The ParkCycle Study: Effects of Aerobic Exercise on Cognitive and Adaptive Plasticity in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Trails A and B task
研究概览
简要总结
The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.
详细描述
Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. The promising animal results have not been translated to patients with PD so far. This is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease according to the UK Queen Square Brain Bank Criteria
- •Hoehn & Yahr disease stages I-II
- •Age between 30 and 75 years
- •Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition
- •Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations.
排除标准
- •Unclear diagnosis with Red Flags
- •Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score < 24
- •Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner
- •Pulmonary diseases; known by specialist or medical practitioner
- •High risk of cardiovascular complications:
- •Hypertension (systole >150 and diastole > 100)
- •Diabetes Mellitus; known by specialist or medical practitioner
- •Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner
- •Cardiac rhythm disorder; known by specialist or medical practitioner
- •Heart failure; known by specialist or medical practitioner
- •Use of ß-blockers
- •Not able to complete American (for Cleveland site) or Dutch questionnaires (for the Nijmegen site)
- •Daily institutionalized care
- •Contra-indications for fMRI:
- •Pregnancy
- •Metallic implants or electronic devices
- •Previous seizure
- •Claustrophobia
- •Not able to keep the head still for longer period, i.e. due to severe head tremor
结局指标
主要结局
Trails A and B task
时间窗: every month for 6-7 months
this test requires subjects to connect numbers on a screen from 1 to 25 (part A) and to connect numbers to letters. This neuropsychological test has already been proven to be sensitive to frontal lobe damage (e.g. Boll 1981) and has been recognised as an outcome for executive function in PD21. This test is performed using an online system called i-COMET that allows subject to complete the task weekly at home. Subjects have to login at the i-COMET website (https://i-comet.com) with a username and password that is provided to them by the research team.
次要结局
- UPDRS(baseline and after 6 months follow-up (FU))
- Cognitive tests(baseline and after 6 months FU)
- Kinetics tests(baseline and after 6 months FU)
- questionaires(baseline and after 6 months FU)
- maximal exercise test(baseline and after 6 months FU)
- feasibility parameters(after 6 months (termination of intervention))
- neuroplasticity(baseline and after 6 months FU)