ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 488
- 试验地点
- 2
- 主要终点
- Change from baseline Barthel Index 100
研究概览
简要总结
This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Design: blinded RCT. Patients: n = 488. Primary outcome is functional decline, assessed by Barthel-Index and 30s chair stand test. One- and three months follow-up.
详细描述
Introduction:
Inactivity during hospitalisation is associated with significant risk of functional decline especially in older patients. This have major impact on the individual level due to decreased wellbeing and higher level of dependency and on the society level due to increased caregiver burden following hospital discharge. This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Methods:
ROBUST is a blinded RCT. Patients (n = 488) admitted with acute medical illness to Department of Geriatric Medicine, Odense University Hospital will be randomised to usual care and robot assisted active strength training of lower extremities twice daily (intervention group) or usual care and robot assisted passive sham training (control group) until discharge. Both groups will receive protein supplements.
Inclusion criteria: ≥65 years of age, able to ambulate before hospitalisation, expected length of stay ≥2 days.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥65 years of age
- •Able to ambulate before hospitalisation (with/without assistance)
- •Able to communicate with the research team
- •Expected length of stay ≥2 days
- •Residing on Funen, Denmark
排除标准
- •Able to ambulate without assistance during current hospitalisation
- •Known severe dementia
- •Positive Confusion and Assessment Method score (20)
- •Patients who have received less than 3 training sessions at discharge
- •Terminal illness
- •Recent major surgery or lower extremity bone fracture in the last 3 months
- •Conditions contradicting use of ROBERT (unstable vertebral-, pelvic, or lower extremity fractures; high intracranial pressure; pressure ulcers or risk of developing pressure ulcers due to fragile skin; patients with medical instability)
- •Metastases at femur or hip
- •Deemed not suitable for mobilization sessions with the robot by the healthcare professional
- •If the patient weighs more than 165 kg (the robot cannot lift the leg if the patient is severely overweight)
结局指标
主要结局
Change from baseline Barthel Index 100
时间窗: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Functional evaluation assessed by Barthel Index 100. The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Change from baseline 30 Second Sit to Stand Test
时间窗: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Functional evaluation assessed by 30 Second Sit to Stand Test . The 30 Second Sit to Stand Test is for testing leg strength and endurance in older adults.
次要结局
- Length of hospital stay(From day of hospital admission to day of hospital discharge (an average of 1 week).)
- Health care cost evaluation(3 months follow-up.)
- Change from baseline 30 Second Sit to Stand Test(Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.)
- Sarcopenia(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
- Discharge destination(Day of hospital discharge (an average of 1 week).)
- Quality of life EQ-5D(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
- Muscle quantity(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
- Cognitive function(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
- Need of care at home(From 3 months prior to day of hospital admission to 3 months following day of hospital discharge.)
- Rate of hospital readmission(30 days following day of hospital discharge.)
- Patient perspective by qualitative interviews(Day of hospital discharge (an average of 1 week); 1 month follow-up.)
- Mortality(1- and 3-months follow-up.)
- Clinical Frailty Scale(Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.)
- Concern about falling including number of falls(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
- Change from baseline Barthel Index 100(Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.)
- Mood status(Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.)
研究者
Jesper Ryg
Professor, Consultant, MD
Odense University Hospital