Phase 2
N=15
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Parkinson's Disease · Neurogenic Orthostatic Hypotension in Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01971008 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: 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 — -2.3; 7.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elastic abdominal binder (Device); Placebo binder (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Medical University Innsbruck
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-2.3; 7.7 | — |
| SECONDARY 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 |
-6.2; 9.3 | — |
| SECONDARY 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 |
-0.3; 6.9 | — |
| SECONDARY 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 |
-6.4; 6.5 | — |
| SECONDARY 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 |
-2.2; 2.6 | — |
| SECONDARY 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 |
-2.5 | — |
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
Eligibility Criteria
Inclusion Criteria
- Idiopathic PD
- Hoehn & Yahr stadium or = C2, "varicose veins")
- Known or suspected pregnancy
- Breast feeding
Data sourced from ClinicalTrials.gov (NCT01971008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.