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

NCT03900000 | Completed

• 1 other identifier: 13-131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Study on orthostatic Hypotension in Parkinson's disease

Conditions

Hypotension, Orthostatic; Parkinson Disease; Autonomic Failure; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Blood Pressure in mmHg

  Systolic postural blood pressure drop in the interventional Group (Long\_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short\_Physiotherapy

  10months

Secondary Outcomes (3)

• Attention in TAP

  10months

• Orthostatic symptoms (Winkler Scale)

  10months

• daytime sleepiness

  10months

Study Arms (2)

Short_Physiotherapy

OTHER

one period of physiotherapy (8 weeks)

Other: Physiotherapy

Long_Physiotherapy

OTHER

two periods of physiotherapy (à 8 weeks)

Other: Physiotherapy

Interventions

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.

Long_Physiotherapy; Short_Physiotherapy

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's patients
• Diagnostis of OH
• able to perform an ambulatory physiotherapy at Aachen University Hospital.

You may not qualify if:

• deep brain stimulation or Pacemaker
• severe psychiatric disease
• severe heart disease
• severe vascular encephalopathy
• dementia
• pregnant or lactating women
• extreme pain or immobility

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 35705801 RESULT

Related Links

• Results of the study

MeSH Terms

Conditions

Hypotension, Orthostatic; Parkinson Disease; Pure Autonomic Failure; Cognitive Dysfunction

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Andrea Maier, Dr. med.

  Universitiy hospital RWTH Aachen, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician and investigator

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: April 2, 2019
• Study Start: May 1, 2014
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)