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

Phase 2

Completed

Conditions: Parkinson's Disease
Neurogenic Orthostatic Hypotension in Parkinson's Disease

Interventions: Device: Placebo binder
Device: Elastic abdominal binder

Registration Number: NCT01971008

Lead Sponsor: Medical University Innsbruck

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo binder, then elastic abdominal binder	Placebo binder	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
Elastic abdominal binder, then placebo binder	Elastic abdominal binder	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

Primary Outcome Measures

Name	Time	Method
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	3 days	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

Name	Time	Method
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	3 days	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 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	3 days	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	3 days	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	3 days	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	4 weeks	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.