Clinical trial NCT01971008: Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Official title: Abdominal Binders for the Treatment of Orthostatic Hypotension in Parkinson's Disease: an Investigator-initiated Randomized, Placebo-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Neurogenic Orthostatic Hypotension in Parkinson's Disease
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline, When Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 3 days
Secondary outcomes:
measure: Change in Systolic Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline When Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 3 days
measure: Change in Diastolic Blood Pressure (mmHg) After 3 Minutes of Passive Orthostatic Challenge From Baseline if Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 3 days
measure: Change in Mean Blood Pressure (mmHg) After 3 Minutes of Active Orthostatic Challenge From Baseline When Wearing an Elastic Abdominal Binder Versus a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 3 days
measure: Change in Supine Mean Blood Pressure (mmHg) if Wearing an Elastic Abdominal Binder vs a Placebo Binder for 2 Hours Each in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 3 days
measure: Change in Orthostatic Hypotension Questionnaire Total Score After 4-weeks Open Label Trial With an Elastic Abdominal Binder With Respect to Baseline in People With Parkinson's Disease and Neurogenic Orthostatic Hypotension
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Neurology - Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Department of Neurology - Medical University Innsbruck
name: Klaus Seppi, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3(0 3):S42-80. doi: 10.1002/mds.23884.
citation: Ferreira JJ, Katzenschlager R, Bloem BR, Bonuccelli U, Burn D, Deuschl G, Dietrichs E, Fabbrini G, Friedman A, Kanovsky P, Kostic V, Nieuwboer A, Odin P, Poewe W, Rascol O, Sampaio C, Schupbach M, Tolosa E, Trenkwalder C, Schapira A, Berardelli A, Oertel WH. Summary of the recommendations of the EFNS/MDS-ES review on therapeutic management of Parkinson's disease. Eur J Neurol. 2013 Jan;20(1):5-15. doi: 10.1111/j.1468-1331.2012.03866.x.
citation: Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice Parameter: treatment of nonmotor symptoms of Parkinson disease [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. doi: 10.1212/WNL.0b013e3181d55f24.