Abdominal Compression in Orthostatic Hypotension
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|ClinicalTrials.gov Identifier: NCT01223391|
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Autonomic Failure Orthostatic Hypotension||Other: Abdominal binder Other: No abdominal binder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Abdominal binder
Standing with abdominal compression using elastic vs. non-elastic abdominal binders.
Other: Abdominal binder
External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.
Placebo Comparator: No abdominal binder
Standing without abdominal compression
Other: No abdominal binder
Standing without abdominal binder for 3 minutes
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223391
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jeffrey Basford, MD, PhD||Mayo Clinic|