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临床试验/NCT03156075
NCT03156075已完成不适用

Sponsor Investigator, Assistant Professor at Public Health and Community Medicine Department, Faculty of Medicine, Assiut University

Dalia Mahran0 个研究点目标入组 124 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
主要终点
Mortality

研究概览

简要总结

The aim of the study is to investigate whether a simple intervention improves the physical functioning and reduce mortality after surgery for elderly hip fracture patients in a period of one year follow up. We hypothesized that the postoperative intervention program decreases the mortality in one year and improves mobility.

This study is a randomized controlled trial designed as a prospective intervention and a historical control group from the previous three months admitted operated hip fracture patients from another study and with bone mineral density and measurement of weight and height done. The study will include patients of both sexes, 50 years and older, after their approval to participate and applying exclusion criteria. A baseline assessment will be done for the included hip fracture patients, who will be admitted to Trauma Unit of Assiut University Hospitals and will be surgically treated for a period of 1 year. The exclusion criteria include patients with major accidents, polytrauma, pathological fractures and bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac diseases, long term immobilization, liver diseases and musculoskeletal disorders. Two well-trained nurses will carry out the personal interviews in the Trauma Unit ward with each patient and/or patients 'relatives using a structured questionnaire. Data collection will be done after providing informed consent.

Bone mineral density, weight and height for every patient will be done. The follow up phone calls will be done for every patient at 3 months, 6 months and one year postoperative.

Intervention group:

Patients in the intervention Group will be provided with postoperative health education intervention program, which includes nutrition education for improving general and bone health and physical exercise training for the patient and his relative before discharge.

This group will receive the usual care prior to the start of intervention and participating in the study.

The phone calls will include questions about: if the patient is alive or not. If not, subsequent detailed questions about causes and timing of death will be filled in.

If the patient is alive, subsequent questions about nutrition, commodities and physical activity will be filled in. Assessment of physical activity will be done by the Western Ontario And McMaster Universities Osteoarthritis Index (WOMAC).

详细描述

The aim of the study is to investigate whether a simple intervention improves the physical functioning and reduce mortality after surgery for elderly hip fracture patients in a period of one year follow up. We hypothesized that the postoperative intervention program decreases the mortality in one year and improves mobility.

This study is a randomized controlled trial designed as a prospective intervention and a historical control group from the previous three months admitted operated hip fracture patients from another study and with bone mineral density and measurement of weight and height done.

The study will include patients of both sexes, 50 years and older, after their approval to participate and applying exclusion criteria. A baseline assessment will be done for the included hip fracture patients, who will be admitted to Trauma Unit of Assiut University Hospitals and will be surgically treated for a period of 1 year. We aim to minimize other factors that affect the intervention program compliance and could increase the mortality. The exclusion criteria include patients with major accidents, polytrauma, pathological fractures and bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac diseases, long term immobilization, liver diseases and musculoskeletal disorders.

Two well-trained nurses will carry out the personal interviews in the Trauma Unit ward with each patient and/or patients 'relatives using a structured questionnaire. Data collection will be done after providing informed consent. The questionnaire for baseline data includes sociodemographic characteristics such as name, sex, and age, associated comorbidities and some nutrition habits. The nutrition habits in pre and post intervention will be evaluated by the dietary history qualitative subjective method using closed ended questions [1].

Bone mineral density (BMD) evaluation and anthropometric measurements:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • All patients postoperative hip fracture from 50 years and above from both sexes and admitted to Trauma Unit at Assiut University Hospitals

排除标准

  • patients with major accidents, polytrauma, pathological fractures and bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac diseases, long term immobilization, liver diseases and musculoskeletal disorders.

结局指标

主要结局

Mortality

时间窗: immediately postoperative to one year after operation

Postoperative hip fracture mortality of the patients

次要结局

  • Mobility(from three months to one year postoperative)

研究者

发起方
Dalia Mahran
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dalia Mahran

Assistant professor

Assiut University

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