Aerobic Exercise and Brain Health in Parkinson's

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379778
• Other study ID #: Brain Health in Parkinson's
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Aerobic exercise
Progressive moderate to high intensity aerobic exercise.

Locations

Country	Name	City	State
Denmark	Sport Science, Department of Public Health, Aarhus University	Aarhus	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R2* MRI change	Effective transverse relaxation rate (R2*)	0, 24 and 48 weeks
Secondary	QSM MRI change		0, 24 and 48 weeks
Secondary	DKI MRI change		0, 24 and 48 weeks
Secondary	Neuromelanin MRI change		0, 24 and 48 weeks
Secondary	Volumetry MRI change		0, 24 and 48 weeks
Secondary	Change in blood markers (e.g. a-synuclein)		0, 24 and 48 weeks
Secondary	Change in Levodopa equivalents		0, 24 and 48 weeks
Secondary	MDS-UPDRS change		0, 24 and 48 weeks
Secondary	Aerobic capacity (VO2max test)		0, 24 and 48 weeks
Secondary	Timed up and go (TUG) change		0, 24 and 48 weeks
Secondary	6 min walk test (6MWT) change		0, 24 and 48 weeks
Secondary	Balance (Mini BESTest) change		0, 24 and 48 weeks
Secondary	Cognition (The Montreal Cognitive Assessment (MoCA)) change		0, 24 and 48 weeks
Secondary	Health-related quality of life (Parkinson's Disease Questionnaire (PDQ-39)) change		0, 24 and 48 weeks
Secondary	Depression (Beck Depression Inventory-II (BDI-II)) change		0, 24 and 48 weeks
Secondary	Non-motor symptoms (Non-Motor Symptoms Questionnaire (NMSQ)) change		0, 24 and 48 weeks