Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
试验速览
- 阶段
- 3 期
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- rate of falls compared between treatment arms
研究概览
简要总结
The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.
The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.
详细描述
Subjects:
The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who reach a Folstein Mini Mental Status of less than 15 are excluded.
Design:
Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy. Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.
Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
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
- •Age 65 years or older
- •Acute hip fracture admitted to one hospital center
排除标准
- •A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
- •Primary hyperparathyroidism
- •Current cancer with wasting or bone metastases
- •Hyperparathyroidism
- •Sarcoidosis
- •A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
- •Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
- •non-surgical treatment
- •no German language skills
- •severe hearing or visual impairment
结局指标
主要结局
rate of falls compared between treatment arms
次要结局
- low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
- number of persons who fell
- quality of life (Euro-Qol)
- health care utilization
- rate of injurious falls
- disability
- mortality
- admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture