Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension
Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension.
Gérond'if
44 participants
Feb 14, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The prevalence of orthostatic hypotension will be characterized by the percentage of patients with a decrease of ≥ 20mmHg in systolic blood pressure or ≥ 10mmHg in diastolic blood pressure following the supine/standing postural change position.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06694688