Parkinson's Disease and ParkinsonismNCT05194748
Diaphragmatic Thickness and Pulmonary Function in Parkinson's Disease
An observational study of Parkinson's Disease and Parkinsonism, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound can give important information about the morphology of the diaphragm and the amount of contraction. Our aim, with the prediction that a restrictive pathology will occur in the pulmonary function with the addition of camptocormia in Parkinson's patients; to compare respiratory functions in Parkinson's… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2021to 15 Feb 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Individuals diagnosed with Parkinson's Disease in our clinic between June 2021 and January 2023.
Who may be able to join
- Being diagnosed with Parkinson's
- Volunteer to participate in the study
Who cannot join
- Being in contact with or suffering from COVID-19
- Having diseases that increase intra-abdominal pressure and venous insufficiency
- Having diseases that affect diaphragmatic motility
- Have had recent thoracic or abdominal surgery
- Having a parenchymal, pleural, or chest wall mass that may cause restriction on a recent chest X-ray or CT
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Faculty of Health Science
Bolu, 14100
About this study
Official title: Correlation of Diaphragmatic Thickness With Pulmonary Function in Parkinson's Disease
Ultrasound can give important information about the morphology of the diaphragm and the amount of contraction. Our aim, with the prediction that a restrictive pathology will occur in the pulmonary function with the addition of camptocormia in Parkinson's patients; to compare respiratory functions in Parkinson's patients with and without camptocormia, to investigate the correlation between ultrasonographically measured diaphragmatic thickness and pulmonary function test values.
Read the detailed description
Respiratory complications are one of the most common causes of death in Parkinson's patients. In Parkinson's disease, abnormal flexion of the thoracolumbar spine of 45° or more, which is called camptocormia, increases during walking or standing and disappears completely in the supine position. The prevalence of camptocormia among Parkinson's patients is about 7%. Camptocormia in Parkinson's disease is associated with significant disease disability, higher daily dopaminergic drug dosage, and cognitive impairment. Parkinson's patients with camptocormia often complain of shortness of breath, attributed to reduced pulmonary capacity due to limited chest expansion. Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.
Diaphragmatic thickness indicates diaphragmatic contraction and is correlated with PFT. Our aim; It is a comparison of respiratory functions in Parkinson's patients with and without camptocormia.
- Conditions
- Parkinson's Disease and Parkinsonism
- Being tested
- No intervention, observational only
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational onlyOther
No intervention, observational only
| Study group | Role | What they receive |
|---|---|---|
| camptocormia group | Diaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back Receives: Other: No intervention, observational only | |
| no camptocormia group | Diaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back Receives: Other: No intervention, observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
When the patient is in the suIt will be evaluated by conventional spirometric measurements. Pulmonary function tests will be applied to all individuals in a sitting position with the "Vmax Encore PFT system, Carefusion, CA USA" brand test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC), expire in the first second of forced expiration (FEV1), and the ratio of FEV1 to FVC (FEV1/FVC) will be recorded.pine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound
Measured: 1 hour
Ultrasonography
When the patient is in the supine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound
Measured: 1 hour
Secondary outcomes (1)
Camptocormia measurement
Postural deviations of the spine, knees and hips will be recorded through photographs taken from the side and back in the standing position. The individual's flexion of more than 45° from the thoracolumbar spine will be recorded as the presence of camptocormia. Waist, right and left knee circumference measurements also recorded
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start24 Dec 2021
- Primary completion1 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan Kurul, Ph.D, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194748
- Sponsor's protocol ID
- AIBU-FTR-ETB-002
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Diaphragmatic Thickness With Pulmonary Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05194748
- Acronym / sponsor ID
- AIBU-FTR-ETB-002
- Conditions
- Parkinson's Disease and Parkinsonism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 18 Jan 2022 (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.
Ultrasound can give important information about the morphology of the diaphragm and the amount of contraction. Our aim, with the prediction that a restrictive pathology will occur in the pulmonary function with the addition of camptocormia in Parkinson's patients; to compare respiratory functions in Parkinson's patients with and without camptocormia, to investigate the correlation between ultrasonographically measured diaphragmatic thickness and pulmonary function test values.
Detailed description
Respiratory complications are one of the most common causes of death in Parkinson's patients. In Parkinson's disease, abnormal flexion of the thoracolumbar spine of 45° or more, which is called camptocormia, increases during walking or standing and disappears completely in the supine position. The prevalence of camptocormia among Parkinson's patients is about 7%. Camptocormia in Parkinson's disease is associated with significant disease disability, higher daily dopaminergic drug dosage, and cognitive impairment. Parkinson's patients with camptocormia often complain of shortness of breath, attributed to reduced pulmonary capacity due to limited chest expansion. Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.
Diaphragmatic thickness indicates diaphragmatic contraction and is correlated with PFT. Our aim; It is a comparison of respiratory functions in Parkinson's patients with and without camptocormia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| camptocormia group | – | Other: No intervention, observational onlyDiaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back |
| no camptocormia group | – | Other: No intervention, observational onlyDiaphragmatic thickness will be measured by ultrasonography. Respiratory function will be evaluated by spirometric measurements. Postural deviations of the spine, knees, and hips will be recorded through photographs taken from the side and back |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with Parkinson's Disease in our clinic between June 2021 and January 2023.
Key inclusion criteria (2 listed)
- Being diagnosed with Parkinson's
- Volunteer to participate in the study
Key exclusion criteria (5 listed)
- Being in contact with or suffering from COVID-19
- Having diseases that increase intra-abdominal pressure and venous insufficiency
- Having diseases that affect diaphragmatic motility
- Have had recent thoracic or abdominal surgery
- Having a parenchymal, pleural, or chest wall mass that may cause restriction on a recent chest X-ray or CT
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 |
|---|---|---|
| No intervention, observational onlyNo intervention, observational only | Other | camptocormia group, no camptocormia group |
Primary outcome
Pulmonary function test
Time frame: 1 hour
When the patient is in the suIt will be evaluated by conventional spirometric measurements. Pulmonary function tests will be applied to all individuals in a sitting position with the "Vmax Encore PFT system, Carefusion, CA USA" brand test device. In each measurement, the maneuvers will be repeated at least 3 times and the best values will be recorded. Forced vital capacity (FVC), expire in the first second of forced expiration (FEV1), and the ratio of FEV1 to FVC (FEV1/FVC) will be recorded.pine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound
Ultrasonography
Time frame: 1 hour
When the patient is in the supine position, by placing a transducer on the chest wall at the level of the right 9th intercostal space, diaphragmatic movement will be monitored during inspiration, and diaphragmatic thickness will be measured at the end of expiration and inspiration. Thrombus location was evaluated proximal and/or distally by performing Doppler ultrasound
1 secondary outcome
Camptocormia measurement
Time frame: 1 hour
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 26 Apr 2024.
- 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.
Ramazan Kurul, Ph.D principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonism, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 26 Apr 2024. 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 Turkey (Türkiye). 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?
Pulmonary function test (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2024.