Exercise Neuroprotection in Parkinson's Disease

NCT05854524 | Recruiting DMC

• 1 other identifier: UNLVPT PDex2023.01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the relationships of exercise on inflammation in the body of older adults and people with Parkinson's disease (PD). This is important research for older adults but is especially important for people with PD because neuroinflammation is the main pathological mechanism that is responsible for neuron cell death in this neurodegenerative disease. As PD is a progressive disease, halting or slowing the degeneration is an important research target. Halting or slowing the disease progress is known as neuroprotection. Exercise is an attractive therapeutic treatment for people with PD as it has a lot of multi-systemic benefits, but also there is a lot of evidence to suggest that it helps improve symptoms and slow the progression of the disease. Exercise has been theorized to decrease inflammation and, therefore, has a lot of promise as a neuroprotective agent in slowing or halting the degeneration in PD. Unfortunately, there is not a lot of research that has looked into the effect of exercise on the biological processes of inflammation. Thus, the purpose of this study is to investigate the biological evidence that underlies the positive effect of exercise in people with PD.

Conditions

Parkinson Disease

Keywords

Exercise; Inflammation; Physical activity; Neuroprotection

Outcome Measures

Primary Outcomes (4)

• Exercise and inflammatory milieu

  International Physical Activity Questionnaire (IPAQ) and blood serum levels of the following: interleukin-6 (IL-6), tumor necrosis factor alpha (TNF), interleukin-1β (IL-1β), interleukin-2 (IL-2), interleukin-10 (IL-10), c-reactive protein (CRP), RANTES, BDNF, VEGF, nerve growth factor (NGF), GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity

  Baseline measurement only

• Inflammatory milieu comparison to controls

  Blood serum levels of the following: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity

  Baseline measurement only

• Exercise dose and biomarkers

  Change in blood serum levels of the following for the two different exercise conditions: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity, deglycase (DJ-1) protein, nonenzymatic antioxidants (Glutathione, Vitamin A, Vitamin C, Vitamin E).

  30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one week.

• Biomarkers in Parkinson Disease

  Change in blood serum levels of the following for people with Parkinson's disease and older adults: IL-6, TNF, IL-1β, IL-2, IL-10, CRP, RANTES, BDNF, VEGF, NGF, GDNF, Superoxide dismutase, catalase, glutathione peroxidase, total antioxidant capacity, DJ-1 protein, nonenzymatic antioxidants (Glutathione, Vitamin A, Vitamin C, Vitamin E).

  30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one week

Study Arms (2)

Parkinson Disease

ACTIVE COMPARATOR

Participants diagnosed with Parkinson disease (PD) will the main arm of the study and will be compared to the control group.

Procedure: Aerobic exercise

Control

ACTIVE COMPARATOR

Older, adults who are age- and sex-matched to the PD participants.

Procedure: Aerobic exercise

Interventions

Aerobic exercise PROCEDURE

The intervention is exercise and there are no drugs or devices used in this trial. The exercise consists of two intensity levels of a 30-minute aerobic exercise intervention with both arms crossing over to both conditions: low intensity exercise (60-70% of estimated maximum heart rate (EMRH)) and moderate-vigorous intensity exercise (75-85% of EMHR).

Control; Parkinson Disease

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Neurologist-diagnosed PD
• Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.
• years old
• No major medical diagnoses
• Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.

You may not qualify if:

• Diagnoses, identified by self-report, that would preclude exercise participation (e.g., heart arrhythmias, uncontrolled blood pressure, exercise-induced asthma).
• Those not deemed ready for exercise participation. Participants will be screened for exercise participation using the Physical Activities Readiness Questionnaire + which is used as a screening tool for all ages to identify risk factors that would clear someone for participation in moderate physical exercise.
• Those with dementia will be excluded because there are self-report questionnaires in this study. This will be identified using the Montreal Cognitive Assessment and a score at or below a 21. Participants with mild cognitive impairment and no impairment will be included.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV

Las Vegas, Nevada, 89154, United States

RECRUITING

Related Publications (9)

• Chao Y, Wong SC, Tan EK. Evidence of inflammatory system involvement in Parkinson's disease. Biomed Res Int. 2014;2014:308654. doi: 10.1155/2014/308654. Epub 2014 Jun 24.

  PMID: 25050341 BACKGROUND

• Kim R, Kim HJ, Kim A, Jang M, Kim A, Kim Y, Yoo D, Im JH, Choi JH, Jeon B. Peripheral blood inflammatory markers in early Parkinson's disease. J Clin Neurosci. 2018 Dec;58:30-33. doi: 10.1016/j.jocn.2018.10.079. Epub 2018 Oct 24.

  PMID: 30454693 BACKGROUND

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 BACKGROUND

• Zhang M, Li F, Wang D, Ba X, Liu Z. Exercise sustains motor function in Parkinson's disease: Evidence from 109 randomized controlled trials on over 4,600 patients. Front Aging Neurosci. 2023 Feb 14;15:1071803. doi: 10.3389/fnagi.2023.1071803. eCollection 2023.

  PMID: 36865410 BACKGROUND

• Fang X, Han D, Cheng Q, Zhang P, Zhao C, Min J, Wang F. Association of Levels of Physical Activity With Risk of Parkinson Disease: A Systematic Review and Meta-analysis. JAMA Netw Open. 2018 Sep 7;1(5):e182421. doi: 10.1001/jamanetworkopen.2018.2421.

  PMID: 30646166 BACKGROUND

• Xu Q, Park Y, Huang X, Hollenbeck A, Blair A, Schatzkin A, Chen H. Physical activities and future risk of Parkinson disease. Neurology. 2010 Jul 27;75(4):341-8. doi: 10.1212/WNL.0b013e3181ea1597.

  PMID: 20660864 BACKGROUND

• Palasz E, Wysocka A, Gasiorowska A, Chalimoniuk M, Niewiadomski W, Niewiadomska G. BDNF as a Promising Therapeutic Agent in Parkinson's Disease. Int J Mol Sci. 2020 Feb 10;21(3):1170. doi: 10.3390/ijms21031170.

  PMID: 32050617 BACKGROUND

• da Silva PG, Domingues DD, de Carvalho LA, Allodi S, Correa CL. Neurotrophic factors in Parkinson's disease are regulated by exercise: Evidence-based practice. J Neurol Sci. 2016 Apr 15;363:5-15. doi: 10.1016/j.jns.2016.02.017. Epub 2016 Feb 10.

  PMID: 27000212 BACKGROUND

• Zoladz JA, Majerczak J, Zeligowska E, Mencel J, Jaskolski A, Jaskolska A, Marusiak J. Moderate-intensity interval training increases serum brain-derived neurotrophic factor level and decreases inflammation in Parkinson's disease patients. J Physiol Pharmacol. 2014 Jun;65(3):441-8.

  PMID: 24930517 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Merrill Landers, DPT, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merrill Landers, DPT, PhD

CONTACT

17028951377; merrill.landers@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcomes assessors will be blinded to the main purpose and aims of the study. Additionally, both conditions are aerobic exercise conditions of different intensities so they will clearly know that they are exercising but will not know the main purpose behind the two different intensities.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: This is a cross-over design with two arms (Parkinson Disease and healthy control) and two conditions (low and high intensity aerobic exercise). The interventions for this Phase II trial are two different intensities of aerobic exercise.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 11, 2023
• Study Start: August 29, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)