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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01971008
First Posted: October 28, 2013
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klaus Seppi, Medical University Innsbruck
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 Klaus Seppi, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Effects of an abdominal binder on orthostatic symptoms in daily living during 4-weeks open label trial [ Time Frame: 4 weeks ]
  • 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 ]

Estimated Enrollment: 14
Study Start Date: May 2013
Study Completion Date: May 2014
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

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971008


Locations
Austria
Department of Neurology - Medical University Innsbruck
Innsbruck, Tirol, Austria, 6020
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
First Submitted: October 17, 2013
First Posted: October 28, 2013
Last Update Posted: August 13, 2014
Last Verified: August 2014

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