Aerobic Exercise and Brain Health in Parkinson's

Effects of Aerobic Exercise on Brain Health in Parkinson's Disease

The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness.

The study will be a single blinded randomized controlled trial with a 6-month long intervention.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Aerobic exercise

Detailed Description

Background: No approved medical treatments preventing, delaying or stopping Parkinson's disease (PD) exist, making identification of interventions having this potential a major priority. Exercise studies have demonstrated beneficial effects of aerobic exercise (AE) on aerobic capacity, cognition, depression and the Unified Parkinson's Disease Rating Scale (UPDRS). Animal studies show that AE can reduce α-synuclein aggregation and toxin-induced lesions in the nigrostriatal pathway while improving motor and cognitive function. Consequently, AE possesses neuroprotective potentials and thus represents a potentially inexpensive and easily accessible disease modifying therapy in PD. Evolving magnetic resonance imaging (MRI) techniques offer valid and reliable biomarkers to monitor disease progression, but no longitudinal MRI study has assessed the neuroprotective potentials of AE in PD.

Aim: To investigate whether 24 weeks of AE can delay PD progression markers and improve motor/non-motor symptoms in PD.

Methods: 70 PD patients will be randomized 1:1 to 24 weeks of supervised AE (60 sessions, moderate to high intensity) or standard care. Neuroprotective effects will be determined by MRI scans (R2*, quantitative susceptibility mapping, diffusion kurtosis imaging, neuromelanin-weighted MRI, volumetry), blood markers and Levodopa equivalents. Clinical (MDS-UPDRS III) and subjective (MDS-UPDRS I) outcomes are also assessed.

Perspectives: By combining expertise from exercise physiology, radiology, endocrinology and neuropsychology a novel approach is taken aiming to understand the possible neuroprotective effects of AE in PD. This would be of high relevance to PD patients and their relatives. From a societal perspective it may lower disability-related costs by optimizing PD rehabilitation. In case of positive findings, this would provide the first convincing human evidence of a disease modifying effect of AE in PD potentially changing clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C
    • Aarhus, Aarhus C, Denmark, 8000
      • Sport Science, Department of Public Health, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent
• Age ≥ 40 years
• Idiopathic PD diagnosis (within the previous five years)
• Patients in symptomatic therapy / not in therapy. Patients who are not already taking medication are not expected to need medication within 6 months of inclusion (in case of drug startup, this is noted)
• Hoehn & Yahr ≤ 3
• Ability to transport oneself to and from exercise and testing

Exclusion Criteria:

• Alcohol abuse, depression, pacemaker
• Comorbidity/competing (neurological) disorder preventing participation in the intervention
• Pregnancy
• Metallic implants that prevent MRI.
• Expected exercise adherence below 85% of all planned sessions.
• Systematic moderate-high-level AE more than twice per week prior to start-up in the project

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise; Moderate to high intensity aerobic exercise for 24 weeks.	Other: Aerobic exercise; Progressive moderate to high intensity aerobic exercise.
No Intervention: Standard care; Habitual lifestyle including standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R2* MRI change	Effective transverse relaxation rate (R2*)	0, 24 and 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
QSM MRI change	0, 24 and 48 weeks
DKI MRI change	0, 24 and 48 weeks
Neuromelanin MRI change	0, 24 and 48 weeks
Volumetry MRI change	0, 24 and 48 weeks
Change in blood markers (e.g. α-synuclein)	0, 24 and 48 weeks
Change in Levodopa equivalents	0, 24 and 48 weeks
MDS-UPDRS change	0, 24 and 48 weeks
Aerobic capacity (VO2max test)	0, 24 and 48 weeks
Timed up and go (TUG) change	0, 24 and 48 weeks
6 min walk test (6MWT) change	0, 24 and 48 weeks
Balance (Mini BESTest) change	0, 24 and 48 weeks
Cognition (The Montreal Cognitive Assessment (MoCA)) change	0, 24 and 48 weeks
Health-related quality of life (Parkinson's Disease Questionnaire (PDQ-39)) change	0, 24 and 48 weeks
Depression (Beck Depression Inventory-II (BDI-II)) change	0, 24 and 48 weeks
Non-motor symptoms (Non-Motor Symptoms Questionnaire (NMSQ)) change	0, 24 and 48 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Martin Langeskov-Christensen, Ph.d., University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): April 25, 2024

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Brain Health in Parkinson's

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