The purpose of the present clinical trial is to determine whether the use of an elastic abdominal binder is effective in the non-pharmacological management of symptomatic, neurogenic orthostatic hypotension (OH) in individuals suffering from Parkinson's disease (PD) or Parkinson variant multiple system atrophy (MSA-P).
This is a monocentric, randomized, placebo-controlled, double-blind, crossover phase II clinical trial with an open-label treatment extension phase. The investigators plan to recruit n = 30 individuals with MSA-P or PD with known or suspected OH. At the Screening Visit, after patient information and written informed consent, the participants will first undergo a comprehensive neurological and cardiological evaluation, as well cardiovascular autonomic function testing to confirm the diagnosis of symptomatic, neurogenic OH. Afterwards, the participants will be asked to wear physical activity monitoring (PAM) sensors for five consecutive days and to measure the blood pressure (BP) regularly following a home BP diary (i.e. Home Phase I). On treatment day-1 (i.e. Visit 1), the participants will undergo an instrumented in-lab gait analysis, followed by a head-up tilt and active standing test. Afterwards, they will wear the first type of binder for two hours (either the investigational elastic abdominal binder or the placebo-comparator binder, depending on the randomization assignment). At the end of the two hours, the participants will repeat the in-lab gait analysis and the head-up tilt-/active standing test. After one-day wash-out, the same procedure of treatment day-1 (i.e. Visit 1) will be repeated with the outstanding type of binder (i.e. treatment day-2, Visit 2). At the end of this, all participants will be invited to wear the investigational elastic abdominal binder and the PAM sensors for five more days and to repeat the home BP measurements (i.e. Home Phase II). A final follow-up visit is scheduled to return the PAM sensors, the BP monitor and to detect eventual adverse and serious adverse events occurred during Home Phase II.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH).
"Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer.
Medical University Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGEffect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
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Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of head-up tilt test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 \[Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")\]
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 10th minute of head-up tilt test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 \[Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")\]
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of active standing test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 \[Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")\]
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean gait velocity with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean stride length with respect to baseline.
Time frame: 3 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test in the early morning.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test 60 minutes after lunch.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on highest supine systolic BP values (mmHg) at 5th minute before home active standing test in the evening.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on OH symptom severity.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" \[Range: 0 (minimum, i.e. "no symptoms") to 100 (maximum, i.e. "worst possible symptoms")\], including subcales "Orthostatic Hypotension Symptom Assessment" \[Range: 0 (minimum, i.e. "no symptoms") to 60 (maximum, i.e. "worst possible symptoms")\] and "Orthostatic Hypotension Daily Activitiy Scale" \[Range: 0 (minimum, i.e. "no interference") to 40 (maximum, i.e. "total interference")\], as well as single-item scores \[Range: 0 (minimum, i.e. "no symptoms/interference") to 10 (maximum, i.e. "worst possible symptoms/total interference")\]
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on overall mobility.
Overall mobility measured by the International Physical Activity Questionnaire (IPAQ), indicated in total physical activity metabolic equivalent minutes per week (i.e. total MET-minutes/week) \[Range: 0 (minimum, i.e. "no physical activity"), no maximum (i.e. the higher the better the overall mobility)\]
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived number of walking bouts.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived duration of walking bouts.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean gait velocity.
Time frame: 10 days
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean stride length.
Time frame: 10 days
Number of participants with treatment-related adverse events.
Adverse event rates will be coded by body system and MedDRA classification terms. Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, the severity and relationship to the investigational medical device.
Time frame: 8 days