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Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19

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ClinicalTrials.gov Identifier: NCT06008444
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : December 19, 2023
Sponsor:
Information provided by (Responsible Party):
Gulsah Bargi, Izmir Democracy University

Study Description
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Brief Summary:
To comparative pain intensity, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with post-COVID-19 and without post-COVID-19 was aimed in current study. Knowledge in the literature regarding this topic is still obscure.

Condition or disease Intervention/treatment
COVID-19 Respiratory Infection Parkinson Disease Other: Physical Evaluations of post-COVID-19 individuals Other: Physical Evaluations of non-post-COVID-19 individuals

Detailed Description:
Acute worsening and long-term sequelae of motor and non-motor symptoms have also been described in Parkinson's patients during and after SARS-CoV-2 infection, which is also known as prolonged COVID. The effects of COVID-19 on pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients are still unclear today. For this reason, in this study, it was aimed to comparatively investigate pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with COVID-19 and without COVID-19 and to show the relationships between these outcome measures.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19
Actual Study Start Date : May 13, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Post-COVID-19 group
This group will consist of individuals with Parkinson disease who have had COVID-19.
 Other: Physical Evaluations of post-COVID-19 individuals
In this research, the data of Parkinson's patients who have had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.
Control group
The control group will consist of individuals with Parkinson disease without post-COVID-19.
 Other: Physical Evaluations of non-post-COVID-19 individuals
In this research, the data of Parkinson's patients who have not had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.


Outcome Measures
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Primary Outcome Measures :
  1. Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire. [ Time Frame: through study completion, an average of 1 year ]
    The status of quality of life will be evaluated using Parkinson's Disease Questionnaire (PDQ-39) questionnaire. Parkinson's Disease Questionnaire-39 (PDQ39) is a 39-item quality of life questionnaire. Evaluation for each question item ranges from 0 (no problem) to 4 (constant problem). Low scores in total indicate an improvement in people's quality of life.


Secondary Outcome Measures :
  1. Cough Strength [ Time Frame: through study completion, an average of 1 year ]
    Cough Strength will be evaluated using a Peak Flow Meter.

  2. Daily average step count [ Time Frame: through study completion, an average of 1 year ]
    Daily average step counts will be recorded via a pedometer everyday within 3 days after confirming enrolment. All individuals will be asked to carry their pedometers with them during the day and record to their diaries.

  3. Hand grip strength [ Time Frame: through study completion, an average of 1 year ]
    Hand grip strength will be evaluated using a hand dynamometer.

  4. Chest mobility [ Time Frame: through study completion, an average of 1 year ]
    Chest mobility will be evaluated using a tape measure.

  5. Cognitive status [ Time Frame: through study completion, an average of 1 year ]
    Cognitive state will be evaluated using The mini-mental state examination (MMSE). It is an 11 question test. The highest score from the test is 30 points. Scores of 23 and lower indicate cognitive dysfunction, and scores of 24 and higher indicate normal cognitive level.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
At least 21 Parkinson's patients with post-COVID-19 will be included in the main group and at least 11 Parkinson's patients without post-COVID-19 will be included in control group.
Criteria

Inclusion Criteria for Parkinson's patients with post-COVID-19;

  • Being diagnosed with COVID-19 at least 12 weeks ago and recovered,
  • Being over 18 years old,
  • Volunteering to participate in the research,
  • Being diagnosed with Parkinson's disease
  • Comorbid conditions (such as hypertension, diabetes) are under control
  • Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
  • Having the ability to ambulate and walk independently
  • Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Inclusion criteria for Parkinson's patients without post-COVID-19;

  • Not being diagnosed or suspected of COVID-19
  • Being over 18 years old,
  • Volunteering to participate in the research,
  • Being diagnosed with Parkinson's disease
  • Having comorbid conditions (such as hypertension, diabetes) which are under control
  • Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
  • Having the ability to ambulate and walk independently
  • Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Exclusion criteria for Parkinson's patients with and without post-COVID-19;

  • Sudden drug or dose change during the study period
  • A history of any acute/chronic orthopedic, cardiovascular, pulmonary, psychiatric or neuromuscular disease that may prevent measurements from being made.
  • Having had myocardial infarction and pulmonary embolism in the last 30 days,
  • Having a history of additional neurological (stroke, head trauma, peripheral nerve diseases, brain and spinal cord tumors, etc.) diseases other than Parkinson's disease
  • Having severe vision loss or vestibular dysfunction
  • Patients with blood pressure values above 140/90 and below 90/50 in blood pressure measurements made before the study, with arrhythmia on ECG, with a history of shortness of breath and/or palpitation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008444


Contacts
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Contact: GÜLŞAH BARĞI +90 232 299 0739 gulsahbargi35@gmail.com
Contact: MERVE ŞAHİN

Locations
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Turkey
Izmir Democracy University Recruiting
İzmir, Turkey, 35140
Contact: GÜLŞAH BARĞI, PHD    +905317938766    gulsah.bargi@idu.edu.tr   
Sponsors and Collaborators
Izmir Democracy University
Investigators
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Study Director: GÜLŞAH BARĞI Izmir Democracy University
Principal Investigator: MERVE ŞAHİN Izmir Democracy University
Principal Investigator: ÖZLEM ÇİNAR ÖZDEMİR Izmir Democracy University
Principal Investigator: YASEMİN ÜNAL Bandirma Health Practice and Research Hospital
More Information
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Publications:

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Responsible Party: Gulsah Bargi, Principal Investigator, Izmir Democracy University
ClinicalTrials.gov Identifier: NCT06008444    
Other Study ID Numbers: Effects of COVID on Parkinson
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: December 19, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gulsah Bargi, Izmir Democracy University:
pain
chest mobility
cough
 muscle strength
physical activity
quality of life
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Parkinson Disease
Pneumonia, Viral
Pneumonia
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases