Parkinson Disease (PD)NCT07308795
The Ultrasonographic Evaluation of Abdominal Accessory Respiratory Muscle Thickness in Patients With Parkinson's Disease: Correlation With Disease Severity and Expiratory Respiratory Muscle Strength
An observational study of Parkinson Disease (PD) and Maximum Inspiratory Pressure, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD), Maximum Inspiratory Pressure, Maximum Expiratory Pressure
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 20 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: THE GROUP WITH PARKINSON'S DIAGNOSIS AND HOEHN YAHR STAGE 1-2-3
Who may be able to join
- Age > 18 years
- Parkinson's disease diagnosis with Modified Hoehn and Yahr stages 1-2-3
- Mini-Mental State Examination (MMSE) score > 23
- Body Mass Index (BMI) < 30
Who cannot join
- Active smokers
- Individuals with a diagnosis of active chest disease
- Those with hemodynamic instability
- Individuals with unstable vital signs
- Parkinson's patients who cannot be controlled with medical treatment
- Parkinson Plus syndromes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi
Istanbul, BAHÇELİEVLER, 34180
İSTANBUL FİZİK TEDAVİ VE REHABİLİTASYON EAH İSTANBUL FİZİK TEDAVİ VE REHABİLİTASYON EAH, 0(212) 496 50 00, istanbulfth2@saglik.gov.tr
About this study
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients. In this study is to evaluate the thickness of abdominal accessory respiratory muscles using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined.
The study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength.
Read the detailed description
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients.
This observational, cross sectional study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength. In this study is to evaluate the thickness of abdominal accessory respiratory muscles (rectus abdominis, transversus abdominis, and oblique muscles) using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined. Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements. Disease severity will be evaluated using standardized clinical scales.
These findings will underscore the importance of evaluating respiratory muscles in Parkinson's disease and may contribute to the development of rehabilitation programs targeting respiratory muscles in the later stages of the disease.
- Conditions
- Parkinson Disease (PD), Maximum Inspiratory Pressure, Maximum Expiratory Pressure, Abdominal Accessory Respiratory Muscle Thickness
- Keywords
- abdominal muscles ultrasonography, parkinson disease, respiratory, MIP, abdominal muscles, respiratory muscles, expiratory muscle strenght, ultrasound, maximum expiratory pressure (MEP)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease (PD) | Abdominal Accesory Respiratory Muscles (rectus abdominis, transversus abdominis, and oblique muscles) and MIP(maximum inspiratory pressure) MEP(maximum expiratory pressure) values of the group with Parkinson's diagnosis and Hoehn Yahr Stage 1-2-3 will be measured, a 6-Minute Walk Test will be performed and the results will be noted. | |
| Control Group | Abdominal Accessory Respiratory Muscles (rectus abdominis, transversus abdominis, and oblique muscles) and MIP (maximum inspiratory muscles) MEP(maximum expiratory muscles) values of age and gender matched healthy values of age and gender matched healthy volunteers without any diagnosis of neuromuscular disease or chest diseases will be measured and the results will be noted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Expiratory Pressure (MEP) Measurement
MEP assesses the strength of abdominal and accessory expiratory muscles. During the maneuver, the patient is asked to blow forcefully into the mouthpiece for at least 1.5 seconds, as if inflating a balloon. The pressure generated during rapid expiration is measured by sensors, and after 1.5-2.0 seconds the shutter opens, ending the test. If multiple tests are conducted, the patient rests for at least 1 minute between trials, and a maximum of 3-5 trials are performed. Differences greater than 10 cmH₂O between trials are not accepted. The highest measurement is reported together with the predicted value. The MicroRPM Respiratory Pressure Meter (MicroDirect, USA) will be used.
Measured: to be measured only once at the start day 1
Maximal Inspiratory Pressure (MIP) Measurement
MIP is used to assess the strength of inspiratory respiratory muscles. During the test, the patient is instructed to exhale down to residual volume. MIP is defined as the maximum negative pressure measured during a maximal inspiratory effort performed after reaching residual volume. Measurements will be taken using the MicroRPM Respiratory Pressure Meter (MicroDirect, USA).
Measured: to be measured only once at the start day 1
Ultrasonographic Assessment of Abdominal Accessory Respiratory Muscles
Ultrasound measurements of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles will be performed. Measurements will be taken in the supine position with the patient lying on their back, eyes facing upward, arms resting symmetrically beside the trunk, and lower extremities in full knee extension with an intermalleolar distance of 10 cm. Muscle thickness will be recorded at the end of normal expiration and at the end of forced expiration.
