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临床试验/NCT01553305
NCT01553305已完成不适用

The Effect of 6-weeks Supervised Exercise Programme Followed by 6-weeks Unsupervised Exercise Programme Versus 12 Weeks Unsupervised Exercise Programme in Patients With Rheumatoid Arthritis.

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Change in muscle strength (kg)

研究概览

简要总结

The purpose of this study is to compare the effectiveness of a supervised high-intensity exercise programme followed by an unsupervised exercise programme to an unsupervised exercise programme in patients with Rheumatoid Arthritis.

详细描述

Patients with Rheumatoid Arthritis are in general less fit and more at risk of comorbidities such as cardiovascular events compared with healthy age-matched controls. Studies indicates that patients with Rheumatoid Arthritis have a lower level of physical activity than the general population and a low proportion of patients with Rheumatoid Arthritis exercises. Regular exercise with moderate to high intensity level of intensity has proven to be effective in reducing the cardiovascular risk by improving cardiovascular fitness and to increase muscle strength. Therefore, it is of interest to investigate if supervised exercise programme makes a difference making patients with Rheumatoid Arthritis participate in exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with Rheumatoid Arthritis within the last three years at Aarhus University Hospital according to the 1987 revised ACR criteria or the 2009 ACR/EULAR criteria
  • •must be able to sit on an exercise bike
  • •must be able to participate in 6-weeks exercise programme with training sessions twice a week at Aarhus University Hospital
  • •must be able to speak and understand danish

排除标准

  • •high disease activity assessed by DAS28-CRP
  • •Myocardial Infarction within the last six months
  • •Angina Pectoris
  • •treated with beta-blocker
  • •severe high blood pressure
  • •severe lung disease

研究组 & 干预措施

Supervised exercise programme

Experimental

Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.

干预措施: Supervised high-intensity exercise programme (Other)

Supervised exercise programme

Experimental

Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.

干预措施: Exercise programme (Other)

Unsupervised exercise programme

No Intervention

结局指标

主要结局

Change in muscle strength (kg)

时间窗: Muscle strength is measured at baseline and follow-up. The outcome is change in muscle strength in 12 weeks from baseline to follow-up.

次要结局

  • Change in cardiovascular fitness(Cardiovascular fitness is measured at baseline and follow-up. The outcome is change in cardiovascular fitness in 12 weeks from baseline to follow-up.)

研究者

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

Trine Seneca

Physiotherapist

Aarhus University Hospital

研究点 (1)

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