Hypotension, OrthostaticPaKogOHNCT03900000
Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease
A study testing Physiotherapy in people with Hypotension, Orthostatic and Parkinson Disease, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Study on orthostatic Hypotension in Parkinson's disease Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Hypotension, Orthostatic, Parkinson Disease, Autonomic Failure
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's patients
- Diagnostis of OH
- able to perform an ambulatory physiotherapy at Aachen University Hospital.
Who cannot join
- deep brain stimulation or Pacemaker
- severe psychiatric disease
- severe heart disease
- severe vascular encephalopathy
- dementia
- pregnant or lactating women
- extreme pain or immobility
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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
Study on orthostatic Hypotension in Parkinson's disease
Read the 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.
- Being tested
- Physiotherapy
- Medical subject headings
- Hypotension, Orthostatic, Parkinson Disease, Pure Autonomic Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Short_Physiotherapy | Other | one period of physiotherapy (8 weeks) Receives: Other: Physiotherapy |
| Long_Physiotherapy | Other | two periods of physiotherapy (à 8 weeks) Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure in mmHg
Systolic postural blood pressure drop in the interventional Group (Long_Physiotherapy) less than 10mmHg (5-15mmHg) compared to Short_Physiotherapy
Measured: 10months
Secondary outcomes (3)
Attention in TAP
Attention Tasks (TAP) ≥ 20% Change in Long_Physiotherapy
Measured: 10months
Orthostatic symptoms (Winkler Scale)
≥ 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
Measured: 10months
daytime sleepiness
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
Measured: 10months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study startMay 2014
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension, OrthostaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Maier, RWTH Aachen University
- Investigators
- Andrea Maier, Dr. med., Principal investigator, Universitiy hospital RWTH Aachen, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900000
- Sponsor's protocol ID
- 13-131
- Acronym
- PaKogOH
- Status last verified
- Jun 2023
- First submitted
- 28 Dec 2018
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35705801
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03900000
- Acronym / sponsor ID
- PaKogOH / 13-131
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short_Physiotherapy | Other | Other: Physiotherapyone period of physiotherapy (8 weeks) |
| Long_Physiotherapy | Other | Other: Physiotherapytwo periods of physiotherapy (à 8 weeks) |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's patients
- Diagnostis of OH
- able to perform an ambulatory physiotherapy at Aachen University Hospital.
Key exclusion criteria (7 listed)
- deep brain stimulation or Pacemaker
- severe psychiatric disease
- severe heart disease
- severe vascular encephalopathy
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAmbulatory 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. | Other | Long_Physiotherapy, Short_Physiotherapy |
Primary outcome
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
3 secondary outcomes
Attention in TAP
Time frame: 10months
Orthostatic symptoms (Winkler Scale)
Time frame: 10months
daytime sleepiness
Time frame: 10months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Results publication: PubMed 35705801Husch 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.
- Results of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Maier, Dr. med. principal investigator
Universitiy hospital RWTH Aachen, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Hypotension, Orthostatic and Parkinson Disease, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure in mmHg (time frame: 10months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.