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

Parkinson Disease Clinical Trial

Official title:

Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008444
• Other study ID #: Effects of COVID on Parkinson
• Status: Recruiting
• Start date: May 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Izmir Democracy University
• Contact: GÜLSAH BARGI
• Phone: +90 232 299 0739
• Email: gulsahbargi35[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Parkinson Disease
• Respiratory Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Izmir Democracy University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Democracy University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cough Strength	Cough Strength will be evaluated using a Peak Flow Meter.	through study completion, an average of 1 year
Secondary	Daily average step count	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.	through study completion, an average of 1 year
Secondary	Hand grip strength	Hand grip strength will be evaluated using a hand dynamometer.	through study completion, an average of 1 year
Secondary	Chest mobility	Chest mobility will be evaluated using a tape measure.	through study completion, an average of 1 year
Secondary	Cognitive status	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.	through study completion, an average of 1 year