Clinical trial NCT02267785: Exercise Targeting Cognitive Impairment in Parkinson's Disease
Official title: Exercise Targeting Cognitive Impairment in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: exercise
mild cognitive impairment
Parkinson's Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Parkinson Foundation
name: University of California, Los Angeles
First posted: 2014-10-17
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in Context Dependent Motor Learning (CDML)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)
timeFrame: at Baseline, after 12 week intervention
measure: Change in D-KEFS Verbal Fluency Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Tower of London Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Wisconsin Card Sorting Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Secondary outcomes:
measure: Change in Parkinson Disease Questionnaire-39 (PDQ-39)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Activity Specific Balance Confidence (ABC) Scale
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Confidence in ability to maintain an exercise program (CONF)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Exercise Control Beliefs (BEL)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Self-efficacy for Exercise Scale (EFFIC)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Frontal Systems Behavior Scale (FrSBe)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Motor Skill Fitness
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Cardiovascular Fitness
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Lifetime Total Physical Activity Questionnaire (LTPAQ)
timeFrame: at Baseline
measure: Change in Global Physical Activity Questionnaire (GPAQ)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Body Mass Index
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Body Fat Percentage
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Mattis Dementia Rating Scale
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Geriatric Depression Scale
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Geriatric Anxiety Inventory
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Apathy Scale
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Revised Activities of Daily Living Scale
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in the Frontal Systems Behavior Scale (FrSBe)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Adaptive Digit Ordering Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Hooper Visual Organization Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Benton's Judgment of Line Orientation
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in D-KEFS Color Word Interference Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in California Verbal Learning Test- 2nd Edition (CVLT-II)
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in WMS-II Visual Reproduction Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in WAIS-IV Similarities Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
measure: Change in Boston Naming Test
timeFrame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Giselle M Petzinger, MD
role: PRINCIPAL_INVESTIGATOR
References: