Parkinson DiseaseNCT05511402
Effect of Aerobic Training on Oxidative Stress Markers in Patients With Parkinson's Disease
A study testing Exercise training in people with Parkinson Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is a chronic, neurodegenerative disorder characterized with the loss of dopamine-producing neurons. This loss is likely to be related with several environmental and genetic factors. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 10 Dec 2022
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 40years of age
- diagnosed with Parkinson's Disease
- Hoehn and Yahr stage of 1 and 3
Who cannot join
- any other neurologic disorders,
- any cardiovascular, orthopedic, vestibular or rheumatic conditions that impact exercise training
- visual, auditory, and perception problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi
Ankara
Fatih Soke, Asst. Prof., +905069328102, fatih.soke@sbu.edu.tr
Ayse Bora Tokcaer, Prof. Dr.
About this study
Official title: The Effect of Aerobic Training on Total Antioxidant Status, Total Oxidant Status, Glutathione, Oxidative Glutathione and Zonulin Levels in Patients With Parkinson's Disease
Parkinson's disease is a chronic, neurodegenerative disorder characterized with the loss of dopamine-producing neurons. This loss is likely to be related with several environmental and genetic factors. One of the most important factor that is responsible for the initation and progression of the disease is oxidative stress. Exercise training, especially aerobic training, can change the levels of oxidative markers because exercise can lead to decrease oxidative stress in patients with Parkinson's disease. Therefore, this study aims to investigate (1) the effect of aerobic training on total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels, (2) the relationship between the change of motor symptoms and disease severity and the change of total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels.
- Conditions
- Parkinson Disease
- Being tested
- Exercise training
- Keywords
- Parkinson Disease, exercise, total antioxidant status, total oxidant status, glutathione, oxidative glutathione, zonulin
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
People with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | This group will participate in an aerobic training program (8-week, 3 times weekly, and 30-min each time) and conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time). Receives: Other: Exercise training |
| Conventional physiotherapy | Active comparator | This group will participate in a conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time). Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antioxidant status
Total antioxidant status is an important marker of total antioxidant capacity and it indicates an overall measure for the cumulative action of all antioxidants.
Measured: 10 minutes
Total oxidant status
Total oxidant status is an significant marker of total oxidant capacity and it indicates an overall measure for the cumulative action of all oxidants.
Measured: 10 minutes
Glutathione
Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species.
Measured: 10 minutes
Oxidative glutathione
Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site.
Measured: 10 minutes
Zonulin
The levels of zonulin can reflect systemic inflammation and oxidative stress.
Measured: 10 minutes
Secondary outcomes (1)
Movement Disorders Society Unified Parkinson's Disease Rating Scale
The Movement Disorders Society Unified Parkinson's Disease Rating Scale is the most commonly used scale to assess disease severity in Parkinson's Disease. It consists of four parts: (1) non-motor experiences of daily living, (2) motor experiences of daily living, (3) motor examination, and (4) motor complications.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start25 Aug 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Fatih Söke, Saglik Bilimleri Universitesi
- Investigators
- Ayse Bora Tokcaer, Prof. Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511402
- Sponsor's protocol ID
- 630
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S26-36; discussion S36-8. doi: 10.1002/ana.10483.
PubMed 12666096Elokda A, DiFrancisco-Donoghue J, Lamberg EM, Werner WG. Effects of exercise induced oxidative stress on glutathione levels in Parkinson's disease on and off medication. J Neurol. 2010 Oct;257(10):1648-53. doi: 10.1007/s00415-010-5584-6. Epub 2010 May 12.
PubMed 20461398Dani C, Proenca IT, Marinho J, Peccin P, da Silva IRV, Nique S, Striebel V, Pochmann D, Elsner VR. Aquatic exercise program-modulated oxidative stress markers in patients with Parkinson's disease. Neural Regen Res. 2020 Nov;15(11):2067-2072. doi: 10.4103/1673-5374.276337.
PubMed 32394964Xu X, Fu Z, Le W. Exercise and Parkinson's disease. Int Rev Neurobiol. 2019;147:45-74. doi: 10.1016/bs.irn.2019.06.003. Epub 2019 Jun 20.
PubMed 31607362Khan Z, Ali SA. Oxidative stress-related biomarkers in Parkinson's disease: A systematic review and meta-analysis. Iran J Neurol. 2018 Jul 6;17(3):137-144.
PubMed 30886681Yuan Y, Tong Q, Zhang L, Jiang S, Zhou H, Zhang R, Zhang S, Xu Q, Li D, Zhou X, Ding J, Zhang K. Plasma antioxidant status and motor features in de novo Chinese Parkinson's disease patients. Int J Neurosci. 2016;126(7):641-6. doi: 10.3109/00207454.2015.1054031. Epub 2015 Jul 14.
PubMed 26010212Dumitrescu L, Marta D, Danau A, Lefter A, Tulba D, Cozma L, Manole E, Gherghiceanu M, Ceafalan LC, Popescu BO. Serum and Fecal Markers of Intestinal Inflammation and Intestinal Barrier Permeability Are Elevated in Parkinson's Disease. Front Neurosci. 2021 Jun 18;15:689723. doi: 10.3389/fnins.2021.689723. eCollection 2021.
PubMed 34220443Smeyne M, Smeyne RJ. Glutathione metabolism and Parkinson's disease. Free Radic Biol Med. 2013 Sep;62:13-25. doi: 10.1016/j.freeradbiomed.2013.05.001. Epub 2013 May 8.
