Abdominal Compression in Orthostatic Hypotension
|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.
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|