NCT07014514

Brief Summary

This study aimed to determine the prevalence of sarcopenia and dynapenia in Parkinson's disease patients, classified into early-stage (\<2.5) and moderate-stage (≥2.5) according to the Modified Hoehn and Yahr scale, and healthy controls using the ICF-based ISarcoPRM algorithm, and to examine the differences in regional muscle morphology, muscle strength, and physical performance between groups.This study was conducted as a cross-sectional research. The study included 43 Parkinson's disease patients aged 50-75 years, classified as stages 1-3 according to the Modified Hoehn-Yahr Scale, and 22 healthy individuals with similar demographic characteristics. Parkinson's disease patients were divided into two subgroups according to the Modified Hoehn-Yahr Scale: early stage (\<2.5) and intermediate stage (≥2.5). Demographic information of all participants was recorded, and clinical evaluations were performed. Parkinson's disease staging was assessed using the Modified Hoehn-Yahr Scale. Muscle mass was assessed using ultrasonography to measure anterior femoral muscle thickness. Muscle strength was measured by handgrip strength, and physical performance was assessed using a five-count sit-up test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
Last Updated

March 25, 2026

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

May 30, 2025

Last Update Submit

March 22, 2026

Conditions

Keywords

sarcopeniaultrasonography

Outcome Measures

Primary Outcomes (3)

  • Ultrasonographic Measurement

    For sarcopenia evaluation, anterior thigh muscle thickness will be measured by ultrasonography.

    Baseline

  • Five Times Sit to Stand Test

    This test measures the time it takes for an individual to stand up and sit down 5 times as quickly as possible, starting from a sitting position without using their arms.

    Baseline

  • Hand Grip Strength

    In this test, the individual will sit on a chair with their feet flat on the floor. The Jamar Hand Dynamometer will be used for measurement. They will be asked to squeeze the dynamometer firmly with their shoulders adducted and in neutral rotation, their elbows in 90-degree flexion, their forearms neutral and supported, and their wrists neutral. 3 repetitions will be done and the average will be taken.

    Baseline

Study Arms (3)

Early Stage

Patients with Early Stage Parkinson's Disease

Control Group

Healthy individuals with similar demographic characteristics

Moderate Stage

Patients with Moderate Stage Parkinson's Disease

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Among the patients diagnosed with Parkinson's Disease who come to the neurology clinic for routine examination, patients who meet the appropriate inclusion criteria will be evaluated by the Neurology Specialist and included in the study.

You may qualify if:

  • Score between 24 and 30 on the Mini Mental State Examination
  • Be diagnosed with Parkinson's Disease by a neurologist
  • Stage 1-3 on the Modified Hoehn and Yahr Scale

You may not qualify if:

  • Inability to communicate verbally
  • Elderly people with severe visual impairment, neurological disorders in addition to Parkinson's and/or congestive heart failure
  • Older adults in whom exercise is not recommended

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.

  • Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.

MeSH Terms

Conditions

Parkinson DiseaseSarcopenia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

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
  • Büşra Seçkinoğulları Korkusuz, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR

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 11, 2025

Study Start

June 20, 2025

Primary Completion

September 20, 2025

Study Completion

October 25, 2025

Last Updated

March 25, 2026

Record last verified: 2025-07

Locations