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临床试验/NCT01245842
NCT01245842已完成不适用

Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial

Diakonhjemmet Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2011年1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
130
试验地点
2
主要终点
Patient specific function scale (PSFS)

研究概览

简要总结

The purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis .

详细描述

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population. The disease may have large influences on an individual's function, health related quality of life and participation in the society. In recently published clinical guidelines for management, non-pharmacological approaches are considered as core treatments.

Several studies have demonstrated that exercise may reduce pain and improve function in persons with knee OA, and a similar effect is suggested for hip OA. Regarding effect of exercises in hand OA, available research results are limited, and randomised controlled trials (RCT) of good quality are needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis
  • FIHOA ≥ 5 at pre-baseline
  • The persons must have a telephone

排除标准

  • Persons with cognitive dysfunction
  • Persons who do not understand Norwegian language
  • Persons with inflammatory rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis) or cancer
  • Persons that have recently experienced severe trauma
  • Persons that have recently gone through OA surgery or other major surgery

结局指标

主要结局

Patient specific function scale (PSFS)

时间窗: 6 months

The functional index for hand osteoarthritis (FIHOA)

时间窗: 6 months

次要结局

  • Self-reported health care utilisation(6 months)
  • Grip strength (JAMAR)(6 months)
  • Hand functioning (The Moberg Pick Up Test)(6 months)
  • Global assessment of change of hand problem(6 months)
  • Fatigue (numeric rating scale, 0-10)(6 months)
  • Health related quality of life (15D)(6 months)
  • Self-reported work ability and sick leave(6 months)
  • Hand joint pain (Numeric rating scale, 0-10)(6 months)
  • Hand joint stiffness (Numeric rating scale, 0-10)(6 months)
  • Patient global assessment of disease activity (Numeric rating scale, 0-10)(6 months)
  • Exercise self-efficacy(6 months)
  • Grip size(6 months)

研究者

发起方
Diakonhjemmet Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Osteras

Principal Investigator

Diakonhjemmet Hospital

研究点 (2)

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The Hand Osteoarthritis Exercise Trial | 临床试验