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Effect of Aerobic Training on Oxidative Stress Markers in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, exercise, total antioxidant status, total oxidant status, glutathione, oxidative glutathione, zonulin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saglik Bilimleri Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise

Conventional physiotherapy

Arm Description

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).

This group will participate in a conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time).

Outcomes

Primary Outcome Measures

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.
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.
Glutathione
Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species.
Oxidative glutathione
Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site.
Zonulin
The levels of zonulin can reflect systemic inflammation and oxidative stress.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2022
Last Updated
August 22, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05511402
Brief Title
Effect of Aerobic Training on Oxidative Stress Markers in Patients With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 25, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, exercise, total antioxidant status, total oxidant status, glutathione, oxidative glutathione, zonulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional physiotherapy
Arm Type
Active Comparator
Arm Description
This group will participate in a conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time).
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
People with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program.
Primary Outcome Measure Information:
Title
Total antioxidant status
Description
Total antioxidant status is an important marker of total antioxidant capacity and it indicates an overall measure for the cumulative action of all antioxidants.
Time Frame
10 minutes
Title
Total oxidant status
Description
Total oxidant status is an significant marker of total oxidant capacity and it indicates an overall measure for the cumulative action of all oxidants.
Time Frame
10 minutes
Title
Glutathione
Description
Glutathione is an important intracellular antioxidant that protects against a variety of different antioxidant species.
Time Frame
10 minutes
Title
Oxidative glutathione
Description
Oxidative glutathione generated by glutathione reductase should be provided as decreased glutathione to the site.
Time Frame
10 minutes
Title
Zonulin
Description
The levels of zonulin can reflect systemic inflammation and oxidative stress.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Movement Disorders Society Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Soke, Asst. Prof.
Phone
+90 506 932 81 02
Email
fatih.soke@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Bora Tokcaer, Prof. Dr.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglik Bilimleri Universitesi
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Soke, Asst. Prof.
Phone
+905069328102
Email
fatih.soke@sbu.edu.tr
First Name & Middle Initial & Last Name & Degree
Ayse Bora Tokcaer, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12666096
Citation
Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S26-36; discussion S36-8. doi: 10.1002/ana.10483.
Results Reference
background
PubMed Identifier
20461398
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.
Results Reference
background
PubMed Identifier
32394964
Citation
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.
Results Reference
background
PubMed Identifier
31607362
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.
Results Reference
background
PubMed Identifier
30886681
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.
Results Reference
background
PubMed Identifier
26010212
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.
Results Reference
background
PubMed Identifier
34220443
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.
Results Reference
background
PubMed Identifier
23665395
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.
Results Reference
background
PubMed Identifier
19542204
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.
Results Reference
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Effect of Aerobic Training on Oxidative Stress Markers in Patients With Parkinson's Disease

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