Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Mean Change in Cognitive Function
研究概览
简要总结
The overall objective of this study is to determine how high intensity endurance exercise affects both cognition and the signs and symptoms of Parkinson's disease as well as if certain brain structures and functions also change with this exercise.
详细描述
The overall purpose and objective of this project is to test the hypothesis that high intensity endurance exercise causes beneficial brain adaptation in patients with mild cognitive impairment in Parkinson's disease (PD-MCI). Aim 1 will determine the effect of high intensity endurance exercise on cognitive function and other clinical symptoms in PD-MCI. Aim 2 will determine the effect of high intensity endurance exercise on brain structure and function in PD-MCI. Aim 3 will determine the effect of high intensity endurance exercise on cortisol in PD-MCI. Aim 4 will determine the effect of high intensity endurance exercise on inflammation-related biomarkers found in blood in PD-MCI. Aim 5 will determine the effect of high intensity endurance exercise on peripheral levels of neurotrophic factors found in blood in PD-MCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ages 40-85
- •A diagnosis of idiopathic PD
- •A diagnosis of PD-MCI
- •Due to the stringent head motion during fMRI, we will only include a patient with a head tremor of <
- •Hoehn and Yahr stage < or equal to 3
- •Stable medication regimen for > or equal to 30 days before entering the study
- •Living with a carepartner
排除标准
- •PD subjects meeting MDS criteria for PD dementia or having a SCOPA-Cog score less than or equal to 16, or PD subjects having normal cognition defined as a SCOPA-Cog Score of is greater or equal to
- •Atypical or secondary parkinsonism as determined by referring Neurologist
- •Other disorders that might interfere with ability to perform high intensity endurance exercise (e.g. history of stroke, respiratory problems, traumatic brain injury, known advanced osteoarthritis, or neuromuscular disease).
- •Individuals with known injury, disease, or condition that would affect the ability to perform endurance exercise.
- •Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse that would, in the judgment of the investigator, interfere with the subject's ability to participate in the study.
- •"Vigorous athletes" participating in any exercise program 2X/week or more will be excluded.
- •Individuals with any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip (i.e., an ° Persons who have had a long history of working in metal shops will be excluded unless they have had a previous orbital x-ray scan clearing them for participation in MRI studies.
- •Females who are pregnant or might be pregnant will be excluded from participation.
- •Individuals who are claustrophobic and unable to tolerate a brain MRI scan will be excluded.
- •Treatment with cholinesterase inhibitors or memantine (i.e., medications approved for treatment of dementia) or medications affecting cognition (i.e., anticholinergics)
- •Use of medications that might interfere with neuromuscular junction function such as D-penicillamine and aminoglycoside antibiotics.
- •Use of medications that might interfere with the BOLD contrast or heart response to exercise (e.g. β blockers).
- •Individuals at high risk for cardiovascular disease as defined in Table 2.2 by the new ACSM guidelines.(Medicine 2014)
- •Younger than 40 and older than
- •We exclude participants younger than 40 because these young onset patients may not be typical of the majority of patients who get the disease later in life. We exclude participants older than 85 because of the limited evidence they can successfully complete a high-intensity endurance exercise program. We also exclude patients whose disease was diagnosed before the age of
- •Individuals with known endocrine abnormalities or steroid use that could affect cortisol levels (e.g., Cushing's syndrome, pituitary or adrenal gland disease or adrenalectomy, use of steroid-based medications.
- •Individuals with strong history of chronic inflammatory or autoimmune diseases or history of chronic use of NSAIDs, which could cause abnormal levels of inflammatory markers in the plasma.
- •We will exclude adults unable to consent, individuals who are not yet adults, pregnant women, prisoners and children from this study.
结局指标
主要结局
Mean Change in Cognitive Function
时间窗: Baseline and 6 Months
Mean change in cognitive function from baseline to 6-months as measured by global statistical test (GST) for cognitive domains. This will be a composite score reported as Z-scores. The Z-score indicates the number of standard deviations away from the mean, which is based on normative (healthy control) data. A Z-score of 0 is equal to the mean of the normative data with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-scores indicates a favorable outcome. The GSTs will be calculated from the following neuropsychological tests administered in the cognitive test battery reflecting specific cognitive domains: * Attention/Working Memory - Trail Making Test-Part A * Executive Function - Trail Making Test-Part B, Clock Draw, Raven's Progressive Matrices * Memory - Hopkin Verbal Learning Test-Revised, Free and Cued Selective Reminding Test, Figural Memory Test * Processing Speed - Symbol Digit Modality Test
次要结局
- 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Non Motor Experiences of Daily Living Score(Baseline and 6 Months)
- 6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale(Baseline and 6 Months)
- 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Motor Experiences of Daily Living)(Baseline and 6 Months)
- 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score(Baseline and 6 Months)
- 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score(Baseline and 6 Months)
- 6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS)(Baseline and 6 Months)
- 6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging(Baseline and 6 Months)
- 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score(Baseline and 6 Months)
- 6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI)(Baseline and 6 Months)
- 6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D)(Baseline and 6 Months)
- 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL)(Baseline and 6 Months)
- The Boston Naming Test(Baseline and 6 Months)
- Benton Judgement of Line Orientation Test(Baseline and 6 Months)
- Activities Specific Balance Confidence Scale(Baseline and 6 Months)
- 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39)(Baseline and 6 Months)
- Intersecting Pentagon Copying Test(Baseline and 6 Months)
- New Freezing of Gait Questionnaire(Baseline and 6 Months)
- 6 Month Change in Hippocampus Volumes on Structural MRI(Baseline and 6 Months)
- 6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma(Baseline and 6 Months)
- Verbal Fluency Test(Baseline and 6 Months)
- Mini Balance Evaluation Systems Test(Baseline and 6 Months)
- 6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI(Baseline and 6 Months)
- Timed Up and Go Test (TUG)(Baseline and 6 Months)
- Six Minute Walk Test(Baseline and 6 Months)
- 6 Month Change in Salivary Cortisol Levels(Baseline and 6 Months)
- 6 Month Change in Soluble Inflammatory Biomarkers in Plasma(Baseline and 6 Months)
研究者
Daniel Corcos
Professor of Physical Therapy and Human Movement Sciences
Northwestern University