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临床试验/NCT05039879
NCT05039879已完成不适用

Life Improving Factors After a Hip Fracture

Wageningen University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Protein intake

研究概览

简要总结

The primary objective of the proposed research is to investigate the association between protein intake and nutritional status with bone health and physical functioning in older hip fracture patients. In addition, it will be investigated which patient characteristics and modifiable factors can predict mobility, clinical frailty, living situation and mortality. This study will be a 3-month prospective cohort study in adults aged 70 years and older with an acute hip fracture. This study will lead to knowledge about how protein intake and nutritional status in combination with patient characteristics can predict the degree of recovery (bone health and physical functioning) 3 months after the hip fracture. Knowledge on factors related to recovery can contribute to an improved and shorter rehabilitation in the future, which results in a reduction of health care costs.

详细描述

Only half of the patients with an acute hip fracture regain their pre-fracture functional level and 24% dies within the following year. Identifying and targeting modifiable risk factors for optimal recovery after a hip fracture is therefore essential. These factors include protein intake and nutritional status, which may affect markers of bone health and physical functioning and thereby influence recovery.

Measurements will be performed at baseline (within 5 days after the hip surgery) and after 3 months during an outpatient clinic visit for the evaluation of the hip fracture surgery. A total of 95 older adults (aged 70 years or older) recovering from an acute hip fracture will be recruited from Rijnstate hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 70 years
  • Community-dwelling
  • Proximal femur fracture: femoral neck fracture/ pertrochanteric fracture, subtrochanteric fracture
  • Able to give informed consent
  • Pre-fracture Clinical Frailty Scale 3-6

排除标准

  • Pathological fracture or periprosthetic fracture
  • Current participation in scientific research that interferes with the proposed study
  • History of dementia
  • No permission to request information from the general practitioner/ treating specialist(s) about medical history, medication use, liver and kidney values, and details about the broken hip

结局指标

主要结局

Protein intake

时间窗: Three months

Dietary protein intake will be recorded using a protein screener which gives an indication of protein intake in g/d. Based on the past 4 weeks.

Procollagen type 1 N propeptide

时间窗: Three months

Bone turnover marker, in serum

Nutritional status

时间窗: Three months

Using the Mini Nutritional Assessment Short Form. Subjects will be classified as having a normal nutritional status (12-14 points), having a risk of malnutrition (8-11 points), or being undernourished (0-7 points).

C-terminal telopeptide of type I collagen

时间窗: Three months

Bone turnover marker

Calcaneus quantitative ultrasound parameters

时间窗: Three months

Ultrasound of the calcaneus which gives an indication of the bone density. Device yields the following two parameters: speed of sound (SOS) and broadband ultrasound attenuation (BUA), which can be combined to get the Stiffness Index (SI).

Insulin-like growth factor 1

时间窗: Three months

In serum

Parathyroid hormone levels

时间窗: Three months

In serum

Grip work

时间窗: Three months

Using the Martin vigorimeter

Handgrip strength

时间窗: Three months

Using the Martin vigorimeter

次要结局

  • Bodyweight(Three months)
  • Mobility(Three months)
  • Frailty(Three months)
  • Appendicular skeletal muscle mass(Three months)
  • Barthel Index(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugo Wijnen

Drs.

Rijnstate Hospital

研究点 (1)

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