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

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ClinicalTrials.gov Identifier: NCT03900000
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
Study on orthostatic Hypotension in Parkinson's disease

Condition or disease Intervention/treatment Phase
Hypotension, Orthostatic Parkinson Disease Autonomic Failure Cognitive Impairment Other: Physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Attention in TAP [ Time Frame: 10months ]
    Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy

  2. 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

  3. 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



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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900000


Locations
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Germany
University Hospital, RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Andrea Maier, Dr. med. Universitiy hospital RWTH Aachen, Department of Neurology

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03900000     History of Changes
Other Study ID Numbers: 13-131
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Hypotension
Pure Autonomic Failure
Hypotension, Orthostatic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Orthostatic Intolerance