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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic abdominal binder, then placebo binder | Experimental | 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 |
|
| Placebo binder, then elastic abdominal binder | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic abdominal binder | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Seppi, Univ. Prof. Dr. | Department of Neurology - Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology - Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22021174 | Background | 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. | |
| 23279439 |
| Label | URL |
|---|---|
| Coordination center for clinical studies of the Medical University Innsbruck | View source |
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15 patients were randomized to receive either the abdominal binder or the Placebo binder first; 3 patients failed to meet all inclusion criteria.
18 patients were screened for elegibility between May 2013 and January 2014 at the Department of Neurology of the Medical University of Innsbruck
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| ID | Title | Description |
|---|---|---|
| FG000 | Elastic Abdominal Binder, Then Placebo 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. |
| FG001 | Placebo Binder, Then Elastic Abdominal 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elastic Abdominal Binder, Then Placebo 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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). | Fifteen patients were randomized. Three patients dropped-out during the cross-over phase (1 from the placebo-abdominal binder group and 2 from the abdominal binder-placebo group) and data from 12 patients were available for the primary outcome analysis. | Posted | Mean | Standard Deviation | mmHg | 3 days |
3 days (for the randomized, cross-over, single blinded phase) plus 4 weeks open label extension phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elastic Abdominal Binder | 3 days (cross-over phase) plus 4-weeks open-label extention phase |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastro-esophageal reflux | Gastrointestinal disorders | Systematic Assessment | One patient reported exacerbation of gastroesophageal reflux during the 4-weeks open-label follow-up: this might have been related to regular use of the abdominal binder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Klaus Seppi | Innsbruck Medical University | 004351250481498 | klaus.seppi@tirol-kliniken.at |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)
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| Placebo binder | Device |
|
|
| 3 days |
| 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. | 3 days |
| 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). | 3 days |
| 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). | 3 days |
| 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. | 4 weeks |
| 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. |
| 20231670 | Background | 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 [RETIRED]: 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. |
| Placebo Binder, Then Elastic Abdominal 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mmHg | 3 days |
|
|
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| 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 | 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. | Posted | Mean | Standard Deviation | mmHg | 3 days |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | mmHg | 3 days |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | mmHg | 3 days |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | points (scale 0 to 10) | 4 weeks |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Placebo Binder | 3 days (cross-over phase) | 0 | 12 | 0 | 12 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |