Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evolution of oximetry at 3 week from baseline
研究概览
简要总结
The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:
- can a significant increase in oxygen pressure be observed at 3 weeks?
- can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?
详细描述
Peripheral arterial disease (PAD) is a frequent pathology that affects more than 200 million people worldwide, more than 800,000 in France, and is mainly of atheromatous origin. The prevalence of this disease in France is estimated at 11% in people over 40 years of age, with an annual additional cost of €11,000 per patient. Supervised exercise therapy (SET) is the first-line treatment for intermittent claudication PAD for at least 3 months, although 15-20% of patients will not benefit from this therapy. Ankle-Brachial Index, the main diagnostic and monitoring tool for PAD, is not altered during SET. Transcutaneous oximetry (TcPO2) has been used for many years in the diagnosis of chronic permanent ischaemia, in the choice of amputation level and more recently in the diagnosis of proximal PAD.
No studies have investigated the evolution and predictive value of exercise TcPO2 in this context of SET. The assessment of arterial Doppler waveform using an objective classification has also never been performed in the specific context of SET. .
The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:
- can a significant increase in oxygen pressure be observed at 3 weeks?
- can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks.
The perspective is to predict the effectiveness of SET in terms of maximum walking distance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •PAD with intermittent claudication
- •SET prescribed
- •ABI < 0.9
- •Beneficiary of French health care insurance
排除标准
- •PAD with rest ischemia
- •Chronic respiratory failure
- •Acute decompensated disease
- •Lower limb prosthesis
- •Pregnant women and breastfeeding mothers
- •Place of residence more than 100 km from Caen University Hospital
结局指标
主要结局
Evolution of oximetry at 3 week from baseline
时间窗: at 3 weeks
To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)
次要结局
- Evolution of doppler waveform at 12 week from baseline(12 weeks)
- Evolution of oximetry at 6 week from baseline(at 6 weeks)
- Evolution of doppler waveform at 9 week from baseline(9 weeks)
- Evolution of doppler waveform at 3 week from baseline(at 3 weeks)
- Evolution of doppler waveform at 6 week from baseline(6 weeks)
- Evolution of oximetry at 9 week from baseline(at 9 weeks)
- Evolution of oximetry at 12 week from baseline(at 12 weeks)