, and 12 months after ICU discharge. | 
| The 6 minute walk test | Measured by walked distance in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition | 3 and 12 months after ICU discharge. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sit-to-stand, Functional decline, Intensive care units, Nursing intervention, Randomized controlled trial