NCT05511402

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 19, 2022

Last Update Submit

August 22, 2022

Conditions

Parkinson Disease

Keywords

Parkinson Diseaseexercisetotal antioxidant statustotal oxidant statusglutathioneoxidative glutathionezonulin

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Glutathione

    Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species.

    10 minutes

  • Oxidative glutathione

    Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site.

    10 minutes

  • Zonulin

    The levels of zonulin can reflect systemic inflammation and oxidative stress.

    10 minutes

Secondary Outcomes (1)

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale

    15 minutes

Study Arms (2)

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).

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).

Other: Exercise training

Interventions

Exercise trainingOTHER

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

Aerobic exerciseConventional physiotherapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 40years of age
  • diagnosed with Parkinson's Disease
  • Hoehn and Yahr stage of 1 and 3

You may not qualify if:

  • any other neurologic disorders,
  • any cardiovascular, orthopedic, vestibular or rheumatic conditions that impact exercise training
  • visual, auditory, and perception problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Ankara, Turkey (Türkiye)

Location

Related Publications (9)

  • Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S26-36; discussion S36-8. doi: 10.1002/ana.10483.

    PMID: 12666096BACKGROUND

  • 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.

    PMID: 20461398BACKGROUND

  • Dani 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.

    PMID: 32394964BACKGROUND

  • 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.

    PMID: 31607362BACKGROUND

  • 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.

    PMID: 30886681BACKGROUND

  • 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.

    PMID: 26010212BACKGROUND

  • 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.

    PMID: 34220443BACKGROUND

  • 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.

    PMID: 23665395BACKGROUND

  • 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.

    PMID: 19542204BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayse Bora Tokcaer, Prof. Dr.

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatih Soke, Asst. Prof.

CONTACT

+90 506 932 81 02fatih.soke@sbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 23, 2022

Study Start

August 25, 2022

Primary Completion

November 30, 2022

Study Completion

December 10, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)