NCT07308795

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 29, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 8, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

abdominal muscles ultrasonographyparkinson diseaserespiratoryMIPabdominal musclesrespiratory musclesexpiratory muscle strenghtultrasoundmaximum expiratory pressure (MEP)

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    to be measured only once at the start day 1

Other Outcomes (2)

  • Six Minute Walk Test (6MWT)

    to be measured only once at the start day 1

  • Modified Hoehn and Yahr Staging

    to be measured only once at the start day 1

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

THE GROUP WITH PARKINSON'S DIAGNOSIS AND HOEHN YAHR STAGE 1-2-3

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi

Istanbul, BAHÇELİEVLER, 34180, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 30, 2025

Study Start

December 29, 2025

Primary Completion

February 28, 2026

Study Completion

April 20, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and privacy considerations.

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