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临床试验/NCT04207788
NCT04207788已完成不适用

HIp Fracture REhabilitation Programme for Elderly With Hip Fracture

Carsten Bogh Juhl2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Assessment of Motor and Process Skills

研究概览

简要总结

Objectives: To evaluate the effect of a HIP-REP on the quality and independence in ADL ability (performance), measured with the Assessment of Motor and Process Skills (AMPS) and health-related Quality of Life (QoL).

Hypothesis: The HIP-REP will increase the quality and independence in ADL performance, measured with AMPS and health-related QoL measure.

详细描述

Little is known about the effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and ADL ability. After hip fracture, the loss of independence, and further decrease in ADL ability often persists beyond three months after surgery. This increases the risk of social isolation, depression and thus a decrease in QoL. Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is effective and influences this fragile group of patients. The investigators hope to increase the ability to safely and independently perform ADL in elderly with hip fractures, and thereby enhance their health-related QoL.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • Aged 65 years or older
  • Recent proximal hip fracture (S 72.0 medial femur fracture, S 72.1, pertrochanteric femur fracture, S 72.2 subtrochanteric femur fracture)
  • Living at home prior to hip fracture in Herlev, Gentofte, Furesoe, Rudersdal or Lyngby-Taarbæk municipalities
  • Ability to give informed consent

排除标准

  • Not expected to be discharged to home or rehabilitation centers in the municipality
  • Not able to speak and/or understand Danish
  • Have prior severe physical and /or mental disabilities

结局指标

主要结局

Assessment of Motor and Process Skills

时间窗: Change frombaseline at motor and process skills 3 and 6 months after baseline testing

The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale. The rating scale is based on the following criteria (Quality of performance); 4 = Competent, 3 = Questionable, 2 = Ineffective or 1 = Severely deficient. In all, 36 discrete ratings of motor and process skills are made during observation.

次要结局

  • Verbal Rating Scale(At baseline and 3 and 6 months after baseline testing)
  • Functional Recovery Score(at baseline and 3 and 6 months after baseline testing)
  • European Quality of Life Questionnaire(At baseline and 3 and 6 months after baseline testing)

研究者

发起方
Carsten Bogh Juhl
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carsten Bogh Juhl

Principal investigator

Herlev and Gentofte Hospital

研究点 (2)

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