Effects of Aerobic Exercise on Brain Health in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- R2* MRI change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
R2* MRI change
时间窗: 0, 24 and 48 weeks
Effective transverse relaxation rate (R2\*)
次要结局
- 6 min walk test (6MWT) change(0, 24 and 48 weeks)
- Neuromelanin MRI change(0, 24 and 48 weeks)
- Change in Levodopa equivalents(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)
- MDS-UPDRS change(0, 24 and 48 weeks)
- Aerobic capacity (VO2max test)(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)
- QSM MRI change(0, 24 and 48 weeks)
- DKI MRI change(0, 24 and 48 weeks)
- Timed up and go (TUG) change(0, 24 and 48 weeks)
- Depression (Beck Depression Inventory-II (BDI-II)) change(0, 24 and 48 weeks)
- Health-related quality of life (Parkinson's Disease Questionnaire (PDQ-39)) change(0, 24 and 48 weeks)
- Non-motor symptoms (Non-Motor Symptoms Questionnaire (NMSQ)) change(0, 24 and 48 weeks)