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

NCT ID: NCT03900000

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-10-31

Brief Summary

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Study on orthostatic Hypotension in Parkinson's disease

Detailed Description

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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.

Conditions

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Hypotension, Orthostatic Parkinson Disease Autonomic Failure Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Short_Physiotherapy

one period of physiotherapy (8 weeks)

Group Type OTHER

Physiotherapy

Intervention Type 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.

Long_Physiotherapy

two periods of physiotherapy (à 8 weeks)

Group Type OTHER

Physiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Andrea Maier

attending physician and investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Maier, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitiy hospital RWTH Aachen, Department of Neurology

Locations

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University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 35705801 (View on PubMed)

Related Links

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Other Identifiers

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13-131

Identifier Type: -

Identifier Source: org_study_id

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