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

August 22, 2022 updated by: Fatih Söke, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Saglik Bilimleri Universitesi
        • Contact:
        • Principal Investigator:
          • Ayse Bora Tokcaer, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aerobic exercise
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
People with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program.
ACTIVE_COMPARATOR: Conventional physiotherapy
This group will participate in a conventional physiotherapy program (8-week, 3 times weekly, and 45-min each time).
Other: Exercise training
People with Parkinson's Disease will be received a supervised physiotherapy and rehabilitation program.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Disorders Society Unified Parkinson's Disease Rating Scale
Time Frame: 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Collaborators

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 25, 2022

Primary Completion (ANTICIPATED)

November 30, 2022

Study Completion (ANTICIPATED)

December 10, 2022

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (ACTUAL)

August 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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