G20.2 G23.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be included if they meet the following inclusion criteria: 1. Diagnosis of PD according to the UK Brain Bank Criteria or MSA, Parkinson type, 2. symptomatic OH (OHQ symptom assessment item 1 = 1), and 3. moderate OH (systolic/diastolic blood pressure drop of at least 20/10 mmHg within 3 min of standing or head-up tilt to at least 60° on a tilt table) or severe OH (BP drop = 30/15 mmHg).
Exclusion criteria
Exclusion criteria: Exclusion criteria comprise end stage PD (H & Y stage = 5), OH due to medication side effects (diuretics, alpha adrenergics for bladder disorder, sympatholytics, vasadilatators, antidepressants, antihypertensives), pharmacological treatment of OH (fludrocortisone, midodrine, droxidopa), other severe neurological, psychiatric or cardiac diseases, severe diabetes mellitus, severe peripheral neuropathy, pregnancy/breast feeding, and changes of the medical therapy in the 4 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of compression stockings versus abdominal binder therapy on physical activity, i.e. number of sit to stand movements per week as a surrogate marker for physical activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise the effects on the following domains: quality of life (PDQ-39), blood pressure drop as measured by tilting table, orthostatic symptoms (orthostatic hypotension questionnaire), activities/instrumental activities of daily living (ADL/iADL), PD symptoms (Movement Disorder Society unified Parkinson’s disease rating scale, MDS-UPDRS, parts I-IV), non-motor Parkinson’s disease symptoms (NMSS), autonomic symptoms (Scopa-AUT), clinician/patient global impression (CGI-S, PGI-S), and number of syncopes/severe dizziness/falls (patient diary). | — |
Countries
Germany
Contacts
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie