Abdominal Compression in Orthostatic Hypotension

The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension

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.

Study Overview

• Status: Completed
• Conditions: Orthostatic Hypotension; Autonomic Failure
• Intervention / Treatment: Other: Abdominal binder; Other: No abdominal binder

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
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between averaged standing blood pressure with and without binders	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.	3-7 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in orthostatic symptom score with and without binders	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.	3-7 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jeffrey Basford, MD, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: orthostatic; abdominal compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic; Pure Autonomic Failure
• Other Study ID Numbers: 10-005203