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

NCT ID: NCT06230939

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2025-11-05

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.

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.

Conditions

Parkinson Disease; Fatigue

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Examination

Intervention Type: 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.

Interventions

Examination

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Asli Demirtaş

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlke KESER, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Nigde Omer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28954481 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27751556 (View on PubMed)

Other Identifiers

Gazi University-05.09.2023.3

Identifier Type: -

Identifier Source: org_study_id