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

NCT06230939 | Completed DMC

• 1 other identifier: Gazi University-05.09.2023.3
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Fatigue; Parkinson Disease

Keywords

Parkinson's disease; Fatigue; Examination

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (4)

• Mini Mental State Examination (MMSE)

  Baseline

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Baseline

• Modified Hoehn-Yahr Evaluation (MHYE)

  Baseline

• Interview Form

  Baseline

Study Arms (1)

Parkinson's Disease Group

The 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.

Other: Examination

Interventions

Examination OTHER

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.

Parkinson's Disease Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Gazi University: collaborator

Study Sites (2)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

Nigde Omer Halisdemir University

Niğde, 51200, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28954481 BACKGROUND

• 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.

  PMID: 27751556 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• İlke KESER, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: November 5, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)