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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05511402
Other study ID # 630
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 25, 2022
Est. completion date December 10, 2022

Study information

Verified date August 2022
Source Saglik Bilimleri Universitesi
Contact Fatih Soke, Asst. Prof.
Phone +90 506 932 81 02
Email fatih.soke@sbu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date December 10, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - at least 40years of age - diagnosed with Parkinson's Disease - Hoehn and Yahr stage of 1 and 3 Exclusion Criteria: - any other neurologic disorders, - any cardiovascular, orthopedic, vestibular or rheumatic conditions that impact exercise training - visual, auditory, and perception problems.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise training
People with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program.

Locations

Country Name City State
Turkey Saglik Bilimleri Universitesi Ankara

Sponsors (2)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Dani C, Proença 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. — View Citation

Dumitrescu 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. — View Citation

Elokda 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. — View Citation

Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S26-36; discussion S36-8. Review. — View Citation

Khan 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. Review. — View Citation

Martin 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. Review. — View Citation

Smeyne 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. Review. — View Citation

Xu 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. Review. — View Citation

Yuan 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 minutes
Primary 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. 10 minutes
Primary Glutathione Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species. 10 minutes
Primary Oxidative glutathione Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site. 10 minutes
Primary Zonulin The levels of zonulin can reflect systemic inflammation and oxidative stress. 10 minutes
Secondary 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. 15 minutes
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