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Completed

NCT Number: NCT03900000

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

Study on orthostatic Hypotension in Parkinson's disease

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Key information

Conditions

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

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study 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

Acronym: PaKogOH

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2019
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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