- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05194748
Diaphragmatic Thickness and Pulmonary Function in Parkinson's Disease
Correlation of Diaphragmatic Thickness With Pulmonary Function in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey, 14100
- Abant Izzet Baysal University Faculty of Health Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being diagnosed with Parkinson's
- Volunteer to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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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
|
No intervention, observational only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 hour
|
|
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
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Camptocormia measurement
Time Frame: 1 hour
|
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
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramazan Kurul, Ph.D, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-ETB-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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