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临床试验/NCT06700031
NCT06700031尚未招募不适用

Time on Feet After Hip Fracture Event - the TOFFEE Study

Region Skane1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Region Skane
入组人数
40
试验地点
1
主要终点
Minutes in upright position per day

研究概览

简要总结

With simple technology investigators can map how long it takes for a patient with a hip fracture to be helped and encouraged to stand and walk in the days following the injury. A small sensor on the thigh can measure advanced data regarding movement patterns. The limited research results available show that patients spend too much time lying down or sitting, which can lead to poorer recovery, complications, and an increased risk of death. The project maps the current situation in orthopedic emergency care as well as in orthopedic geriatric care, which is provided in a modern building with single rooms and private bathrooms. In addition to better understanding the significance of different care models, the project aims to present baseline data that future intervention studies can use as control material. The project will also connect the activity level of the patients during the hospital stay with ongoing rehabilitation studies in community follow-up care.

详细描述

Purpose and Specific Objectives Can better diagnosis and prevention of inactivity after hip fractures improve outcomes for individuals and society? The goal is to measure how much individuals with hip fractures move during their hospital stay, to investigate the link between activity levels and complications such as thromboembolism, infections, and mortality, and to use inertial measurement units (IMU) to provide feedback to patients and healthcare providers.

Outcomes after frailty-related fractures remain poor, despite improved orthopedic surgical treatment. Every year, at least 50,000 people over the age of 65 in Sweden sustain a major fracture. Despite enhanced treatment and care, a fracture in older individuals often leads to permanent reductions in function and quality of life. Hip fractures are also associated with an increased risk of death. In addition to personal consequences, the many fractures have significant effects on healthcare and social elder care. Relatives are also affected. Falls are estimated to cost society over 14 billion kronor annually.

To improve recovery and avoid complications after a fracture, coworkers must think broadly and innovatively in healthcare. Given the rapid changes in lifestyle and socioeconomics, it is questionable whether healthcare providers can apply research findings based on previous generations to today's older adults, for example concerning physical activity.

A hip fracture is surgically treated so that the skeleton can withstand immediate weightbearing. However, patients spend too much time immobilized, according to the limited research available. This inactivity can lead to limited recovery, complications such as infections and thromboembolism, longer hospital stays, and an increased risk of death.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Having an acute hip fractures and being admitted to either two wards with orthopedic standard care or to one with orthogeriatric care at Skane University Hospital, Malmö

排除标准

  • Lack of standing ability prior to the fracture, defined as requiring a sling lift for transfer
  • Skin disease that prevent the sensor from being attached (dry, flaky, or sore skin, or sensitivity to adhesive)
  • Additional fractures besides the hip fracture or other injuries that reduce mobility (e.g., head or thoracic injuries)

结局指标

主要结局

Minutes in upright position per day

时间窗: During hospital stay, an average of one week

Sitting, standing or walking as measured by the IMU

次要结局

  • Complications within 30 days(30 days from surgery)
  • Association with type of fracture(During hospital stay, an average of one week)
  • Association with type of surgical method(During hospital stay, an average of one week)
  • Association with duration of surgery(During hospital stay, an average of one week)
  • Association with age(During hospital stay, an average of one week)
  • Association with sex(During hospital stay, an average of one week)
  • Association with comorbidities (ASA grade)(During hospital stay, an average of one week)
  • Association with frailty (CFS)(During hospital stay, an average of one week)
  • Association with presence of dementia(During hospital stay, an average of one week)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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