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