Aerobic Exercise and Brain Health in Parkinson's

May 7, 2024 updated by: University of Aarhus

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

Completed

Conditions

Intervention / Treatment

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

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

Study Locations

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

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 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

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 Assignment
  • Masking: Single

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
Time Frame: 0, 24 and 48 weeks
Effective transverse relaxation rate (R2*)
0, 24 and 48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

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

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 (Actual)

March 1, 2021

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

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)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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