Abdominal Compression in Orthostatic Hypotension

Not Applicable

Completed

• Conditions: Orthostatic Hypotension; Autonomic Failure
• Interventions: Other: Abdominal binder; Other: No abdominal binder

• Registration Number: NCT01223391
• Lead Sponsor: Mayo Clinic

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 Description

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.

Study Timeline

• Study First Submitted: 2010-09-28
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Abdominal binder	Abdominal binder	Standing with abdominal compression using elastic vs. non-elastic abdominal binders.
No abdominal binder	No abdominal binder	Standing without abdominal compression

Primary Outcome Measures

Name	Time	Method
Difference between averaged standing blood pressure with and without binders	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.

Secondary Outcome Measures

Name	Time	Method
Difference in orthostatic symptom score with and without binders	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States