Clinical trial NCT02231073: Exercise, Brain Imaging, Cognition, and Gait in Parkinsonism
Official title: Peripheral and Central Postural Disorders in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Freezing of gait
Idiopathic Parkinson's disease
Exercise
parkinsonism
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-09-04
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation.

Design: This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging.

Discussion: The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential.


Eligibility criteria: Inclusion criteria:

Aged 50-90 years old. No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease (iPD) or parkinsonism) that could significantly affect balance or gait .

Capable of following directions. iPD subjects: UK Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.

Parkinsonism subjects: Gait characterized by slow short steps, shuffling gait and may be wide-based, with FoG, postural instability.

Exclusion criteria:

Inability to stand or walk for 2 min without an assistive device Recent changes in medication Excessive use of alcohol or recreational drugs, Contraindications to MRI scans (eg, claustrophobia, metal in body) Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.

Parkinsonism subjects: iPD and Parkinson plus syndromes such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Syndrome, or Cerebellar Ataxia.

Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere withMRI scan.

Control subjects: Will be matched for age and gender to iPD and parkinsonism groups.

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Primary outcomes:
measure: Change in Mini-BESTest score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary outcomes:
measure: Change in MDS-UPDRS score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in New Freezing of Gait questionnaire (NFOGQ) score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in PDQ-39 score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in Activities of Balance Confidence (ABC) questionnaire score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in instrumented gait and balance measures
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Neural Imaging
timeFrame: Baseline
measure: Change in Cognitive measures
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Fay B Horak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King LA, Peterson DS, Mancini M, Carlson-Kuhta P, Fling BW, Smulders K, Nutt JG, Dale M, Carter J, Winters-Stone KM, Horak FB. Do cognitive measures and brain circuitry predict outcomes of exercise in Parkinson Disease: a randomized clinical trial. BMC Neurol. 2015 Oct 24;15:218. doi: 10.1186/s12883-015-0474-2.