Clinical Trials Directory

Trials / Completed

CompletedNCT04379778

Aerobic Exercise and Brain Health in Parkinson's

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
40 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERAerobic exerciseProgressive moderate to high intensity aerobic exercise.

Timeline

Start date
2021-03-01
Primary completion
2023-10-01
Completion
2023-10-01
First posted
2020-05-07
Last updated
2024-05-08

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04379778. Inclusion in this directory is not an endorsement.