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临床试验/NCT01387867
NCT01387867已完成不适用

Effects of Strength Training and Nordic Walking in Patients With Osteoarthritis of the Hip

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
2
主要终点
Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months

研究概览

简要总结

According to Danish and international guidelines the recommended first-line of management for people with osteoarthritis consist of exercise, education, analgesic medication, and, if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in patients with knee OA, but the effect of exercise on hip OA is sparsely investigated.

Aim of the study: To investigate the effects of 1) strength training, and 2) Nordic Walking, and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical activity, and health related quality of life in patients with osteoarthritis of the hip.

The effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e., disease activity, inflammation, and cartilage degradation, are investigated in a subgroup (n=45) of the participants.

Study hypotheses: Strength training will have a greater effect on physical function and muscle strength than Nordic Walking and home based exercise; 2) Nordic Walking will have a greater effect on endurance than strength training and unsupervised home based exercise; 3) Strength training and Nordic Walking will have a greater effect on pain level and health related quality of life than unsupervised home based exercise.

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 (Investigator)

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

  • Home-dwelling 60+ year old persons with primary, symptomatic hip OA who meet the clinical criteria of hip OA according to American College of Rheumatology (ACR), and who are not on a waiting list for hip joint replacement.

排除标准

  • symptomatic OA in the knee or the big toe,
  • joint replacement of the knee or the hip,
  • other types of arthritis, e.g., rheumatoid arthritis,
  • previous hip fracture,
  • limitation in physical function to the extent that using public transportation is impossible,
  • co-morbidity that prevents exercising,
  • physiotherapy related to hip problems within the last 3 months,
  • steroid injections in the hip joint within the last 3 months,
  • performing exercise/sports 2+ times weekly, and
  • inability to cooperate.

结局指标

主要结局

Change from Baseline to 2, 4 and 12 months in number of chair stands in 30 sec at 2, 4 and 12 months

时间窗: Baseline, 2, 4 and 12 months

次要结局

  • Change from Baseline to 2, 4 and 12 months in isometric muscle strength (N) of the thigh and hip muscles at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline to 2, 4 and 12 months in lower limb extensor muscle power (Watt/kg BW) at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline to 2, 4 and 12 months in 6 minute walking distance (m), stair climbing time (s), 15 s marching on the spot (number of knee lifts), Timed-Up-and-Go (s) at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline in self-reported pain level at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline in self-reported physical activity at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline in health related quality of life at 2, 4 and 12 months(Baseline, 2, 4, and 12 months)
  • Change from Baseline to 4 months in the anatomical cross sectional area (cm2) of the quadriceps femoris muscle measured with MRI. The measurements are performed in a subgroup (15 participants from each group)(Baseline and 4 months)
  • Change from Baseline to 4 months in biomarkers of disease activity, inflammation, and cartilage degradation, in a subgroup (15 participants from each group)(Baseline and 4 months)
  • Change in task specific self-efficacy from baseline to 2, 4 and 12 months(Baseline, 2, 4 and 12 months)
  • Change in patient global assessment from baseline to 2, 4 and 12 months.(Baseline to 2, 4 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. Nina Beyer

Assoc. Prof.

Bispebjerg Hospital

研究点 (2)

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