Measured: to be measured only once at the start day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start29 Dec 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayşe Nur Sarıkoç, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308795
- Sponsor's protocol ID
- 2025-28
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasonographic Evaluation of Abdominal Accessory Respiratory Muscle Thickness in Patients With Parkinson's Disease: Correlation With Disease Severity and Expiratory Respiratory Muscle Strength
- ClinicalTrials.gov ID
- NCT07308795
- Acronym / sponsor ID
- 2025-28
- Conditions
- Parkinson Disease (PD), Maximum Inspiratory Pressure, Maximum Expiratory Pressure, Abdominal Accessory Respiratory Muscle Thickness
- Keywords
- abdominal muscles ultrasonography, parkinson disease, respiratory, MIP, abdominal muscles, respiratory muscles, expiratory muscle strenght, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients. In this study is to evaluate the thickness of abdominal accessory respiratory muscles using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined.
The study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength.
Detailed description
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients.
This observational, cross sectional study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength. In this study is to evaluate the thickness of abdominal accessory respiratory muscles (rectus abdominis, transversus abdominis, and oblique muscles) using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined. Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements. Disease severity will be evaluated using standardized clinical scales.
These findings will underscore the importance of evaluating respiratory muscles in Parkinson's disease and may contribute to the development of rehabilitation programs targeting respiratory muscles in the later stages of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease (PD) | – | –Abdominal Accesory Respiratory Muscles (rectus abdominis, transversus abdominis, and oblique muscles) and MIP(maximum inspiratory pressure) MEP(maximum expiratory pressure) values of the group with Parkinson's diagnosis and Hoehn Yahr Stage 1-2-3 will be measured, a 6-Minute Walk Test will be performed and the results will be noted. |
| Control Group | – | –Abdominal Accessory Respiratory Muscles (rectus abdominis, transversus abdominis, and oblique muscles) and MIP (maximum inspiratory muscles) MEP(maximum expiratory muscles) values of age and gender matched healthy values of age and gender matched healthy volunteers without any diagnosis of neuromuscular disease or chest diseases will be measured and the results will be noted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- THE GROUP WITH PARKINSON'S DIAGNOSIS AND HOEHN YAHR STAGE 1-2-3
Key inclusion criteria (4 listed)
- Age > 18 years
- Parkinson's disease diagnosis with Modified Hoehn and Yahr stages 1-2-3
- Mini-Mental State Examination (MMSE) score > 23
- Body Mass Index (BMI) < 30
Key exclusion criteria (6 listed)
- Active smokers
- Individuals with a diagnosis of active chest disease
- Those with hemodynamic instability
- Individuals with unstable vital signs
- Parkinson's patients who cannot be controlled with medical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal Expiratory Pressure (MEP) Measurement
Time frame: to be measured only once at the start day 1
MEP assesses the strength of abdominal and accessory expiratory muscles. During the maneuver, the patient is asked to blow forcefully into the mouthpiece for at least 1.5 seconds, as if inflating a balloon. The pressure generated during rapid expiration is measured by sensors, and after 1.5-2.0 seconds the shutter opens, ending the test. If multiple tests are conducted, the patient rests for at least 1 minute between trials, and a maximum of 3-5 trials are performed. Differences greater than 10 cmH₂O between trials are not accepted. The highest measurement is reported together with the predicted value. The MicroRPM Respiratory Pressure Meter (MicroDirect, USA) will be used.
Maximal Inspiratory Pressure (MIP) Measurement
Time frame: to be measured only once at the start day 1
MIP is used to assess the strength of inspiratory respiratory muscles. During the test, the patient is instructed to exhale down to residual volume. MIP is defined as the maximum negative pressure measured during a maximal inspiratory effort performed after reaching residual volume. Measurements will be taken using the MicroRPM Respiratory Pressure Meter (MicroDirect, USA).
Ultrasonographic Assessment of Abdominal Accessory Respiratory Muscles
Time frame: to be measured only once at the start day 1
Ultrasound measurements of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles will be performed. Measurements will be taken in the supine position with the patient lying on their back, eyes facing upward, arms resting symmetrically beside the trunk, and lower extremities in full knee extension with an intermalleolar distance of 10 cm. Muscle thickness will be recorded at the end of normal expiration and at the end of forced expiration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and privacy considerations.
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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.
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 Disease (PD) and Maximum Inspiratory Pressure, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYŞE NUR SARIKOÇ (+905412105141, aysenuryigit885@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Expiratory Pressure (MEP) Measurement (time frame: to be measured only once at the start day 1). The study lists 3 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 2 Jan 2026.