Autonomic Failure, Cognitive Impairment, Hypotension, Orthostatic, Parkinson Disease
Conditions
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.
Interventions
OTHERPhysiotherapy
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.
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure in mmHg | 10months | Systolic postural blood pressure drop in the interventional Group (Long\_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short\_Physiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attention in TAP | 10months | Attention Tasks (TAP) ≥ 20% Change in Long\_Physiotherapy |
| Orthostatic symptoms (Winkler Scale) | 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 |
| daytime sleepiness | 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 |
Countries
Germany
Outcome results
None listed