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临床试验/NCT03247205
NCT03247205撤回不适用

Feasibility of Extended Post-Acute Intervention for Hip Fracture Patients With Cognitive Limitations: Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study (HipERS)

University of Maryland, Baltimore2 个研究点 分布在 1 个国家开始时间: 2018年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Feasibility of the Intervention (time)

研究概览

简要总结

This pilot study will look at whether it is possible to give better physical therapy to people with cognitive limitations who have had a hip fracture.

详细描述

Although a small number of interventions have been found to be effective in improving mobility and functional recovery after a hip fracture, these studies have routinely excluded patients with cognitive limitations, a group with poor outcomes after hip fracture. It is estimated that 15-20% of all hip fracture patients experience cognitive limitation following surgery from previously undetected cognitive impairment, delirium, and other post-operative complications that persist following hospital discharge and those with cognitive limitations are slow to recover. Despite potential for a full recovery, many hip fracture patients with cognitive limitation may be discharged early from rehabilitation settings due to misperceptions about rehabilitation potential, or other psychological issues that limit their participation.

The innovation of this study is that it focuses on a critically vulnerable and costly group of patients (hip fracture patients with cognitive limitations) with an extended intervention that is tailored to the patient's needs and cognitive abilities. The post-rehabilitation period after hip fracture has been largely ignored and little is known about the effective strategies to help transition and maintain hip fracture patients (especially those with cognitive limitations) in the home setting. HipERS utilizes an effective approach to address for functional gains, but where limited attention has been given. It focuses on motivational and behavioral challenges in patients with cognitive limitations and their caregivers, which has been largely ignored in the hip fracture research

This study will gather information from 5 people with cognitive limitations who fractured a hip. Caregivers (family relative or non-relative, unpaid or paid, formal or informal) will also be invited to participate. Hip fracture participants will receive a home-based exercise intervention that will start after their "normal" rehabilitation is done. The function-based exercise intervention will be provided by physical therapists 2-3 times a week for 6 weeks. Additionally, the physical therapist will encourage the caregiver to motivate and actively engage the hip fracture participant in the therapist-prescribed home exercise program so that this can be maintained at the end of the 6-week intervention. The feasibility of the intervention will be based on the percentage of sessions participants complete. The information we get from this feasibility study will be used to plan a larger study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of the Intervention (time)

时间窗: 6 weeks

Data regarding feasibility will include total time to implement the intervention.

Treatment Fidelity

时间窗: 6 weeks

Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.

Feasibility of the Intervention

时间窗: 6 weeks

Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.

次要结局

  • Barthel Index for Activities of Daily Living(6 weeks)
  • Lower Extremity Gain Scale (LEGS)(6 weeks)
  • Neuropsychiatric Inventory (NPI)(6 weeks)
  • Zarit Burden Interview(6 weeks)
  • Short Physical Performance Battery (SPPB)(6 weeks)
  • Instrumental Activities of Daily Living (IADLs)(6 weeks)
  • Adverse Events(6 weeks)

研究者

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

Ann Gruber-Baldini

Professor

University of Maryland, Baltimore

研究点 (2)

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