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

RWTH Aachen University30 enrolled

Overview

Study on orthostatic Hypotension in Parkinson's disease

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Hypotension, Orthostatic Parkinson Disease Autonomic Failure Cognitive Impairment

Interventions

PhysiotherapyOTHER

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Blood Pressure in mmHg

Systolic postural blood pressure drop in the interventional Group (Long\_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short\_Physiotherapy

Time frame: 10months

Secondary Outcomes

Attention in TAP

Attention Tasks (TAP) ≥ 20% Change in Long\_Physiotherapy

Time frame: 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

Time frame: 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

Time frame: 10months

Data from ClinicalTrials.gov

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