The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Occurrence of intensive care unit-acquired weakness (ICUAW)
研究概览
简要总结
This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Being mechanically ventilated ≥ 24 hours
- •Richmond Agitation-Sedation Scale (RASS): 0 to -1
- •No vision, hearing, or body movements restriction
- •With clear consciousness and ability to communicate in Chinese
- •Expected to stay in the ICU > 96 hours.
排除标准
- •Have developed delirium before enrollment (ICDSC > 4)
- •With acute physiology and chronic health evaluation (APACHE II) score > 25 after ICU admission within 24 hours
- •With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.
研究组 & 干预措施
Usual care group
Participants in the usual care group will receive routine rehabilitation treatment.
Technology-assisted early mobilization group
Participants in the technology-assisted early mobilization group will receive protocol-oriented early mobilization program and technology-assisted, family-engaged in-bed activities within 72 hours of ventilator use.
干预措施: Technology-assisted, family-engaged in-bed activities (Other)
Technology-assisted early mobilization group
Participants in the technology-assisted early mobilization group will receive protocol-oriented early mobilization program and technology-assisted, family-engaged in-bed activities within 72 hours of ventilator use.
干预措施: Protocol-oriented early mobilization program (Other)
Systematic early mobilization group
Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use.
干预措施: Protocol-oriented early mobilization program (Other)
结局指标
主要结局
Occurrence of intensive care unit-acquired weakness (ICUAW)
时间窗: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
The occurrence of ICUAW will primarily be assessed using the Medical Research Council (MRC) scale. An MRC sum score of less than 48 indicates the presence of ICUAW.
次要结局
- psychological distress(On the day of enrollment, ICU discharge (or up to 28 days after enrollment), on the day of hospital discharge (expected up to 3 month), and six-month after hospital discharge.)
- Muscle power(On the day of enrollment and ICU discharge (or up to 28 days after enrollment).)
- Hand-grip strength(On the day of enrollment and ICU discharge (or up to 28 days after enrollment).)
- Delirium(Through intervention completion, up to 28 days.)
- Subjective sleep status(Through intervention completion, up to 28 days.)
- Objective sleep status(Through intervention completion, up to 28 days.)
- Functional Status(On the day of enrollment and ICU discharge (or up to 28 days after enrollment).)
- Duration of ventilation use(On the day of hospital discharge (expected up to 3 month).)
- Length of stay in the ICU(On the day of hospital discharge (expected up to 3 month).)
- Length of stay in the hospital(On the day of hospital discharge (expected up to 3 month).)
- Adverse event(Through intervention completion, up to 28 days.)
- Activities of daily living (ADL)(On the day of ICU discharge (up to 28 days after enrollment), hospital discharge (expected up to 3 month), and six-month after hospital discharge.)
- Sleep quality(On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.)
- Quality of life (QoL)(On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.)
研究者
Hsiao-Yean Chiu
Professor
Taipei Medical University