Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease

Study Overview
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Brief Summary
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Study on orthostatic Hypotension in Parkinson's disease

Detailed Description
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Orthostatic hypotension (OH) in Parkinson's disease (PD) may not only be related to dizziness or light headedness but to deficits in attention, visual, and verbal memory. Would a successful treatment of OH which includes physiotherapy significantly improve OH and these cognitive deficits? By means of a randomized cross-over trial, we want to measure and compare the effects of OH therapy on orthostatic tolerance, as well as on attention, visuo-spatial working memory, and verbal memory in patients with PD. If confirmed, therapy of orthostatic hypotension would provide a sound and simple approach to improve those cognitive deficits originating from orthostatic hypotension.

Official Title
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Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease: Does a Successful Treatment of Orthostatic Hypotension Measurably Enhance Attention and Memory Functions in Parkinson's Disease

Conditions
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Hypotension, Orthostatic, Parkinson Disease, Autonomic Failure, Cognitive Impairment

Intervention / Treatment
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* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's patients Diagnostis of OH able to perform an ambulatory physiotherapy at Aachen University Hospital. Exclusion Criteria: deep brain stimulation or Pacemaker severe psychiatric disease severe heart disease severe vascular encephalopathy dementia pregnant or lactating women extreme pain or immobility

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Short_Physiotherapy<br>one period of physiotherapy (8 weeks) | Other: Physiotherapy<br>* Ambulatory leg-muscle oriented physiotherapy (2 x 45 minutes per week for at least 8 weeks) at Aachen University Hospital. Daily protocol of leg muscle training, exercises, sufficient fluid intake of 2liter/day, pressure stockings.<br>|
| Other: Long_Physiotherapy<br>two periods of physiotherapy (à 8 weeks) | Other: Physiotherapy<br>* Ambulatory leg-muscle oriented physiotherapy (2 x 45 minutes per week for at least 8 weeks) at Aachen University Hospital. Daily protocol of leg muscle training, exercises, sufficient fluid intake of 2liter/day, pressure stockings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure in mmHg | Systolic postural blood pressure drop in the interventional Group (Long_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short_Physiotherapy | 10months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention in TAP | Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy | 10months | 
| Orthostatic symptoms (Winkler Scale) | ≥ 2 points change in Winkler Scale (Sum Score) in Long_Physiotherapy; 10 symptoms must be rated concerning their frequency from 0= never to 4= more than once a day. Sum score from minimum 0 points (no symptoms) to maximum 40 points (all symptoms more than once daily) is interpreted | 10months | 
| daytime sleepiness | Epworth Sleepiness Scale ≥ 20% Change of Sum Score in Long_Physiotherapy. Sum Score can range from minimum = 0 Points to Maximum = 24points. More points indicate more symptoms. Cut off for daytime sleepiness are10 points | 10months |