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NCT Number: 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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştirma Hastanesi

Istanbul, BAHÇELİEVLER, 34180, Turkey (Türkiye)

Location status: Recruiting

Location contact

İSTANBUL FİZİK TEDAVİ VE REHABİLİTASYON EAH İSTANBUL FİZİK TEDAVİ VE REHABİLİTASYON EAH

CONTACT

[email protected]

0(212) 496 50 00

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Other outcomes

  1. Six Minute Walk Test (6MWT)

    Time frame: to be measured only once at the start day 1

    The 6MWT is performed in a corridor with a flat, firm surface that is at least 30 meters long and marked at 3-meter intervals. Turning points should be indicated with a colored object. Start and finish lines are designated. The patient is asked to walk the longest distance possible within 6 minutes. The distance walked is measured and recorded.

  2. Modified Hoehn and Yahr Staging

    Time frame: to be measured only once at the start day 1

    This scale, developed by Margaret Hoehn and Melvin Yahr in 1967, is used to determine the severity of Parkinson's disease. It evaluates patient functionality, symptom laterality, pattern of involvement, and balance. The scoring ranges from 1 to 5. The Modified Hoehn & Yahr staging system includes additional stages 1.5 and 2.5. As the stage progresses, symptoms become more widespread, balance impairment and functional limitation increase; in the later stages, the patient becomes dependent on assistance or care.

Study contacts

Contact information is provided by the study sponsor or research team.

AYŞE NUR SARIKOÇ

CONTACT

[email protected]

+905412105141

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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