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

Not Applicable

Completed

• Conditions: Hypotension, Orthostatic; Parkinson Disease; Cognitive Impairment; Autonomic Failure
• Interventions: Other: Physiotherapy

• Registration Number: NCT03900000
• Lead Sponsor: RWTH Aachen University

Brief Summary

Study on orthostatic Hypotension in Parkinson's disease

Detailed Description

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 Timeline

• Study Start: 2014-05
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Short_Physiotherapy	Physiotherapy	one period of physiotherapy (8 weeks)
Long_Physiotherapy	Physiotherapy	two periods of physiotherapy (à 8 weeks)

Primary Outcome Measures

Name	Time	Method
Blood Pressure in mmHg	10months	Systolic postural blood pressure drop in the interventional Group (Long_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short_Physiotherapy

Secondary Outcome Measures

Name	Time	Method
daytime sleepiness	10months	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
Orthostatic symptoms (Winkler Scale)	10months	≥ 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
Attention in TAP	10months	Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy

Trial Locations

Locations (1)

University Hospital, RWTH Aachen; 🇩🇪 Aachen, NRW, Germany