Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Broca Hospital
RECRUITING
Paris
Broca Hospital
NOT_YET_RECRUITING
Paris
Contact Information
Primary
ISABELLE DUFOUR
isabelle.dufour@gerondif.org
33 (0) 185781011
Backup
Prisca LUCAS, Ph.D & MPH
prisca.lucas@gerondif.org
33 (0) 185737323
Time Frame
Start Date: 2025-02-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 44
Treatments
Other: 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~.
Sponsors
Collaborators: Thuasne
Leads: Gérond'if

This content was sourced from clinicaltrials.gov