Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Percentage of home-based GPS recordings that are analyzable
研究概览
简要总结
The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).
详细描述
The measurement of walking capacity in PAD patients is an important step in the management of such patients. The gold standard method to assess this walking capacity is the measurement of the maximal walking distance on a treadmill. However, treadmill measurement are not readily accessible and the relationship with free-living walking capacity is, although not well known, weak. A novel approach was developed using a Global Positioning System in order to assess community-based walking capacity. This method showed interesting results, validating the technique, but was limited to one laboratory and to the place where the measurements were performed. The next step is therefore to assess the feasibility of home-based measurement of walking capacity using the GPS technique, through a multicenter study regrouping university hospitals, independent vascular specialists (angiologists) and private clinic(s).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ABI < 0.90 or patients with vascular history (surgery, endovascular treatment) and having vascular type claudication
- •Older than 18 years
- •Vascular-type claudication (defined by the Leriche classification and the Edimbourg questionnaire criterion)
- •Informed consent of the patient
- •Non-Inclusion Criteria:
- •No informed consent of the patient
- •Exercise (walking) limitation other than vascular explained limitation
- •Critical limb ischemia (Leriche stage 3 or 4)
- •Major cardiovascular events in the last 3 months
- •Pregnant woman
- •Patient unable to understand the protocol of the study
排除标准
- •Withdrawal of the informed consent of the patient following the inclusion period
- •Emergence of a non-inclusion criteria during the inclusion period
- •Patient with a GPS maximal walking distance > 2000 meters following the first evaluation (can not be considered as having a major walking limitation)
结局指标
主要结局
Percentage of home-based GPS recordings that are analyzable
时间窗: December 2011
次要结局
- "Technical quality" of recorded GPS signals(December 2011)
- Easiness of the interpretation of the GPS measurements(December 2011)
- Adherence of the patients to the protocol(December 2011)
- Compare GPS results to the results obtained with different questionnaires (external validity)(December 2011)
- Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)(December 2011)