Clinical Trial: Abdominal Compression in Orthostatic Hypotension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension

Brief Summary: The purpose of this study is to assess if abdominal binders that use pull strings to adjust compression (non-elastic) are more effective than standard elastic abdominal binders in attenuating neurogenic orthostatic hypotension.

Detailed Summary: In 3 protocols, patients will undergo standing maneuvers, measured abdominal compressions, continuous BP monitoring and symptoms, ease-of-use and compliance scoring. In protocol 1, patients will exert abdominal compression to maximal tolerable and comfortable levels and values will be recorded. In protocol 2, patients will perform 3 standing maneuvers following a preceding rest period with and without abdominal compression at 20 mmHg (binders used in random order). In protocol 3, the standing maneuvers will be extended and the investigator will adjust binders to levels of abdominal compression corresponding to what patient gauged as maximal tolerable and comfortable levels. Comparison of outcome measures will establish which binder achieves higher abdominal compression, is easier to adjust, likely will be used in the future, if elastic and adjustable binders are equally effective in attenuating Orthostatic Hypotension and its associated symptoms at comparable pressures and which binder is more effective in recovering standing BP and improving orthostatic symptoms.
Sponsor: Mayo Clinic

Current Primary Outcome: Difference between averaged standing blood pressure with and without binders [ Time Frame: 3-7 minutes ]

A 1-minute averaged blood pressure is measured at 3 minutes of standing without abdominal binder and at 3, 4.5 and 6.5 minutes of standing with abdominal binders. All measurements are obtained during a single session.


Original Primary Outcome: Same as current

Current Secondary Outcome: Difference in orthostatic symptom score with and without binders [ Time Frame: 3-7 minutes ]

Orthostatic symptoms are measured at 3 minutes of standing without abdominal binder, and at 3, 4.5 and 6.5 minutes of standing with abdominal binders. All measurements are obtained during a single session.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: September 28, 2010
Date Started: October 2010
Date Completion:
Last Updated: May 9, 2014
Last Verified: May 2014