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临床试验/NCT02387034
NCT02387034Unknown不适用

The Effect on Swedish Physical Activity on Prescription (PAP) in Patients in Primary Care With Osteoarthritis in Knee or Hip - a RCT-study.

Uppsala University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
1
主要终点
Physical activity level

研究概览

简要总结

The purpose of this study is to determine whether an intervention with Physical activity on prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life.

The hypothesis is that patients with osteoarthritis in hip or knee will increase their level of physical activity significantly more with a PAP intervention compared to patients who only get general advice about physical activity.

详细描述

According to guidelines the recommended first-line management for people with osteoarthritis consist of exercise, information about osteoarthritis and if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in these patients. Therefore, it is important to have methods to increase physical activity levels in these patients. It is not explored whether an intervention with PAP may lead to increased physical activity in patients with knee or hip osteoarthritis. The study will be a prospective, randomized, single-blind intervention study including 140 patients (70 patients/group). Patients will in a parallel design be randomized to intervention or control group. Both groups receive oral and written information about osteoarthritis and if necessary, advice on weight loss. The intervention group receives Swedish Physical activity on prescription. It is a patient-centered counselling about physical activity related to the disease. The counselling results in an individualized written prescription on physical activity including specific modes on physical activity. After three weeks, three months and six months they are offered a follow up which could be by telephone or personal meeting. During the follow up they discuss who the physical activity works out and plan new goals. The control group will receive an intervention with general advice about being active three times a week and do strength training functional during the day. Patients in the control group see the physiotherapist once.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with clinically verified osteoarthritis in knee or hip
  • •Sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes

排除标准

  • •Severe pain in hip or knee when walking
  • •Other serious disorders causing problems when walking
  • •Back injury causing pain in the leg
  • •Cruciate ligament injury in the knee which causes severe dysfunction
  • •Severe menisci injury
  • •Total joint replacement in hip or knee
  • •Unable to understand Swedish and follow verbal visual instructions
  • •Study population: Patients who contact primary care center because of their hip or knee osteoarthritis and which is referred to the physical therapist. Seven health centers in Gävle include patients.

研究组 & 干预措施

Physical activity on prescription (PAP)

Experimental

Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months.

干预措施: Physical activity on prescription (Behavioral)

General advice

Other

Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about being active with cardiovascular exercise such as walking, cycling or otherwise in 30 minutes three times a week and do strength training functional during the day such as walk in stairs and getting up from a chair without hand support.

干预措施: General advice (Other)

结局指标

主要结局

Physical activity level

时间窗: Change from baseline to 6, 12, 24 months

Physical activity will be measured with an activity monitor (accelerometer).

次要结局

  • Body composition(Change from baseline to 6,12, 24 months)
  • Health related quality of Life , general(Change from baseline to 6,12,24 months)
  • Physical activity level(Change from baseline to 6,12,24 months)
  • Health related quality of Life, disease specific(Change from baseline to 6,12,24 months)
  • Walking distance(Change from baseline to 6,12,24 months)
  • Leg muscle strength and function(Change from baseline to 6,12,24 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margareta Emtner

Assoiciate Professor

Uppsala University

研究点 (1)

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