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

Parkinson Disease Clinical Trial

— PaKogOH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900000
• Other study ID #: 13-131
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2023
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study on orthostatic Hypotension in Parkinson's disease

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Failure
• Cognitive Impairment
• Hypotension
• Hypotension, Orthostatic
• Parkinson Disease
• Pure Autonomic Failure

Intervention

Other:
• Physiotherapy
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.

Locations

Country	Name	City	State
Germany	University Hospital, RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Husch S, Schauermann J, Fimm B, Haubrich C, Reetz K, Schulz JB, Maier A. Effect of strength training on orthostatic hypotension in Parkinson's disease-a pilot study. Clin Auton Res. 2022 Jun;32(3):213-217. doi: 10.1007/s10286-022-00870-5. Epub 2022 Jun 15 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Attention in TAP	Attention Tasks (TAP) = 20% Change in Long_Physiotherapy	10months
Secondary	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
Secondary	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

External Links

•   Results of the study