Clinical trial NCT06230939: Examination of Factors Associated With Fatigue in Individuals Diagnosed With Parkinson's Disease
Official title: Examination of Factors Associated With Fatigue in Individuals Diagnosed With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Fatigue
Keywords: Parkinson's disease
Fatigue
Examination
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-01-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Parkinson Fatigue Scale-16 (PFS-16);
timeFrame: Baseline
measure: Hospital Anxiety and Depression Survey (HAD)
timeFrame: Baseline
measure: Parkinson's Disease Sleep Scale-2 (PDSS-2)
timeFrame: Baseline
measure: Time Up and Go Test (TUG)
timeFrame: Baseline
Secondary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline
measure: Modified Hoehn-Yahr Evaluation (MHYE)
timeFrame: Baseline
measure: Interview Form
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Gazi University
name: İlke KESER, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.