Clinical trial NCT06008444: Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19
Official title: Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Parkinson Disease
Keywords: pain
chest mobility
cough
muscle strength
physical activity
quality of life
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Cough Strength
timeFrame: through study completion, an average of 1 year
measure: Daily average step count
timeFrame: through study completion, an average of 1 year
measure: Hand grip strength
timeFrame: through study completion, an average of 1 year
measure: Chest mobility
timeFrame: through study completion, an average of 1 year
measure: Cognitive status
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: GÜLŞAH BARĞI
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: MERVE ŞAHİN
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: ÖZLEM ÇİNAR ÖZDEMİR
role: PRINCIPAL_INVESTIGATOR
affiliation: Bandirma Health Practice and Research Hospital
name: YASEMİN ÜNAL
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.