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

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511402

Collaborator

Gazi University (Other)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Exercise training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 25, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 10, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Movement Disorders Society Unified Parkinson's Disease Rating Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.