NCT04760392已完成不适用
Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from baseline of the DEMMI score
研究概览
简要总结
Immobilization in general internal medicine inpatients is a major contributor to morbidity and mortality. Goal-directed mobilization (GDM) may improve mobility. The aim of this study is to assess, if GDM increases physical activity (DEMMI score) during hospitalization and improves quality of care until 3 months after hospitalization.
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
- •All consenting patients aged ≥ 18 years admitted to the Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, who have an indication for physiotherapy (prescription by the resident in charge or the care coordinator).
- •Participants must be randomized at latest on the second day after hospital admission.
- •Written informed consent.
排除标准
- •Inability to follow study procedures, i.e., due to language problems (unable to read, speak or understand German), psychological disorders, severe dementia (defined as to levels 5 - 7 in the Global Deterioration Scale), blindness, Patients unable to provide informed consent themselves
- •Expected hospital stay for < 5 days
- •Medically indicated bedrest for more than 24 h, e.g. after surgery
- •Injuries or neurologic deficits of one or both lower extremities directly impairing walking capacity (e.g. fractures, hemiplegia, previous use of a wheelchair or bedriddenness)
- •Terminal illness
- •Pregnancy or breast feeding
- •Previous enrolment in this study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Change from baseline of the DEMMI score
时间窗: Day 5±2
Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist
次要结局
- Length-of-hospital-stay(3 months)
- Number of delirium episodes(During hospitalization (max. 14±2 days))
- Total number of falls (with / without injuries)(3 months after study inclusion)
- Destination(3 months after study inclusion)
- Number of in-hospital falls(During hospitalization (max. 14±2 days))
- Independence during activities of daily living: change in Barthel index between (German version)(3 months after study inclusion)
- Change from baseline of the DEMMI score(Hospital discharge (max. day 14±2))
- Mobilization time(During hospitalization (max. 14±2 days))
- Reaching MCID(Hospital discharge (max. day 14±2))
- Number of re-hospitalizations and all-cause mortality(3 months after study inclusion)
- Concerns of falling: change in Falls Efficacy Scale - International (FES-I, German version)(3 months after study inclusion)
- Quality of life: change in EuroQol (EQ-5D-5L, German version)(3 months after study inclusion)
研究者
研究点 (2)
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