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临床试验/NCT02780076
NCT02780076Unknown不适用

Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly

Vestre Viken Hospital Trust2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年5月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
Change in the performance-based Short physical performance battery (SPPB)

研究概览

简要总结

The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.

详细描述

Functional training, such as walking and transfers, ought to be an important part of the rehabilitation after hip fracture. We have an assumption that it is of utmost importance to continue and progress the functional training that started in the acute phase at the hospital, also during the sub-acute phase while the patients are at short-term stays in nursing homes. However, there are indications of lack of resources in the nursing homes and that the nurses may be less concerned with their role and participation in the patients' rehabilitation process. Possibly, this creates a discontinuity in the rehabilitation efforts during short-term stays that may have a negative impact on the patients' recovery of physical functioning.

In this study the aim is to continue and progress the functional training started during hospital stay, such as training in walking and further on repetitive sit-to-stands, as part of the daily habitual routine during short-term stays in the nursing homes. This type of functional training may be motivational and easily recognizable to the patients, and it can also be carried out by the nursing staff with only initial guiding from a physiotherapist. There is lack of knowledge on the effect of additional functional training, incorporated as part of the habitual daily routine during short-term stays, on the patients' immediate and long term recovery of physical functioning and activity level after hip fracture, compared to usual care alone.

The study is designed as a single-blind randomized controlled trial (RCT), comparing the effects of additional functional training (functional training group)to usual care alone (control group) during short-term stays in nursing homes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients with an acute low-energy hip fracture (intracapsular, trochanteric or subtrochanteric) and treated surgically, ≥ 65 years of age, living in their own homes prior to the fracture, and able to give an informed consent.

排除标准

  • Patients unable to walk 10 meters with or without a walking aid prior to the fracture, have a score of less than 15 points on Minimal Mental Status Evaluation (MMS-E) in the acute phase, have a pathological fracture, life expectancies of less than three months, medical contraindications for training, or are incapable of understanding and speaking the Norwegian language.

结局指标

主要结局

Change in the performance-based Short physical performance battery (SPPB)

时间窗: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery

Measurement of physical functioning

次要结局

  • Change in the performance-based measure Timed Up & Go (TUG)(Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
  • Change in the performance-based measure Hand grip strength(Change 5 days - 12 months)
  • New Mobility Scale (NMS)(Change 5 days - 12 months after surgery)
  • Pain in rest and while walking(Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
  • EuroQol (European quality of life) health status measure(Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
  • Walking Habits(Change 5 days - 3 months, change 5 days - 12 months after surgery)
  • Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)(Descriptive from day 5 to 19 after surgery)
  • University of California Los Angeles (UCLA) activity scale(Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months)
  • Fall efficacy scale (FES)(Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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