Exercise Targeting Cognitive Impairment in Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University of Southern California
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Context Dependent Motor Learning (CDML)
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Giselle Petzinger
Assistant Professor of Neurology
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Context Dependent Motor Learning (CDML)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)