NCT07010783

Brief Summary

The aim is to examine respiratory functions, inspiratory muscle strength, respiratory function, physical fitness and aerobic capacity in Parkinson's disease patients. Individuals between the ages of 50-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. In addition, patients will be divided into three groups as above and below 2.5 and healthy controls according to the Modified Hoehn and Yahr Scale. Demographic information of the individuals will be recorded and clinical evaluations will be made. The staging of Parkinson's patients will be done with the Modified Hoehn and Yahr Scale, and the severity of the disease will be done with the Unified Parkinson's Disease Rating Scale. The inspiratory muscle strength of the individuals will be evaluated with the PowerBreath K5, respiratory functions with the Pulmonary Function Test device, and physical fitness and aerobic capacity with the Senior Fitness Test.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 24, 2026

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 30, 2025

Last Update Submit

March 22, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Inspiratory Muscle Strength Measurement

    In this study, the inspiratory muscle strength of the participants will be measured using the Power Breath device.

    Baseline

  • Unified Parkinson's Disease Rating Scale

    This scale will evaluate the severity and stage of the participants' Parkinson's disease.

    Baseline

  • Evaluation of Respiratory Functions

    Participants' respiratory functions will be evaluated using a standard respiratory function test device.

    Baseline

  • Senior Fitness Test

    The physical fitness levels of the participants will be evaluated using the Senior Fitness Test.

    Baseline

Study Arms (3)

Early Stage Patients with Parkinson's Disease

According to the Modified Hoehn and Yahr Scale (MHÖ), patients with a score below 2.5

Advanced Stage Patients with Parkinson's Disease

According to the Modified Hoehn and Yahr Scale (MHÖ), patients with 2.5 and above

Control Group

Healthy individuals with similar demographic characteristics

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease who came to the neurology outpatient clinic for routine examination and who met the appropriate inclusion criteria and healthy individuals with similar demographic characteristics.

You may qualify if:

  • Age 50 to 80
  • Mini Mental State Examination score of 24 to 30
  • Diagnosed with Parkinson's Disease by a neurologist

You may not qualify if:

  • Sözlü iletişim kuramama
  • Yürüme yardımcısı kullanıma
  • Ciddi görme bozukluğu, ek nörolojik bozuklukları ve/veya konjestif kalp yetmezliği olan yaşlılar
  • Egzersiz yapılması tavsiye edilmeyen yaşlı yetişkinler.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Shill H, Stacy M. Respiratory function in Parkinson's disease. Clin Neurosci. 1998;5(2):131-5.

  • Morris ME, Iansek R, Matyas TA, Summers JJ. Ability to modulate walking cadence remains intact in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1994 Dec;57(12):1532-4. doi: 10.1136/jnnp.57.12.1532.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Süleyman Korkusuz, PhD

    Atılım University

    STUDY CHAIR
  • Ayla Fil Balkan, Assoc Prof

    Hacettepe University

    STUDY CHAIR
  • Gül Yalçın Çakmaklı, Assoc Prof

    Hacettepe University

    STUDY CHAIR
  • Neslihan Durutürk, Prof.Dr

    Baskent University

    STUDY CHAIR

Central Study Contacts

Büşra Seçkinoğulları Korkusuz, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

July 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 24, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations