search
Back to results

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

Primary Purpose

Hypotension, Orthostatic, Parkinson Disease, Autonomic Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypotension, Orthostatic

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Short_Physiotherapy

Long_Physiotherapy

Arm Description

one period of physiotherapy (8 weeks)

two periods of physiotherapy (à 8 weeks)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Attention in TAP
Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy
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
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

Full Information

First Posted
December 28, 2018
Last Updated
June 30, 2023
Sponsor
RWTH Aachen University
search

1. Study Identification

Unique Protocol Identification Number
NCT03900000
Brief Title
Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Orthostatic, Parkinson Disease, Autonomic Failure, Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short_Physiotherapy
Arm Type
Other
Arm Description
one period of physiotherapy (8 weeks)
Arm Title
Long_Physiotherapy
Arm Type
Other
Arm Description
two periods of physiotherapy (à 8 weeks)
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure in mmHg
Description
Systolic postural blood pressure drop in the interventional Group (Long_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short_Physiotherapy
Time Frame
10months
Secondary Outcome Measure Information:
Title
Attention in TAP
Description
Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy
Time Frame
10months
Title
Orthostatic symptoms (Winkler Scale)
Description
≥ 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
Title
daytime sleepiness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Maier, Dr. med.
Organizational Affiliation
Universitiy hospital RWTH Aachen, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35705801
Citation
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. No abstract available.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35705801/
Description
Results of the study

Learn more about this trial

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

We'll reach out to this number within 24 hrs