Abdominal Compression in Orthostatic Hypotension

NCT ID: NCT01223391

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-08-31

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.

Conditions

Autonomic Failure; Orthostatic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdominal binder

Standing with abdominal compression using elastic vs. non-elastic abdominal binders.

Group Type: EXPERIMENTAL

Abdominal binder

Intervention Type: OTHER

External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.

No abdominal binder

Standing without abdominal compression

Group Type: PLACEBO_COMPARATOR

No abdominal binder

Intervention Type: OTHER

Standing without abdominal binder for 3 minutes

Interventions

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.

Intervention Type: OTHER

No abdominal binder

Standing without abdominal binder for 3 minutes

Intervention Type: OTHER

Other Intervention Names

Elastic abdominal binder; Non-elastic abdominal binder

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Jeffrey Basford, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

10-005203

Identifier Type: -

Identifier Source: org_study_id