Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression.
研究概览
简要总结
Orthostatic hypotension (OH) is associated with an increased risk of myocardial infarction, stroke, heart failure and neurocognitive disorders. In the elderly, OH is an independent predictor of falls and mortality. Non-drug treatments are used as the first-line treatments. Among non-drug treatments, compression of the lower limbs and abdominal compression have been shown to help reduce OH and associated symptoms. As these studies were solely based on ankle-to-thigh bandages, the effectiveness of other medical devices developed, such as compression socks and tights, needs to be evaluated. In addition, data comparing the efficacy and tolerability of several approaches, single or combined, of several levels of compression, provided by socks, tights and an abdominal belt are scarce. The HYPOFLEX study aims to provide new data to enable better management of OH.
详细描述
Patients will be recruited from a single center, over a 12-month inclusion period. The clinical investigation will focus on CE-marked Class I medical devices, used for their intended purpose, as part of a post-market clinical follow-up with additional non-invasive, non-invasive procedures. Randomization will be carried out to determine the order of the 5 conditions studied:
- No compression,
- Class 2 compression socks,
- Class 3 compression socks,
- Class 2 compression tights,
- Dynabelt abdominal belt + Class 2 compression socks. Conditions will be tested over half a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 60 or over,
- •Patients hospitalized at Broca Hospital with orthostatic hypotension,
- •Patient able to stand,
- •Patient who has been medically stable for at least 48 hours,
- •Patient whose measurements are compatible with Thuasne compression device sizes,
- •Patient having been informed, having received answers to his questions and having signed the informed consent form prior to his participation in the study,
- •Patient affiliated or entitled to a social security number.
排除标准
- •Patients presenting, according to the investigator, a contraindication to lower limb and/or abdominal compression,
- •Patients presenting any contraindication mentioned in the instructions for use of the medical devices under investigation.
- •Patient presenting, according to the investigator, a major cognitive impairment incompatible with participation in a clinical trial,
- •Patient taking part in another clinical investigation conducted to establish the conformity of a medical device having an impact on the outcomes,
- •Vulnerable patient according to article L1121-6 of the Public Health Code, subject to a judicial protection measure or incapable of consenting to a clinical trial or incapable of giving informed consent.
研究组 & 干预措施
a single group of patients
Subject will undergo the following 5 conditions in the cross-over scheme as determined by the randomization:
No compression, Class 2 compression socks, Class 3 compression socks, Class 2 compression tights and Dynabelt abdominal belt + Class 2 compression socks
.
干预措施: the supine/standing postural change test (Diagnostic Test)
结局指标
主要结局
Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression.
时间窗: 12 months
Decrease in systolic BP when moving from the supine to the standing position, using a semi-automatic blood pressure monitor (Dynamap type): * supine BP: average of 3 measurements taken after a rest of at least 5 minutes * BP in upright position: lowest value of measurements obtained every minute for 5 minutes after rising, Without compression and with class 2 compression of the lower limbs.
次要结局
- Decrease in systolic blood pressure when moving from the supine to the upright position(12 months)
- Characterize orthostatic hypotension(12 months)
- Evaluate patient satisfaction and tolerance(12 months)
- Severity of orthostatic hypotension(12 months)