PubMed 23665395Martin HL, Teismann P. Glutathione--a review on its role and significance in Parkinson's disease. FASEB J. 2009 Oct;23(10):3263-72. doi: 10.1096/fj.08-125443. Epub 2009 Jun 19.
PubMed 19542204
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Training on Total Antioxidant Status, Total Oxidant Status, Glutathione, Oxidative Glutathione and Zonulin Levels in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05511402
- Acronym / sponsor ID
- 630
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, exercise, total antioxidant status, total oxidant status, glutathione, oxidative glutathione, zonulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 25 Aug 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 23 Aug 2022 (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.
Parkinson's disease is a chronic, neurodegenerative disorder characterized with the loss of dopamine-producing neurons. This loss is likely to be related with several environmental and genetic factors. One of the most important factor that is responsible for the initation and progression of the disease is oxidative stress. Exercise training, especially aerobic training, can change the levels of oxidative markers because exercise can lead to decrease oxidative stress in patients with Parkinson's disease. Therefore, this study aims to investigate (1) the effect of aerobic training on total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels, (2) the relationship between the change of motor symptoms and disease severity and the change of total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Exercise trainingThis group will participate in an aerobic training program (8-week, 3 times weekly, and 30-min each time) and conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time). |
| Conventional physiotherapy | Active comparator | Other: Exercise trainingThis group will participate in a conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 40years of age
- diagnosed with Parkinson's Disease
- Hoehn and Yahr stage of 1 and 3
Key exclusion criteria (3 listed)
- any other neurologic disorders,
- any cardiovascular, orthopedic, vestibular or rheumatic conditions that impact exercise training
- visual, auditory, and perception problems.
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 |
|---|---|---|
| Exercise trainingPeople with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program. | Other | Aerobic exercise, Conventional physiotherapy |
Primary outcome
Total antioxidant status
Time frame: 10 minutes
Total antioxidant status is an important marker of total antioxidant capacity and it indicates an overall measure for the cumulative action of all antioxidants.
Total oxidant status
Time frame: 10 minutes
Total oxidant status is an significant marker of total oxidant capacity and it indicates an overall measure for the cumulative action of all oxidants.
Glutathione
Time frame: 10 minutes
Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species.
Oxidative glutathione
Time frame: 10 minutes
Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site.
Zonulin
Time frame: 10 minutes
The levels of zonulin can reflect systemic inflammation and oxidative stress.
1 secondary outcome
Movement Disorders Society Unified Parkinson's Disease Rating Scale
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 12666096Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S26-36; discussion S36-8. doi: 10.1002/ana.10483.
- Background: PubMed 20461398Elokda A, DiFrancisco-Donoghue J, Lamberg EM, Werner WG. Effects of exercise induced oxidative stress on glutathione levels in Parkinson's disease on and off medication. J Neurol. 2010 Oct;257(10):1648-53. doi: 10.1007/s00415-010-5584-6. Epub 2010 May 12.
- Background: PubMed 32394964Dani C, Proenca IT, Marinho J, Peccin P, da Silva IRV, Nique S, Striebel V, Pochmann D, Elsner VR. Aquatic exercise program-modulated oxidative stress markers in patients with Parkinson's disease. Neural Regen Res. 2020 Nov;15(11):2067-2072. doi: 10.4103/1673-5374.276337.
- Background: PubMed 31607362Xu X, Fu Z, Le W. Exercise and Parkinson's disease. Int Rev Neurobiol. 2019;147:45-74. doi: 10.1016/bs.irn.2019.06.003. Epub 2019 Jun 20.
- Background: PubMed 30886681Khan Z, Ali SA. Oxidative stress-related biomarkers in Parkinson's disease: A systematic review and meta-analysis. Iran J Neurol. 2018 Jul 6;17(3):137-144.
- Background: PubMed 26010212Yuan Y, Tong Q, Zhang L, Jiang S, Zhou H, Zhang R, Zhang S, Xu Q, Li D, Zhou X, Ding J, Zhang K. Plasma antioxidant status and motor features in de novo Chinese Parkinson's disease patients. Int J Neurosci. 2016;126(7):641-6. doi: 10.3109/00207454.2015.1054031. Epub 2015 Jul 14.
- Background: PubMed 34220443Dumitrescu L, Marta D, Danau A, Lefter A, Tulba D, Cozma L, Manole E, Gherghiceanu M, Ceafalan LC, Popescu BO. Serum and Fecal Markers of Intestinal Inflammation and Intestinal Barrier Permeability Are Elevated in Parkinson's Disease. Front Neurosci. 2021 Jun 18;15:689723. doi: 10.3389/fnins.2021.689723. eCollection 2021.
- Background: PubMed 23665395Smeyne M, Smeyne RJ. Glutathione metabolism and Parkinson's disease. Free Radic Biol Med. 2013 Sep;62:13-25. doi: 10.1016/j.freeradbiomed.2013.05.001. Epub 2013 May 8.
- Background: PubMed 19542204Martin HL, Teismann P. Glutathione--a review on its role and significance in Parkinson's disease. FASEB J. 2009 Oct;23(10):3263-72. doi: 10.1096/fj.08-125443. Epub 2009 Jun 19.
- 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.
Ayse Bora Tokcaer, Prof. Dr. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Parkinson Disease, run by Saglik Bilimleri Universitesi 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatih Soke, Asst. Prof. (+90 506 932 81 02, fatih.soke@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total antioxidant status (time frame: 10 minutes). The study lists 5 primary outcomes in all. 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 NCT05511402, which also lists 9 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 25 Aug 2022.