Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Sit-to-stand independently (percent)
研究概览
简要总结
"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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older.
- •Admitted to ICU > 2 days.
- •Being unable to sit to stand independently at ICU discharge.
排除标准
- •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 )
研究组 & 干预措施
Sit-to-stand care group
Intervention was provided once daily by trained nurses for a maximum of 2 workweeks or until hospital discharge or death.
干预措施: Sit-to-stand Intervention (Other)
Control group
Participants in the control group received usual care.
结局指标
主要结局
Sit-to-stand independently (percent)
时间窗: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
Evaluated by one successful and independent sit-to-stand, allowed armrest use
scores of MRC muscle scale
时间窗: 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
scores of FSS-ICU
时间窗: 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.
muscle strength(kg) at knee extensors
时间窗: Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge.
Measured by Hoggan MicroFET®2 in kg
30-second sit-to-stand test
时间窗: 14day, 1, and 3 months after ICU discharge.
Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds
Sit-to-stand independently
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge
Measured by Hoggan MicroFET®2 in kg
MRC scores
时间窗: 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
次要结局
- Instrumental activities of daily living scale (IADL)(Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.)
- Rate of mortality (percent)(1, 3, and 12 months after ICU discharge.)
- The 6 minute walk test(3 and 12 months after ICU discharge.)
- Barthel index for activities of daily living (ADL)(Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.)
- Rate of bed-bound status (percent)(1, 3, and 12 months after ICU discharge.)
- Rate of bed-bound status(1, 3, and 12 months after ICU discharge.)
- Rate of mortality(1, 3, and 12 months after ICU discharge.)