Parkinson Disease
Conditions
Brief 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.
Interventions
OTHERAerobic exercise
Progressive moderate to high intensity aerobic exercise.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R2* MRI change | 0, 24 and 48 weeks | Effective transverse relaxation rate (R2\*) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| QSM MRI 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 |
| Timed up and go (TUG) change | 0, 24 and 48 weeks |
Countries
Denmark
Outcome results
None listed