Trial Outcomes & Findings for Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD) (NCT NCT01971008)
NCT ID: NCT01971008
Last Updated: 2023-03-10
Results Overview
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).
COMPLETED
PHASE2
15 participants
3 days
2023-03-10
Participant Flow
18 patients were screened for elegibility between May 2013 and January 2014 at the Department of Neurology of the Medical University of Innsbruck
15 patients were randomized to receive either the abdominal binder or the Placebo binder first; 3 patients failed to meet all inclusion criteria.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Elastic Abdominal Binder, Then Placebo Binder
n=6 Participants
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
n=9 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: 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.
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).
Outcome measures
| Measure |
Placebo Binder
n=12 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Placebo binder
|
Elastic Abdominal Binder
n=12 Participants
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Elastic abdominal binder
|
|---|---|---|
|
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 mmHg
Standard Deviation 9.6
|
7.7 mmHg
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 3 daysUsing 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.
Outcome measures
| Measure |
Placebo Binder
n=12 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Placebo binder
|
Elastic Abdominal Binder
n=12 Participants
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Elastic abdominal binder
|
|---|---|---|
|
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 mmHg
Standard Deviation 14.7
|
9.3 mmHg
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 3 daysUsing 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.
Outcome measures
| Measure |
Placebo Binder
n=12 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Placebo binder
|
Elastic Abdominal Binder
n=12 Participants
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Elastic abdominal binder
|
|---|---|---|
|
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 mmHg
Standard Deviation 8.2
|
6.9 mmHg
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 3 daysUsing 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).
Outcome measures
| Measure |
Placebo Binder
n=10 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Placebo binder
|
Elastic Abdominal Binder
n=10 Participants
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Elastic abdominal binder
|
|---|---|---|
|
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 mmHg
Standard Deviation 12.8
|
6.5 mmHg
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 3 daysUsing 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).
Outcome measures
| Measure |
Placebo Binder
n=12 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Placebo binder
|
Elastic Abdominal Binder
n=12 Participants
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Elastic abdominal binder
|
|---|---|---|
|
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 mmHg
Standard Deviation 12.8
|
2.6 mmHg
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 4 weeksUpon 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.
Outcome measures
| Measure |
Placebo Binder
n=12 Participants
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
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
Elastic abdominal binder
|
|---|---|---|
|
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 points (scale 0 to 10)
Standard Deviation 1.5
|
—
|
Adverse Events
Elastic Abdominal Binder
Placebo Binder
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elastic Abdominal Binder
n=13 participants at risk
3 days (cross-over phase) plus 4-weeks open-label extention phase
|
Placebo Binder
n=12 participants at risk
3 days (cross-over phase)
|
|---|---|---|
|
Gastrointestinal disorders
Gastro-esophageal reflux
|
7.7%
1/13 • Number of events 1 • 3 days (for the randomized, cross-over, single blinded phase) plus 4 weeks open label extension phase
|
0.00%
0/12 • 3 days (for the randomized, cross-over, single blinded phase) plus 4 weeks open label extension phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place