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临床试验/NCT01622465
NCT01622465已完成2 期

Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty: Randomized Controlled Trial

University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Change from baseline in hip function at three months

研究概览

简要总结

The aim of this study is to evaluate the effects of an exercise program with a cycle ergometer in functional outcome and related-health quality of life (RHQL) in elderly patients with total hip arthroplasty.

详细描述

Behavioral: Ergometer Cycling Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed two times a week for a time period of at least eith weeks.

Behavioral: No ergometer cycling Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery, only conventional exercises.

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
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Aged patients (60 years or more) of both sexes
  • Being submitted to the total hip arthroplasty, primary and unilateral, for hip osteoarthritis or hip osteonecrosis
  • no history of physical therapy two months before surgery

排除标准

  • arthroplasty of hip fracture or other condition;
  • neurological disease that compromises motor function;
  • postoperative complications (dislocation, infection, cardiovascular events);
  • revision of the prosthesis;
  • patients who are unable to attend the sessions of physical therapy or refused to participate in the study

结局指标

主要结局

Change from baseline in hip function at three months

时间窗: Baseline and three months

Harris Hip Score (HHS) will be used to collect the data at baseline and at three months

次要结局

  • Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire(Baseline and three months)
  • Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire(Baseline and three months)
  • Change from baseline in physical performance of lower limbs at three months.(Baseline and three months)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Katia Rampazo

Principal Investigator

University of Campinas, Brazil

研究点 (2)

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