Abdominal Compression in Orthostatic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01223391
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : May 12, 2014
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autonomic Failure Orthostatic Hypotension Other: Abdominal binder Other: No abdominal binder Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Other Names:
  • Elastic abdominal binder
  • Non-elastic abdominal binder

Placebo Comparator: No abdominal binder
Standing without abdominal compression
Other: No abdominal binder
Standing without abdominal binder for 3 minutes

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

SUBJECTS We will study 15 patients of both genders with neurogenic orthostatic hypotension (OH). Subjects will be recruited from the existing list of patients available in the database of the Autonomic Disorders Center.

Inclusion Criteria

  1. Men and nonpregnant women aged 18-80 years.
  2. Chronic neurologic conditions known to cause OH: multiple system atrophy (MSA), Parkinson's disease, autoimmune autonomic ganglionopathy or progressive autonomic neuropathy (e.g., diabetic, amyloid).
  3. Orthostatic hypotension defined as a drop of systolic BP>30 mmHg or diastolic BP>15 mmHg.
  4. Adrenergic failure of at least moderate severity defined as CASS-adrenergic ≥3.
  5. Ambulatory and able to stand more than 3 minutes without pre-syncope.
  6. BMI <29.
  7. Ability to comply with study procedures and appointments.
  8. Normal cognition (able to understand the study, learn the maneuvers, and follow complex commands).
  9. Concomitant therapy with anticholinergic, alpha and beta agonists will be withdrawn 48 hours prior to autonomic evaluations. Midodrine will be withdrawn the night before evaluation. Fludrocortisone doses up to 0.2 mg per day will be permitted.

The diagnosis of probable MSA requires 1) the presence of orthostatic hypotension or urinary incontinence, and 2) poorly levodopa responsive parkinsonism or cerebellar ataxia.

The diagnosis of clinically definite Parkinson's disease requires 1) the presence of resting tremor, bradykinesia and rigidity, 2) clinical asymmetry, and 3) response to levodopa.

The diagnosis of autoimmune autonomic ganglionopathy requires 1) a sub-cute onset, 2) the presence of generalized and severe autonomic failure (CASS>6), 3) selective involvement of autonomic nerve fibers and 4) positive alpha-3 nicotinic acetylcholine receptor auto-antibodies.

Exclusion Criteria

  1. Pregnant or lactating females.
  2. Non-neurogenic OH, such as that due to medication or hypovolemia.
  3. Chronic illnesses or other central nervous system conditions that affect autonomic function.
  4. Established dementia.
  5. Debilitating ataxia.
  6. Moderate to severe lower extremity weakness.
  7. Severe systemic illness, such as end-stage pulmonary, cardiac or renal disease.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01223391

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Jeffrey Basford, MD, PhD Mayo Clinic

Responsible Party: Jeffrey Basford, MD, PhD, Mayo Clinic Identifier: NCT01223391     History of Changes
Other Study ID Numbers: 10-005203
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by Mayo Clinic:
abdominal compression

Additional relevant MeSH terms:
Hypotension, Orthostatic
Pure Autonomic Failure
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases