Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD) (ABOHP)

Medical University Innsbruck

Status and phase: Completed; Phase 2

Conditions: Neurogenic Orthostatic Hypotension in Parkinson's Disease; Parkinson's Disease

Treatments: Device: Elastic abdominal binder; Device: Placebo binder

Study type: Interventional

Funder types: Other

Identifiers

NCT01971008

ABOHP

Details and patient eligibility

About

The purpose of the present study is to determine whether the use of an abdominal binder is effective in the non-pharmacological management of orthostatic hypotension in patients suffering from Parkinson's disease

Full description

In the present single blinded cross-over trial we investigated the effects of an elastic abdominal binder on blood pressure changes (systolic, diastolic and mean blood pressure) after 3 minutes of head-up tilt test in patients with Parkinson's disease and orthostatic hypotension.

Secondarily, we investigated the effects of an elastic abdominal binder on symptoms of orthostatic hypotension in daily living in a 4-weeks open-label follow-up.

Enrollment: 15 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic PD
• Hoehn & Yahr stadium < or = 4
• Age: 40-90
• Laboratory confirmed neurogenic orthostatic hypotension (NOH)
• Stable pharmacological therapy in the last 6 weeks
• Full legal competence

Exclusion criteria

• Other major neurologic or psychiatric diseases
• Untreated diabetes mellitus with clinical features of peripheral neuropathy
• Major cardiac diseases (ischemic, structural, arrhythmias)
• Evidence of varices (venous insufficiency stage > or = C2, "varicose veins")
• Known or suspected pregnancy
• Breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Elastic abdominal binder, then placebo binder

Experimental group

Description:

Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 1 and a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 3, after wash-out on day 2

Treatment:

Device: Elastic abdominal binder

Placebo binder, then elastic abdominal binder

Experimental group

Description:

Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 1 and an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 3, after wash-out on day 2

Treatment:

Device: Placebo binder