Exercise Targeting Cognitive Impairment in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Context Dependent Motor Learning (CDML)
研究概览
简要总结
The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
详细描述
Mild cognitive impairment (MCI), particularly of the executive function (EF) subtype, is common in Parkinson's disease (PD) and transitions to dementia, increased fall risk, and poor quality of life. EF is a set of processes that include mental flexibility and attention that are needed to learn and optimize performance of complex cognitive and motor skills. Such skills include the ability to generalize task performance under different conditions (context processing) and to perform two tasks simultaneously termed dual-task (DT) performance. Deficits in EF lead to problems in daily functioning and loss of independence and create psychosocial and economic burdens on patients and caregivers and stakeholders including health care providers. There is currently no effective treatment in PD to address EF deficits. Our animal and clinical studies in PD demonstrate that skilled exercise facilitates neuroplasticity of the basal ganglia (BG), a brain region sub-serving EF and supports the hypothesis that exercise will reverse EF deficits in PD. Furthermore, recent studies in healthy aging support that skill-based exercise that specifically promotes motor skill fitness (MSF), compared with aerobic exercise that promotes cardiovascular fitness (CF), has a greater impact on EF and related BG circuits. The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on MCI of the EF subtype in PD; we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing and able to provide informed consent
- •confirmed diagnosis of idiopathic PD based on the United Kingdom Brain Bank criteria
- •Mild cognitive impairment (Level II criteria Movement Disorder Task Force)
- •medically eligible for MRI imaging
- •able to provide a written medical clearance from their primary physician to participate in exercise
- •stable PD medications for 3 months
排除标准
- •a Hoehn & Yahr staging greater than 2.5 at screening
- •severe cardiac disease (New York Heart Association classification IIIV)
- •history of an abnormal stress test
- •clinically significant medical or psychiatric illness
- •electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
- •metal in any part of the body including metal injury to the eye
- •past history of brain lesions (such as stroke)
- •seizures or unexplained spells of loss of consciousness
- •family history of epilepsy
- •physical therapy within 6 months of the study
- •symptomatic orthostatic hypotension at the screening visit
- •orthopedic and other movement-influencing diseases such as arthritis or total hip joint replacement
- •requirement for central nervous system active therapies (e.g. hypnotics, antidepressants, anxiolytics)
- •moderate or severe depression or apathy using the Geriatric depression scale and Apathy scale
- •taking anticholinesterase inhibitors
- •taking anticholinergic medication
- •PD dementia
- •Colorblindness
研究组 & 干预措施
Skill-Based Exercise
Participants assigned to this arm will complete the Skill-Based Exercise Intervention
干预措施: Skill-Based Exercise (Other)
Aerobic Exercise
Participants assigned to this arm will complete the Aerobic Exercise Intervention
干预措施: Aerobic Exercise (Other)
Social Contact Group
Participants assigned to this arm will complete the Social Contact Intervention
干预措施: Social Contact (Other)
结局指标
主要结局
Change in Context Dependent Motor Learning (CDML)
时间窗: at Baseline, after 12 week intervention, and at 12 week follow up visit
All subjects from each group will undergo a finger sequence motor learning task to determine exercise effects on EF as evaluated through improvement in the transfer of a learned motor task from one contextual setting to another.
Change in Tower of London Test
时间窗: at Baseline, after 12 week intervention, and at 12 week follow up visit
The Tower of London test will be used to evaluate executive function
Change in Wisconsin Card Sorting Test
时间窗: at Baseline, after 12 week intervention, and at 12 week follow up visit
The Wisconsin Card Sorting test will be used to evaluate executive function
Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)
时间窗: at Baseline, after 12 week intervention
A subset of subjects (60 representing 20 per group) will be invited to undergo fMRI studies at University of California, Los Angeles. Patients will perform a learned single finger-sequencing task (a condition of the CDML) with an additional secondary dual task (DT) component during an fMRI scan.
Change in D-KEFS Verbal Fluency Test
时间窗: at Baseline, after 12 week intervention, and at 12 week follow up visit
The D-KEFS Verbal Fluency test will be used to evaluate executive function
次要结局
- Change in Exercise Control Beliefs (BEL)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Geriatric Anxiety Inventory(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Parkinson Disease Questionnaire-39 (PDQ-39)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Activity Specific Balance Confidence (ABC) Scale(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Confidence in ability to maintain an exercise program (CONF)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Self-efficacy for Exercise Scale (EFFIC)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Body Mass Index(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Body Fat Percentage(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Adaptive Digit Ordering Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Apathy Scale(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Hooper Visual Organization Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Benton's Judgment of Line Orientation(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in California Verbal Learning Test- 2nd Edition (CVLT-II)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in WAIS-IV Similarities Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Frontal Systems Behavior Scale (FrSBe)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Motor Skill Fitness(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Cardiovascular Fitness(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Lifetime Total Physical Activity Questionnaire (LTPAQ)(at Baseline)
- Change in Global Physical Activity Questionnaire (GPAQ)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Mattis Dementia Rating Scale(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Geriatric Depression Scale(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Revised Activities of Daily Living Scale(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in the Frontal Systems Behavior Scale (FrSBe)(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in Boston Naming Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in D-KEFS Color Word Interference Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
- Change in WMS-II Visual Reproduction Test(at Baseline, after 12 week intervention, and at 12 week follow up visit)
研究者
Giselle Petzinger
Assistant Professor of Neurology
University of Southern California