Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000564651
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
25/05/2023
Date last updated
25/05/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson’s Patients with post-COVID-19
Scientific title
Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson’s Patients who have had COVID-19
Secondary ID [1] 309409 0
Nil known
Universal Trial Number (UTN)
U1111-1291-1101
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decreased Chest Mobility 329647 0
Weakness in Cough Strength 329648 0
Weakness in Muscle Strength 329650 0
Physical inactivity 329652 0
Poor Quality of Life 329654 0
Parkinsonism 329656 0
COVID-19 329658 0
Condition category
Condition code
Neurological 326565 326565 0 0
Parkinson's disease
Infection 326567 326567 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this research, the data of Parkinson's patients who have had and 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.
Intervention code [1] 325843 0
Not applicable
Comparator / control treatment
Parkinson's patients without COVID-19 will be assigned as a control group.
Control group
Active

Outcomes
Primary outcome [1] 334416 0
The status of quality of life will be evaluated using Parkinson’s Disease Questionnaire (PDQ-39) questionnaire.
Timepoint [1] 334416 0
at survey time
Secondary outcome [1] 420565 0
Cough Strength will be evaluated using a Peak Flow Meter
Timepoint [1] 420565 0
at survey time
Secondary outcome [2] 420566 0
Daily average step counts will be recorded via a pedometer. All individuals will be asked to carry their pedometers with them during the day and record to their diaries.
Timepoint [2] 420566 0
at survey time, everyday within 3 days after confirming enrolment
Secondary outcome [3] 420567 0
Hand grip strength will be evaluated using a hand dynamometer.
Timepoint [3] 420567 0
at survey time
Secondary outcome [4] 420570 0
Chest mobility will be evaluated using a tape measure.
Timepoint [4] 420570 0
at survey time
Secondary outcome [5] 420571 0

Cognitive state will be evaluated using The mini–mental state examination (MMSE)
Timepoint [5] 420571 0
at survey time

Eligibility
Key inclusion criteria
Inclusion criteria for Parkinson's patients with 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 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for Parkinson's patients with and without 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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size required for the study was calculated using the GPower (G*Power 3.0.10 system) program. In order to median difference (23.04) in the total quality of life score between the two groups by reaching 0.05 a value, 1.1 effect size and 80% strength, it was determined that at least 21 individuals should be included in the COVID-19 survivors group and at least 11 individuals should be included in control group.
At the end of the study, statistical analyzes will be made using the SPSS 15.0 program. By using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests), the conformity of all variables to normal distribution will be investigated. Descriptive analyzes will be given using numbers and percentage (%) for categorical variables, median and interquartile range (IQR) for non-normally distributed variables, mean and standard deviation (x±ss) for normally distributed variables. The Independent Sample t test (Student t test) will be used to compare the variables that fit the normal distribution, the Mann-Whitney U test will be used to compare the data that do not fit, and the Chi-square test will be used to compare the uncountable data. The probability of error in statistical analysis will be determined as p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 25385 0
Turkey
State/province [1] 25385 0
Izmir

Funding & Sponsors
Funding source category [1] 313631 0
Self funded/Unfunded
Name [1] 313631 0
none
Country [1] 313631 0
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country
Turkey
Secondary sponsor category [1] 315394 0
Individual
Name [1] 315394 0
Merve SAHIN
Address [1] 315394 0
Bandirma Health Practice and Research Hospital, Department of Neurology, Yeni Quarter, Sehit Astsubay Mustafa Soner Varlik street No:75, 10200 Bandirma/Balikesir
Country [1] 315394 0
Turkey
Secondary sponsor category [2] 315396 0
Individual
Name [2] 315396 0
Ozlem CINAR OZDEMIR
Address [2] 315396 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [2] 315396 0
Turkey
Secondary sponsor category [3] 315398 0
Individual
Name [3] 315398 0
Yasemin UNAL
Address [3] 315398 0
Bandirma Health Practice and Research Hospital, Department of Neurology, Yeni Quarter, Sehit Astsubay Mustafa Soner Varlik street No:75, 10200 Bandirma/Balikesir
Country [3] 315398 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312780 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 312780 0
Ethics committee country [1] 312780 0
Turkey
Date submitted for ethics approval [1] 312780 0
12/01/2023
Approval date [1] 312780 0
29/03/2023
Ethics approval number [1] 312780 0
2023/04-01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125890 0
A/Prof GÜLSAH BARGI
Address 125890 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125890 0
Turkey
Phone 125890 0
+905317938766
Fax 125890 0
+90 232 260 1004
Email 125890 0
[email protected]
Contact person for public queries
Name 125891 0
GÜLSAH BARGI
Address 125891 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125891 0
Turkey
Phone 125891 0
+905317938766
Fax 125891 0
+90 232 260 1004
Email 125891 0
[email protected]
Contact person for scientific queries
Name 125892 0
GÜLSAH BARGI
Address 125892 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125892 0
Turkey
Phone 125892 0
+905317938766
Fax 125892 0
+90 232 260 1004
Email 125892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I can not share the data of individuals included in the study in our country within the scope of the personal data protection law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.