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

Primary Purpose

Parkinson's Disease, Neurogenic Orthostatic Hypotension in Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Elastic abdominal binder
Placebo binder
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurology - Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Elastic abdominal binder, then placebo binder

Placebo binder, then elastic abdominal binder

Arm 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

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

Outcomes

Primary Outcome Measures

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
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).

Secondary Outcome Measures

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
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1.
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
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1.
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
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).
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
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).
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
Upon completion of the single-blinded cross-over phase, patients were invited to wear the elastic abdominal binder on daily basis for 4 weeks. We evaluated the changes in the total score of the Orthostatic Hypotension Questionnaire (OHQ, which quantifies the impact of orthostatic symptoms in daily life) after these 4 weeks with respect to baseline. The OHQ is a 10-items scale. For each item the minimum score is 0 (no symptoms) and the max score is 10 (worst symptoms severity). The OHQ total score is calculated as follows: sum of the scores in each item/10 (total score range: 0-10). Higher values indicate worse outcomes.

Full Information

First Posted
October 17, 2013
Last Updated
June 2, 2022
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT01971008
Brief Title
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Acronym
ABOHP
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Neurogenic Orthostatic Hypotension in Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elastic abdominal binder, then placebo binder
Arm Type
Experimental
Arm 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
Arm Title
Placebo binder, then elastic abdominal binder
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Elastic abdominal binder
Other Intervention Name(s)
"Abdosyncro" Abdominalbandage, Syncro Med GmbH
Intervention Type
Device
Intervention Name(s)
Placebo binder
Other Intervention Name(s)
"Clima Care" Body warmer, Bort Medical
Primary Outcome Measure Information:
Title
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
Description
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).
Time Frame
3 days
Secondary Outcome Measure Information:
Title
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
Description
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1.
Time Frame
3 days
Title
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
Description
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1.
Time Frame
3 days
Title
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
Description
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).
Time Frame
3 days
Title
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
Description
Using a single-blinded placebo-controlled cross-over design, 15 consecutive patients with PD and symptomatic OH were randomly assigned to first receive either an elastic abdominal binder (20±2mmHg pressure on the abdominal wall, Abdo-Syncro 3-stripes abdominal binder, Syncro Med GmbH) or a placebo binder (3±2mmHg pressure on the abdominal wall, Clima Care body warmer, Bort Medical GmbH) on two different days, separated by an interval of one day, to compare their efficacy on tilt-test examinations. On study day-1, all patients underwent a 1st baseline tilt-test examination. Afterwards they were asked to wear the assigned binder. Two hours later, the 1st study tilt-test was performed. The binder was subsequently taken off. Following interval on day-2, on study day-3 patients were crossed over to the other type of binder and underwent the same protocol as on day-1. Mean blood pressure was calculated as: (diastolic blood pressure +1/3(systolic blood pressure - diastolic blood pressure).
Time Frame
3 days
Title
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
Description
Upon completion of the single-blinded cross-over phase, patients were invited to wear the elastic abdominal binder on daily basis for 4 weeks. We evaluated the changes in the total score of the Orthostatic Hypotension Questionnaire (OHQ, which quantifies the impact of orthostatic symptoms in daily life) after these 4 weeks with respect to baseline. The OHQ is a 10-items scale. For each item the minimum score is 0 (no symptoms) and the max score is 10 (worst symptoms severity). The OHQ total score is calculated as follows: sum of the scores in each item/10 (total score range: 0-10). Higher values indicate worse outcomes.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Seppi, Univ. Prof. Dr.
Organizational Affiliation
Department of Neurology - Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology - Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
22021174
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.
Results Reference
background
PubMed Identifier
23279439
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.
Results Reference
background
PubMed Identifier
20231670
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: 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.
Results Reference
background
Links:
URL
https://www.i-med.ac.at/kks/
Description
Coordination center for clinical studies of the Medical University Innsbruck

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

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