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临床试验/NCT00279994
NCT00279994Unknown不适用

Exercise Therapy in Patients With Peripheral Arterial Disease: the Costs and Effectiveness of Physiotherapeutic Supervision With or Without Therapy Feedback Versus a "go Home and Walk" Advice

Atrium Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
maximal walking distance

研究概览

简要总结

The purpose of this study is to determine if supervised exercise therapy in a physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than exercise therapy based on a 'go home and walk' advice without supervision, for patients with PAD stage II (Fontaine).

详细描述

Exercise therapy (ET) is considered to be the main conservative treatment for patients with intermittent claudication (IC) and is documented to be effective, especially when supervised. However, wide scale introduction of supervised ET in the Netherlands would lead to a substantial increase of health care costs compared to current practice, while the cost-effectiveness of supervised ET is uncertain. ET follows a pattern of short walking periods that induce discomfort of moderate intensity and short rest periods. The psychological, metabolic, and mechanical alterations that occur during exercise stimulate an adaptive response that ultimately reduces the symptoms. The optimal therapy regimen depends to a large extent on home-based exercises, which require discipline from the patient. Currently, the main prescription for ET for patients with IC in the Netherlands is a single 'go home and walk' advice, without supervision or follow-up. There is no evidence to support the effectiveness of this advice and compliance is low. In studies comparing the 'go home and walk' advice to supervised ET, a large advantage for supervised ET was present. The inadequate use of the main conservative treatment for peripheral arterial disease (PAD) contributes to a gradual progression of this condition, a decrease in quality of life, and an increasing number of vascular interventions. Furthermore, with adequate ET, hypertension, hypercholesterolemia, overweight, and diabetes, if present, is better regulated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •PAD stage II
  • •Ankle-brachial index below 0.9
  • •Maximal walking distance of 500 meters or less

排除标准

  • •previous peripheral vascular interventions
  • •no insurance for physiotherapy
  • •insufficient command of the Dutch language
  • •serious cardiopulmonary limitations (NYHA-3-4)
  • •previous amputation
  • •psychiatric instability
  • •other serious co-morbidity prohibiting physical training

结局指标

主要结局

maximal walking distance

次要结局

  • pain-free walking distance
  • blood pressure
  • fasting glucose
  • fasting cholesterol
  • lipids profile
  • body weight
  • co-morbidity
  • vascular interventions
  • mortality
  • medical and non-medical costs
  • compliance
  • quality of life
  • impairment
  • complaints

研究者

申办方类型
Other

研究点 (1)

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