NCT06008444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

August 21, 2023

Last Update Submit

May 16, 2025

Conditions

Keywords

painchest mobilitycoughmuscle strengthphysical activityquality of life

Outcome Measures

Primary Outcomes (1)

  • Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire.

    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.

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • Cough Strength

    through study completion, an average of 1 year

  • Daily average step count

    through study completion, an average of 1 year

  • Hand grip strength

    through study completion, an average of 1 year

  • Chest mobility

    through study completion, an average of 1 year

  • Cognitive status

    through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

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.

Post-COVID-19 group

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (2)

  • Shalash A, Helmy A, Salama M, Gaber A, El-Belkimy M, Hamid E. A 6-month longitudinal study on worsening of Parkinson's disease during the COVID-19 pandemic. NPJ Parkinsons Dis. 2022 Aug 31;8(1):111. doi: 10.1038/s41531-022-00376-x.

    PMID: 36045133BACKGROUND
  • Shalash A, Roushdy T, Essam M, Fathy M, Dawood NL, Abushady EM, Elrassas H, Helmi A, Hamid E. Mental Health, Physical Activity, and Quality of Life in Parkinson's Disease During COVID-19 Pandemic. Mov Disord. 2020 Jul;35(7):1097-1099. doi: 10.1002/mds.28134. Epub 2020 Jun 7. No abstract available.

    PMID: 32428342BACKGROUND

MeSH Terms

Conditions

Parkinson DiseasePainCoughMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryBehavior

Study Officials

  • GÜLŞAH BARĞI

    Izmir Democracy University

    STUDY DIRECTOR
  • MERVE ŞAHİN

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • ÖZLEM ÇİNAR ÖZDEMİR

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • YASEMİN ÜNAL

    Bandirma Health Practice and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 23, 2023

Study Start

May 13, 2023

Primary Completion

August 30, 2024

Study Completion

December 30, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations