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Parkinson DiseaseNCT06230939

Examination of Factors Associated With Fatigue in Individuals Diagnosed With Parkinson's Disease

An observational study of Parkinson Disease and Fatigue, run by Nigde Omer Halisdemir University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fatigue is defined as an overwhelming feeling of weariness, lack of energy, and a feeling of exhaustion. It is common in Parkinson's Disease (PD) and is one of the most disabling symptoms. Fatigue is affected by motor and non-motor symptoms in individuals diagnosed with PD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Fatigue
What is being tested?
Examination
How many people
129 participants
Where
2 sitesTurkey (Türkiye)
Study dates
5 Nov 2023to 5 Nov 2025
How long will I take part?
2 Years
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The research will be carried out in cooperation with Gazi University Faculty of Health Sciences and Nigde Omer Halisdemir University. Study data will be obtained from individuals diagnosed with PD who apply to Nigde Omer Halisdemir University Training and Research Hospital Neurology Polyclinic. Necessary permissions were obtained from all institutions.

Who may be able to join

  • Being 18 years or older,
  • Being diagnosed with PD by a neurologist,
  • Having stable medical treatment,
  • Being able to stand independently for at least 60 seconds without any assistive device,
  • Having received 18 points or more according to the MMSD evaluation.

Who cannot join

  • Being illiterate or unable to communicate in Turkish,
  • Having undergone a surgery that may affect lower extremity functions,
  • Diabetes mellitus is a diagnosis of another neurological and rheumatic disease.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Gazi University

    Ankara, 06490

  • Nigde Omer Halisdemir University

    Niğde, 51200

Other trials in Turkey (Türkiye)

About this study

Fatigue is defined as an overwhelming feeling of weariness, lack of energy, and a feeling of exhaustion. It is common in Parkinson's Disease (PD) and is one of the most disabling symptoms. Fatigue is affected by motor and non-motor symptoms in individuals diagnosed with PD. As a result of this impact, it manifests itself as difficulty in initiating and continuing mental and physical tasks. This study aims to examine the fatigue of individuals diagnosed with PD and the factors associated with this fatigue.

Read the detailed description

The study will be carried out in cooperation with Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation and Nigde Omer Halisdemir University, and the study data will be collected from individuals diagnosed with PD who applied to the Neurology Polyclinic of Nigde Omer Halisdemir University Training and Research Hospital. Necessary permissions have been obtained from all institutions. Modified Hoehn\&Yahr staging (HYS) and Unified Parkinson's Disease Rating Scale (UPDRS and its subtests) will be used for disease staging and grading. Parkinson's Fatigue Scale-16 (PFS-16) to evaluate fatigue, Parkinson's Disease Sleep Scale-2 (PDSS-2) to evaluate sleep, Hospital Anxiety and Depression Scale (HAD) to evaluate depression and anxiety, Mini-Mental to evaluate cognitive status (MMSE) will be used. In addition, "Timed Up and Go (TUG)" will be applied for lower extremity performance evaluation. All evaluations will be collected in a single meeting using the face-to-face interview method. It is calculated that 80% power will be reached with a margin of error of 0.05 when 84 individuals diagnosed with PD are included in the study.

Being tested
Examination
Keywords
Parkinson's disease, Fatigue, Examination
Medical subject headings
Parkinson Disease, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExaminationOther

    Individual characteristics of the patients (gender, age, height, body weight, marital status, education level, dominant extremity, smoking and alcohol consumption habits, use and type of assistive device, how many years the assistive device has been used) and disease-related (year of diagnosis, disease duration Information (such as CV, family history, medications used, surgeries) will be questioned. HYE and UPDRS will be used for disease staging and grading. PFS-16 will be used to evaluate fatigue and MMSE will be used to evaluate sleep. In addition, "Timed Up and Go (TUG)" will be applied for lower extremity performance evaluation. All evaluations will be collected in a single meeting using the face-to-face interview method.

Study groups in NCT06230939
Study groupRoleWhat they receive
Parkinson's Disease GroupThe study will be conducted in collaboration with Gazi University Faculty of Health Sciences and Nigde Omer Halisdemir University. The study data will be obtained from individuals diagnosed with PD admitted to the Neurology Outpatient Clinic of Nigde Omer Halisdemir University Training and Research Hospital. Necessary permissions were obtained from all institutions. All evaluations will be collected in a single meeting using the face-to-face interview method. It is calculated that 80% power will be reached with a margin of error of 0.05 when 84 individuals diagnosed with PD are included in the study.
Receives: Other: Examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parkinson Fatigue Scale-16 (PFS-16);

    PFS-16, consists of 16 items designed to evaluate the impact of fatigue on daily life and its physical dimensions. The scale allows measuring the presence of fatigue (7 items) and its impact on daily function (9 items). Individuals are asked to respond to statements about fatigue on a 5-point Likert scale between 1 (strongly disagree) and 5 (strongly agree).

