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临床试验/ACTRN12618001097235
ACTRN12618001097235终止未知

WALK - A pilot randomised controlled trial evaluating the feasibility of community walking for knee osteoarthritis

Menzies Institute for Medical Research, University of Tasmania0 个研究点目标入组 40 人开始时间: 2018年7月2日最近更新:
适应症

试验速览

阶段
未知
状态
终止
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment

入排标准

年龄范围
45 Years 至 o limit(—)
性别
All

入选标准

  • 1)Males and females aged 45 or over;
  • 2)Have clinically diagnosed knee OA (according to the American College of Rheumatology criteria);
  • 3)Have had symptomatic knee OA for at least 6 months with a pain visual analogue scale (VAS) score of at least 40mm/100mm over the last 7 days;
  • 4)Have a bone marrow lesion (BML) present on MRI (prevalence 88% at screening in our recent clinical trial).
  • 5)Have no difficulty in walking a city block (75-100 metres).
  • 6)Be willing to participate in a walking program for 6 months, and can attend on days/times of the week that scheduled walking classes are running.

排除标准

  • 1)Severe knee pain (on standing greater than 80mm/100mm on VAS);
  • 2)Participation in any form of exercise at a moderate/vigorous level for >150 min/week or walking >10,000 steps/day – will be assessed for 7 consecutive days during screening using Actigraph accelerometers (meta-analysis data demonstrates that few knee OA sufferers meet these levels of activity (13% and 19% respectively));
  • 3)Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance; see below for the procedure for this);
  • 4)Other forms of arthritis in which disease is active and concomitant medication is used (e.g., rheumatoid arthritis);
  • 5)Participants who have undergone significant trauma to the ‘study’ knee in the previous 12 months (injury, arthroscopy or open surgery);
  • 6)Receiving intra-articular therapy (e.g. corticosteroids, hyaluronic acid) in the study knee in the last 6 months;
  • 7)Anticipated need for knee or hip surgery within the next 6 months;
  • 8)Contra-indication to MRI (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for scanner);
  • 9)Plan to commence exercise or another new treatment for knee OA in the next 6 months.
  • 10)Use of a gait aid.
  • 11)Inability to give informed consent.

研究者

发起方
Menzies Institute for Medical Research, University of Tasmania

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