Parkinson DiseaseNCT07014514
Severity of Sarcopenia in Parkinson's Disease
An observational study of Parkinson Disease, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 25 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Sarcopenia Severity in Patients With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Keywords
- sarcopenia, ultrasonography
- Medical subject headings
- Parkinson Disease, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Measurement
For sarcopenia evaluation, anterior thigh muscle thickness will be measured by ultrasonography.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start20 Jun 2025
- Primary completion20 Sep 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Süleyman Korkusuz, PhD, Study chair, Atılım UniversityAyla Fil Balkan, Assoc Prof, Study chair, Hacettepe UniversityGül Yalçın Çakmaklı, Assoc Prof, Study chair, Hacettepe UniversityBüşra Seçkinoğulları Korkusuz, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014514
- Sponsor's protocol ID
- E-59394181-604.01-112205
- Status last verified
- Jul 2025
- First submitted
- 30 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24737557Kara 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.
PubMed 34121127
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sarcopenia Severity in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07014514
- Acronym / sponsor ID
- E-59394181-604.01-112205
- Conditions
- Parkinson Disease
- Keywords
- sarcopenia, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasonographic Measurement
Time frame: Baseline
For sarcopenia evaluation, anterior thigh muscle thickness will be measured by ultrasonography.
Five Times Sit to Stand Test
Time frame: Baseline
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.
Hand Grip Strength
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 24737557Studenski 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.
- Results publication: PubMed 34121127Kara 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Süleyman Korkusuz, PhD study chair
Atılım University
Ayla Fil Balkan, Assoc Prof study chair
Hacettepe University
Gül Yalçın Çakmaklı, Assoc Prof study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Measurement (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.