Clinical trial NCT05687799: Fatigue, Sleep and Quality of Life in Parkinson's Patients
Official title: The Relationship of Neutrophil/Lymphocyte Ratio With Fatigue, Sleep and Quality of Life in Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease
Quality of life
Neutrophil/Lymphocyte ratio
Quality of sleep
Fatigue
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.

Brief summary: Parkinson's Disease (PD) is a neurodegenerative disease characterized by chronic and progressive loss of dopaminergic neurons in the substantia nigra (SN) pars compacta. Sleep disturbances and fatigue are very common problems in Parkinson's patients. He reported that the frequency of fatigue was 47% in patients with a disease duration of less than five years and 70% in patients with a disease duration of more than five years. Fatigue in PD has been found to be associated with decreased physical activity, decreased functionality, sleep disorders, gait disturbances, motor findings, autonomic findings, increased levodopa dose, and motor fluctuations. Motor and non-motor symptoms in Parkinson's patients affect the individual's ability to perform activities of daily living independently. Impairments in functional status lead to negative consequences on quality of life. PD affects the individual not only physically, but also psychologically and socially.The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to quality of sleep, quality of life and fatigue in individuals is unclear. The aim of this study was to investigation fatigue, quality of sleep and quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients.

Detailed description: Parkinson's Disease (PD) is a neurodegenerative disease characterized by chronic and progressive loss of dopaminergic neurons in the substantia nigra (SN) pars compacta. Sleep disturbances and fatigue are very common problems in Parkinson's patients. He reported that the frequency of fatigue was 47% in patients with a disease duration of less than five years and 70% in patients with a disease duration of more than five years. Fatigue in PD has been found to be associated with decreased physical activity, decreased functionality, sleep disorders, gait disturbances, motor findings, autonomic findings, increased levodopa dose, and motor fluctuations. Motor and non-motor symptoms in Parkinson's patients affect the individual's ability to perform activities of daily living independently. Impairments in functional status lead to negative consequences on quality of life. PD affects the individual not only physically, but also psychologically and socially.The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to quality of sleep, quality of life and fatigue in individuals is unclear. The aim of this study was to investigation fatigue, quality of sleep and quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients.The aim of this study was to investigation fatigue, quality of sleep and quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients. A total of 39 Parkinson's Disease age of older the 50 participate in the research.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with idiopathic Parkinson's disease
* Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
* Older than 50 years old
* Volunteer to participate in the study
* Grade 1-3 on the Modified Hoehn-Yahr Scale
* To have a score above 24 in the Standardized Mini Mental Test
* To have a hemogram follow-up in the last 1 month before the date of participation in the study.
* Being able to walk independently on flat ground

Exclusion Criteria:

* Having an additional or psychiatric disease other than Parkinson's disease
* Lack of cooperation
* Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)

Primary outcomes:
measure: Parkinson's Disease Quality of Life-8
timeFrame: Baseline
measure: Hemogram
timeFrame: Baseline
measure: Parkinson's Fatigue Scale-16
timeFrame: Baseline
measure: The Parkinson's Disease Sleep Scale
timeFrame: Baseline
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Baseline
measure: Modified Hoehn and Yahr Scale
timeFrame: Baseline
Other outcomes:
measure: Standardized Mini Mental Test
timeFrame: Baseline
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University Treaning and Research Hospital
Study officials:
affiliation: Nigde Omer Halisdemir University Treaning and Research Hospital
name: Dilek İŞCAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References: