Exercise and Parkinson's Disease: The Basis for Motor and Cognitive Benefits
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Dopamine release measured by RAC PET
研究概览
简要总结
The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported, however the mechanisms are unknown. The purpose of this study is to investigate the potential mechanisms of exercise in the brain for the treatment of PD.
详细描述
Positron Emission Tomography will be used to measure dopamine neuron density, endogenous dopamine release and neuroimflammation. We will also use functional magnetic resonance imaging (fMRI) to measure brain activity. Assessments will be conducted before and after a 12-week exercise intervention and 3-year follow-up. Participants will be randomly allocated into either an aerobic or a stretching intervention. Clinical measures of motor function, cognition and mood will also be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's Disease, Exercise less than 3x per week.
排除标准
- •. Describe which potential participants will be excluded from participation, and list the criteria for their exclusion.
- •atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
- •significant osteoporosis or arthritis;
- •other neurological disease/complications (e.g. myopathy, stroke, brain lesion, MS);
- •self-reports claustrophobia;
- •history of cancer within 5 years of study participation;
- •high dose of radiation from other procedures within the year;
- •not able to tolerate being off PD medication for up to 24 hours;
- •a female subject who is breast-feeding or pregnant.
- •Subjects who regularly use anti-inflammatories (only excluded for PBR scans).
- •Exclusion criteria for MRI scanning and magnetic stimulation from repetitive Transcranial Magnetic Stimulation (rTMS) scanning includes:
- •artificial heart valve;
- •brain aneurysm clip;
- •electrical stimulator for nerves or bones;
- •ear or eye implant;
- •implanted drug infusion pump;
- •coil, catheter, or filter in any blood vessel;
- •orthopedic hardware (artificial joint, plate, screws);
- •other metallic prostheses;
- •shrapnel, bullets, or other metal fragments;
- •surgery or tattoos (including tattooed eyeliner) in the last six weeks;
- •brain surgery
- •have a cardiac pacemaker, wires or defibrillator;
- •have had an injury where a piece of metal lodged in the eye or orbit;
- •have a ferromagnetic aneurysm clip; and
- •have a history of seizures/epilepsy
- •history of severe or uncontrolled headaches/migraines
- •taking medications that lower seizure threshold (e.g. amitryptiline, haloperidol)
- •Subjects may be excluded following study enrollment if they meet any of the following exclusion criteria:
- •significant cognitive impairment or depression;
- •significant or unstable cardiovascular or respiratory disease - all subjects will undergo a screening exercise bicycle stress test; or
- •failure to comply with the exercise or stretching intervention program by not completing at least 30 of the 36 exercise classes.
- •Severe/multiple head trauma(s)
结局指标
主要结局
Change in Dopamine release measured by RAC PET
时间窗: 4 months
次要结局
未报告次要终点
研究者
A. Jon Stoessl
Director of Clinical PET
Pacific Parkinson's Research Centre