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临床试验/NCT02141126
NCT02141126已完成不适用

Can Lower Limb Resistance Training Improve Strength, Muscle Mass and Functional Outcomes in Older Inpatients in a Post-acute Rehabilitation Unit? A Randomised Controlled Feasibility Study

Royal College of Surgeons, Ireland2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年7月1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
60
试验地点
2
主要终点
Lower limb dynamometry

研究概览

简要总结

The primary aim of this feasibility study is to evaluate the feasibility of delivering a PRT programme in an inpatient older person rehabilitation setting and to describe changes in lower limb strength and physical function following six weeks of resistance training and routine physiotherapy versus a control group of routine physiotherapy only in an older inpatient population.

详细描述

This is a prospective, single blinded, randomised controlled feasibility study recruiting consecutive appropriate patients in this post-acute rehabilitation unit.

Feasibility outcomes including safety, recruitment, measurements, adherence, retention and satisfaction will be evaluated. There are two groups (i) exercise intervention and (ii) control. It will not be possible to blind the treating physiotherapist or the patient to the exercise intervention; hence the single (assessor) blinded design.

The study will be based in St James's Hospital, Dublin. Assessments and the delivery of the exercise intervention will be conducted in the Physiotherapy department.

Patients will be recruited in the inpatient setting. Appropriate patients will be approached, and the intervention explained to them. The patient will be given an information leaflet and 24-hours to consider involvement in the study

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
Single (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

  • Patients, male and female elderly inpatients 65 years.
  • Patients must be medically stable.
  • Patients who are able to follow one-stage commands.
  • Patients must be able to give informed consent.

排除标准

  • Unstable medical condition.
  • Patients who are unable to follow one-stage commands.
  • Acute pain or fracture
  • Patients who are unable to stand or require more than assistance of two staff to mobilise/transfer.
  • Patients who have been admitted with a recent diagnosis of stroke, due to their varying patterns of recovery.

结局指标

主要结局

Lower limb dynamometry

时间窗: Baseline, Week 6

Lower limb dynamometry will be measured using the Power Track II Commander by J-Tech Medical. A previous study in this rehabilitation unit has determined that this is a reliable measure of lower limb strength in this population. The primary outcome measurement will be quadriceps muscle strength.

次要结局

  • Functional mobility using the Timed Up and Go (TUG)(Baseline, Week 6)
  • EuroQol-5D (EQ-5D)(Baseline, Week 6)
  • Canadian Study of Health and Ageing Clinical Frailty Scale (CFS)(Baseline, Week 6)
  • Six Minute Walk Test (6MWT)(Baseline, Week 6)

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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