Fatigue, Sleep and Quality of Life in Parkinson's Patients

Idiopathic Parkinson's Disease Clinical Trial

Official title:

The Relationship of Neutrophil/Lymphocyte Ratio With Fatigue, Sleep and Quality of Life in Parkinson's Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687799
• Other study ID #: 2022/108
• Status: Completed
• Start date: December 22, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: April 2023
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Idiopathic Parkinson's Disease
• Parkinson Disease

Locations

Country	Name	City	State
Turkey	Nigde Omer Halisdemir University Treaning and Research Hospital	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standardized Mini Mental Test	There are 19 items in this test, which consists of 5 main parts: orientation, recording memory, attention and calculation, recall and language. The total score of the test is evaluated out of 30 and 24 points are accepted as the threshold value for the diagnosis of mild dementia. The higher the score, the higher the cognition of individuals.	Baseline
Primary	Parkinson's Disease Quality of Life-8	One question from each of the eight domains in Parkinson's Disease Quality of Life-39, which are activities of daily living, physical discomfort, cognition, communication, emotional well-being, mobility, social support and stigma, gives the total domain score.Each question is scored between 0-4 points and points are added up. The total score is then divided by the total possible score and given as a percentage point out of 100. The lower the score, the higher the quality of life.	Baseline
Primary	Hemogram	The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.	Baseline
Primary	Parkinson's Fatigue Scale-16	The scale is the only fatigue scale specific to PD developed by Brown et al. It examines the impact of fatigue on daily life and consists of 16 items designed to assess the physical effects of fatigue. The scale allows to measure the presence of fatigue (seven items) and its effect on daily function (nine items). The subjects are asked to respond to the statements about fatigue between 1 (strongly disagree) and 5 (strongly agree). The higher score, the worsen fatigue scale in participant.	Baseline
Primary	The Parkinson's Disease Sleep Scale	Parkinson's Disease Sleep Scale consists of 15 questions to be answered by the patient. With this, the quality of sleep as a whole during the night, difficulty in starting and maintaining sleep, night restlessness, nocturnal psychosis, nocturia, nocturnal motor symptoms, restlessness of sleep and naps during the day can be evaluated. The test is done by giving a score between 0 (very severe complaints) and 10 (no complaints) for each question. The total score point is 150. Higher scores indicate better sleep quality.	Baseline
Secondary	Unified Parkinson's Disease Rating Scale	This scale was created to evaluate the motor performance, mental and mental status, and activities of daily living of Parkinson's patients. It also evaluates motor fluctuations, dyskinesias, and autonomic dysfunction. The scale was prepared as 4 parts and 42 items. When the extremities are evaluated separately, it increases up to 55 items. Items are rated from 0 (no symptoms or signs) to 4 (most severe symptoms and signs). The first part evaluates the non- motor features of the disease, such as thoughts, behaviors, and emotions. The second part consists of activities of daily living. In the third part, motor examination, in the fourth part, the complications of the treatment are given. It is used to evaluate the symptoms of the disease and the complications that develop due to treatment. In this scale, which consists of 4 parts, the scoring of each item is between 0-4 points. The increase in the total score reflects the increase in the severity of the symptoms.	Baseline
Secondary	Modified Hoehn and Yahr Scale	This staging scale was developed by Margaret Hoehn and Melvin Yahr (1967) for use in describing the stage of Parkinson's disease. According to the staging scale, the disease is handled in 8 stages. The lower the stage, the better of the stage Parkinson's disease.; Stage 0: No signs of disease Stage 1: Unilateral disease Stage 1.5: Unilateral plus axial involvement. Stage 2: Bilateral disease, no balance disorder. Stage 2.5: Mild bilateral disease recovering on pull test. Stage 3: Mild to moderate bilateral disease and some postural instability, physically independent.; Stage 4: Severe disability, able to stand and walk unaided. Stage 5: Unassisted wheelchair or bed dependent.	Baseline