COVID-19 Respiratory InfectionNCT06008444
Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19
An observational study of COVID-19 Respiratory Infection and Parkinson Disease, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection, Parkinson Disease
- What is being tested?
- Physical Evaluations of post-COVID-19 individuals and Physical Evaluations of non-post-COVID-19 individuals
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2023to 30 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19
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.
Read the 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.
- Conditions
- COVID-19 Respiratory Infection, Parkinson Disease
- Being tested
- Physical Evaluations of post-COVID-19 individuals, Physical Evaluations of non-post-COVID-19 individuals
- Keywords
- pain, chest mobility, cough, muscle strength, physical activity, quality of life
- Medical subject headings
- Parkinson Disease, Pain, Cough, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations of post-COVID-19 individualsOther
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 individualsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID-19 group | This group will consist of individuals with Parkinson disease who have had COVID-19. Receives: Other: Physical Evaluations of post-COVID-19 individuals | |
| Control group | The control group will consist of individuals with Parkinson disease without post-COVID-19. Receives: Other: Physical Evaluations of non-post-COVID-19 individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Cough Strength
Cough Strength will be evaluated using a Peak Flow Meter.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Hand grip strength
Hand grip strength will be evaluated using a hand dynamometer.
Measured: through study completion, an average of 1 year
Chest mobility
Chest mobility will be evaluated using a tape measure.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start13 May 2023
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Study director, Izmir Democracy UniversityMERVE ŞAHİN, Principal investigator, Izmir Democracy UniversityÖZLEM ÇİNAR ÖZDEMİR, Principal investigator, Izmir Democracy UniversityYASEMİN ÜNAL, Principal investigator, Bandirma Health Practice and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008444
- Sponsor's protocol ID
- Effects of COVID on Parkinson
- Status last verified
- May 2025
- First submitted
- 21 Aug 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36045133Shalash 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.
PubMed 32428342
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19
- ClinicalTrials.gov ID
- NCT06008444
- Acronym / sponsor ID
- Effects of COVID on Parkinson
- Conditions
- COVID-19 Respiratory Infection, Parkinson Disease
- Keywords
- pain, chest mobility, cough, muscle strength, physical activity, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 group | – | Other: Physical Evaluations of post-COVID-19 individualsThis group will consist of individuals with Parkinson disease who have had COVID-19. |
| Control group | – | Other: Physical Evaluations of non-post-COVID-19 individualsThe control group will consist of individuals with Parkinson disease without post-COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Evaluations of post-COVID-19 individualsIn 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. | Other | Post-COVID-19 group |
| Physical Evaluations of non-post-COVID-19 individualsIn 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. | Other | Control group |
Primary outcome
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.
5 secondary outcomes
Cough Strength
Time frame: through study completion, an average of 1 year
Daily average step count
Time frame: through study completion, an average of 1 year
Hand grip strength
Time frame: through study completion, an average of 1 year
Chest mobility
Time frame: through study completion, an average of 1 year
Cognitive status
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 36045133Shalash 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.
- Background: PubMed 32428342Shalash 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜLŞAH BARĞI study director
Izmir Democracy University
MERVE ŞAHİN principal investigator
Izmir Democracy University
ÖZLEM ÇİNAR ÖZDEMİR principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection and Parkinson Disease, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06008444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.