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

April 3, 2023 updated by: Asli Celik, Nigde Omer Halisdemir University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Niğde, Turkey, 51200
        • Nigde Omer Halisdemir University Treaning and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Quality of Life-8
Time Frame: Baseline
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
Hemogram
Time Frame: Baseline
The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.
Baseline
Parkinson's Fatigue Scale-16
Time Frame: Baseline
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
The Parkinson's Disease Sleep Scale
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Hoehn and Yahr Scale
Time Frame: Baseline

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
Unified Parkinson's Disease Rating Scale
Time Frame: Baseline
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini Mental Test
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Investigators

  • Principal Investigator: Dilek İŞCAN, Dr., Nigde Omer Halisdemir University Treaning and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Actual)

March 22, 2023

Study Completion (Actual)

March 22, 2023

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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