ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise, Brain Imaging, Cognition, and Gait in Parkinsonism (EEforPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02231073
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Fay B. Horak, Oregon Health and Science University

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Exercise and Education for Parkinson's Disease Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Peripheral and Central Postural Disorders in the Elderly
Study Start Date : August 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise: Agility Boot Camp-Cognitive
Subjects will participate in an 80-minute, group (6 per group) exercise session led by a certified exercise trainer knowledgeable in the Agility Boot Camp-Cognitive (ABC-C) program for 3x/week for 6 weeks. The exercise protocol is an adaptation of our Agility Boot Camp (ABC) exercise program for PD. The exercises are designed as a circuit to challenge movement-skills known to be impaired in PD. Stations will include: Gait training, PWR Moves ©, Agility course, Lunges, Boxing and Tai Chi. Each activity was chosen for its inherent focus on multi-directional movements, dynamic postural transitions, axial mobility, big movements and whole body motor sequencing. Each station (10-20 minutes) has 3 possible progression levels, based on: (1) divided attention with secondary cognitive tasks, (2) response inhibition, (3) limiting external sensory cues, and (4) increasing speed and resistance.
Behavioral: Exercise and Education for Parkinson's Disease
Exercise and Education for Parkinson's Disease for 6 week cross-over intervention.

Active Comparator: Education: Living with Parkinson's disease
The Education arm is a chronic disease education program to teach patients how to live better with their chronic condition. It was developed by our research team to be specific for people with Parkinson's disease. It will include content and discussion of topics such as sleep, nutrition, and medication management. Classes will consist of a group of subjects (up to 6) meeting with the trainer for 90-minute session, once a week for six weeks. In order to match dose of the education intervention with the exercise intervention, participants will be provided relaxation tapes to be used at home 5 times per week for 30 minutes for an overall education dose of 240 minutes; similar to the exercise dose.
Behavioral: Exercise and Education for Parkinson's Disease
Exercise and Education for Parkinson's Disease for 6 week cross-over intervention.




Primary Outcome Measures :
  1. Change in Mini-BESTest score [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    The Mini-BESTest assesses dynamic balance via a 14-item test that measures multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait.


Secondary Outcome Measures :
  1. Change in MDS-UPDRS score [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    The Unified Parkinson's Disease Rating Scale Motor Subscale III is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups, they will use the Postural Instability and Gait Disability(PIGD) Subscore (Items 27-30) as a covariate in data analysis.

  2. Change in New Freezing of Gait questionnaire (NFOGQ) score [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    The New FoG of Gait Questionnaire will be used to identify 'freezers' (score >3). NFOGQ is a self-report measure that begins with the presentation of a short (30-s) video to illustrate FoG during walking turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.

  3. Change in PDQ-39 score [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    the Parkinson's Disease Quality of Life questionnaire with 39 questions reflecting 8 domains of quality of life (Mobility, ADL's, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels has been established. The PDQ will reflect limitations to participation in community mobility.

  4. Change in Activities of Balance Confidence (ABC) questionnaire score [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    Activities of Balance Confidence (ABC) questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator, walking in a parking lot and replacing a light. Subjects indicate their confidence from 0% to 100% they have in their balance when they imagine doing these tasks. A score of 80% indicates an average level of physical functioning for older adults.

  5. Change in instrumented gait and balance measures [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]

    Balance: Postural sway during quiet stance with and without a cognitive task. Gait: Spatial and temporal gait metrics will be collected during walking, while wearing the Opal inertial sensors, with and without a cognitive task.

    Turning: Smoothness of turning measure during 1 min turning in place (360 degree) and turns during 2 min walk, with and without a cognitive task.


  6. Neural Imaging [ Time Frame: Baseline ]

    DTI: High angular resolution diffusion imaging to assess white matter microstructure. Structural connectivity of the locomotor network will be assessed using probabilistic tractography.

    rsfcMRI: An indirect assessment of communication between spatially disparate neural regions. Analysis is restricted to neural regions comprising the locomotor network including the supplementary motor area, subthalamic nuclei, mesencephalic locomotor regions (pedunculopontine and cuneiform nuclei), and the midline cerebellar locomotor region


  7. Change in Cognitive measures [ Time Frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2) ]
    A battery of tests to measure different cognitive domains: inhibition (stroop, flankers, go/nogo, stop signal), shifting (set-shifting, trail making), updating (dot counting task), visual-spatial (judgement of line orientation), general cognition (SCOPA-COG), and other (social norms questionnaire, social behavior rating scale, simple reaction time test).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231073


Contacts
Contact: Laurie King, PhD 503-418-2602 kingla@ohsu.edu
Contact: Patty Carlson-Kuhta, PhD 503-418-2602 carlsonp@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Fay B Horak, PhD, PT    503-418-2602    horakf@ohsu.edu   
Principal Investigator: Fay Horak         
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Fay B Horak, PhD Oregon Health and Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fay B. Horak, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02231073     History of Changes
Other Study ID Numbers: 4131
2R01AG006457 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fay B. Horak, Oregon Health and Science University:
Freezing of gait
Idiopathic Parkinson's disease
Exercise
parkinsonism

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases