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

June 30, 2023 updated by: Andrea Maier, RWTH Aachen University

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

Study on orthostatic Hypotension in Parkinson's disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • University Hospital, RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Short_Physiotherapy
one period of physiotherapy (8 weeks)
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.
Other: Long_Physiotherapy
two periods of physiotherapy (à 8 weeks)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure in mmHg
Time Frame: 10months
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
Time Frame: 10months
Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy
10months
Orthostatic symptoms (Winkler Scale)
Time Frame: 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
10months
daytime sleepiness
Time Frame: 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
10months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Andrea Maier, Dr. med., Universitiy hospital RWTH Aachen, Department of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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