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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Klaus Seppi, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01971008
First received: October 17, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Neurogenic Orthostatic Hypotension in Parkinson's Disease
Device: Elastic abdominal binder
Device: Placebo binder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Abdominal Binders for the Treatment of Orthostatic Hypotension in Parkinson's Disease: an Investigator-initiated Randomized, Placebo-controlled, Cross-over Study

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Effect of an elastic abdominal binder versus a placebo binder on mean blood pressure (mmHg) after 3 minutes of orthostatic challenge (on passive tilting) with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of an elastic abdominal binder versus a placebo binder on systolic blood pressure (mmHg) after 3 minutes of orthostatic challenge with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Effect of an elastic abdominal binder versus a placebo binder on diastolic blood pressure (mmHg) after 3 minutes of orthostatic challenge with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Effect of an elastic abdominal binder with respect to a placebo binder on orthostatic symptoms after 3 minutes of orthostatic challenge in Parkinson's disease patients suffering from neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Effect of an elastic abdominal binder with respect to a placebo binder on mean supine blood pressure (mmHg) in Parkinson's disease patients suffering from neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Effects of an abdominal binder on orthostatic symptoms in daily living during 4-weeks open label trial [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Effect of an elastic abdominal binder versus a placebo binder on mean blood pressure (mmHg) after 3 minutes of orthostatic challenge (on active standing) with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: May 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo binder
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Device: Placebo binder
Other Name: "Clima Care" Body warmer, Bort Medical
Active Comparator: Elastic abdominal binder
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Device: Elastic abdominal binder
Other Name: "Abdosyncro" Abdominalbandage, Syncro Med GmbH

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971008

Contacts
Contact: Klaus Seppi, Univ. Prof. Dr. +4351250481498 klaus.seppi@uki.at

Locations
Austria
Department of Neurology - Medical University Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Klaus Seppi, Univ. Prof. Dr.    +4351250481498    klaus.seppi@uki.at   
Sub-Investigator: Gregor Karl Wenning, Univ. Prof. DDr.         
Sub-Investigator: Werner Poewe, Univ. Prof.         
Sub-Investigator: Alessandra Fanciulli, Dr.         
Sub-Investigator: Fabienne Sprenger, Dr.         
Sub-Investigator: Bernard Metzler, Univ. Prof. Dr.         
Sub-Investigator: Georg Goebel, Univ. Prof.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Klaus Seppi, Univ. Prof. Dr. Department of Neurology - Medical University Innsbruck
  More Information

Additional Information:
Publications:
Responsible Party: Klaus Seppi, Univ. Prof. Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01971008     History of Changes
Other Study ID Numbers: ABOHP
Study First Received: October 17, 2013
Last Updated: March 19, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hypotension, Orthostatic
Hypotension
Parkinson Disease
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 24, 2014