    Measured: Baseline

  2. Hospital Anxiety and Depression Survey (HAD)

    Each item of the scale, which consists of 14 items, is scored between 0 and 3. For anxiety and depression values, 0-7 points are considered normal, 8-10 points are considered borderline, and 11 points and above are considered abnormal. The validity and reliability of this scale in Turkish has been established.

    Measured: Baseline

  3. Parkinson's Disease Sleep Scale-2 (PDSS-2)

    The scale is a 5-point Likert type (4: Very often, 6-7 days a week; 3: Frequently, 4-5 days a week; 2: Sometimes, 2-3 days a week; 1: Occasionally, 1 day a week; 0: Never) consists of 15 items. The scale includes general night sleep quality (item 1), falling asleep (item 2), insomnia (item 3), night restlessness (items 4 and 5), night psychosis (items 6 and 7), nocturia (item 8). . and items 9), night motor symptoms (items 10, 11, 12 and 13), waking up rested (item 14) and sleep-disordered breathing (item 15) are evaluated.

    Measured: Baseline

  4. Time Up and Go Test (TUG)

    Timed get up and go test is used for functional evaluation of patients. This test is important in terms of evaluating patients' walking speed as well as testing their ability to maintain balance. In the test application, after the patient gets up from the chair without back support, he walks three meters to the marked area, turns back, and on the way back, the time to sit on the chair is calculated by walking three meters again. The test is repeated three times and the average in seconds is recorded.

    Measured: Baseline

Secondary outcomes (4)

  1. Mini Mental State Examination (MMSE)

    MMSE will be used to evaluate cognitive functions. The mini mental test is categorized under five main headings. It consists of 11 items including orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). It is evaluated over 30 points in total. A score between 24-30 points is defined as normal, 18-23 points as mild dementia, and 17 points and below as severe dementia. The average administration time of the test is 10 minutes. Patients scoring 18 and above will be included in the study.

    Measured: Baseline

  2. Unified Parkinson's Disease Rating Scale (UPDRS)

    Unified Parkinson's Disease Rating Scale (UPDRS) is a scale created to evaluate the motor performance, mental and spiritual status, and daily life activities of patients diagnosed with PD. The scale consists of a total of 4 sections and 42 items. In the first part, non-motor symptoms such as thoughts, behavior and affect; In the second part, activities of daily living; motor symptoms in the third part; In the fourth section, treatment complications are evaluated. Each item is scored between 0 (no symptoms or signs) and 4 (the most severe symptom or sign possible).

    Measured: Baseline

  3. Modified Hoehn-Yahr Evaluation (MHYE)

    Modified Hoehn-Yahr Evaluation (MHYE) used to define the disease stage of patients diagnosed with PD. According to MHYE, the disease consists of 8 stages. It is stated that the disease symptoms worsen as the stage progresses.

    Measured: Baseline

  4. Interview Form

    All evaluations will be carried out by face-to-face interview method. Individual characteristics of the patients (gender, age, height, body weight, marital status, education level, dominant extremity, smoking and alcohol consumption habits, use and type of assistive device, how many years the assistive device has been used) and disease-related (year of diagnosis, disease duration Information (such as CV, family history, medications used, surgeries) will be questioned.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start5 Nov 2023
  3. Primary completion5 Nov 2025
  4. Study completion5 Nov 2025

Resources

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
Case only
Time perspective
Prospective
Enrolment
129 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230939
Sponsor's protocol ID
Gazi University-05.09.2023.3
Status last verified
Jan 2026
First submitted
19 Jan 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Opara J, Malecki A, Malecka E, Socha T. Motor assessment in Parkinson;s disease. Ann Agric Environ Med. 2017 Sep 21;24(3):411-415. doi: 10.5604/12321966.1232774. Epub 2017 May 11.

    PubMed 28954481

  • Ascherio A, Schwarzschild MA. The epidemiology of Parkinson's disease: risk factors and prevention. Lancet Neurol. 2016 Nov;15(12):1257-1272. doi: 10.1016/S1474-4422(16)30230-7. Epub 2016 Oct 11.

    PubMed 27751556

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Fatigue, run by Nigde Omer Halisdemir University at 2 sites 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 5 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Parkinson Fatigue Scale-16 (PFS-16); (time frame: Baseline). The study lists 4 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 NCT06230939, 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 27 Jan 2026.

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