Clinical trial NCT07014514: Severity of Sarcopenia in Parkinson's Disease
Official title: Investigation of Sarcopenia Severity in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: sarcopenia
ultrasonography
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

Brief summary: The aim of the study is to examine the severity of sarcopenia in Parkinson's disease patients. Patients between the ages of 40-75 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. 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. Within the scope of the study, anterior thigh thicknesses of individuals with Parkinson's disease will be evaluated with ultrasonography. Sarcopenia severity will be determined with the ISarcoPRM algorithm using the ultrasonographic evaluations of the individuals. It is planned to include 80 Parkinson's patients in the study. Parkinson's patients between stages 1-3 according to the Modified Hoehn and Yahr Scale will be included in the study.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ultrasonographic Measurement
timeFrame: Baseline
measure: Five Times Sit to Stand Test
timeFrame: Baseline
measure: Hand Grip Strength
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
affiliation: Atılım University
name: Süleyman Korkusuz, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ayla Fil Balkan, Assoc Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Gül Yalçın Çakmaklı, Assoc Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.