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| Name | Class |
|---|---|
| Pacific Brain Health Center | UNKNOWN |
| 1st Playable Productions | OTHER |
| Adirondack Neuropsychological Associates | UNKNOWN |
| Albany Medical College |
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The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).
A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining the potentially unique contribution of combining mental and physical exercise in an interactive way: "pedal-to-play" (iPACES), as compared with non-interactive, but simultaneous: "pedal-while-play" (PACE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPACES (interactive Physical and Cognitive Exercise System) | Experimental | iPACES (interactive Physical and Cognitive Exercise System) involves a "pedal-to-play" neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations. |
|
| PACE (physical and cognitive exercise) | Active Comparator | PACE (Physical and Cognitive Exercise) involves a "pedal-while-play" experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPACES (interactive Physical and Cognitive Exercise System) | Device | iPACES involves a "pedal-to-play" neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations. |
| Measure | Description | Time Frame |
|---|---|---|
| executive function | cognitive function composite score from neuropsychological tests (e.g., Stroop); higher scores on the standardized composite would be centered around zero, and higher scores would indicate better performance | change from baseline to 3 months |
| everyday function | subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes | change from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| biomarker | biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., planned analyses include: BDNF/Brain Derived Neurotrophic Factor and IGF-1/Insulin-like Growth Factor) | change from baseline to 3 months |
| visuospatial function |
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Inclusion Criteria:
4. available for participation for one year (tablet surveys, videoconference evaluations) 5. willing and able to exercise 3-5 times per week for at least 6 months 6. can pedal an under-table elliptical 7. can read off of a small tablet screen 8. proficient in English (speaking and reading for completion of interview, surveys, game); Spanish language option anticipated soon 9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) 10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 11. can provide informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DrVal Clinical Research Coordinator | Contact | 737-747-2237 | support@myipaces.org | |
| self-enrollment option www.myipaces.org | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bob Gillen, PhD | iPACES LLC | Principal Investigator |
| Cay Anderson-Hanley, PhD | iPACES LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail | Clifton Park | New York | 12065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30200183 | Result | Wall K, Stark J, Schillaci A, Saulnier ET, McLaren E, Striegnitz K, Cohen BD, Arciero PJ, Kramer AF, Anderson-Hanley C. The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Exergame for Mild Cognitive Impairment (MCI). J Clin Med. 2018 Aug 30;7(9):249. doi: 10.3390/jcm7090249. | |
| 30233154 |
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de-identified data will be made available in downloadable form
1-3 years depending upon pace of enrollment
IPD sharing access may be requested at support@myipaces.org
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| Center for Balance, Mobility & Wellness at Gordon College | UNKNOWN |
participants are randomly assigned to either iPACES ("pedal-to-play") or PACE ("pedal-while-play") exergaming interventions to be completed 3-5x/wk for 3 months, then PACE crosses over to iPACES for 3 months, and all followed a final month
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|
| PACE (Physical and Cognitive Exercise) | Device | PACE involves a "pedal-while-play" experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations. |
|
cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance |
| change from baseline to 3 months |
| PD-ADLs | Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes | change from baseline to 3 months |
| Anderson-Hanley C, Stark J, Wall KM, VanBrakle M, Michel M, Maloney M, Barcelos N, Striegnitz K, Cohen BD, Kramer AF. The interactive Physical and Cognitive Exercise System (iPACES): effects of a 3-month in-home pilot clinical trial for mild cognitive impairment and caregivers. Clin Interv Aging. 2018 Sep 4;13:1565-1577. doi: 10.2147/CIA.S160756. eCollection 2018. |
| 29780318 | Result | Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018. |
| 22261206 | Result | Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016. |
| 27337738 | Result | Anderson-Hanley C, Maloney M, Barcelos N, Striegnitz K, Kramer A. Neuropsychological Benefits of Neuro-Exergaming for Older Adults: A Pilot Study of an Interactive Physical and Cognitive Exercise System (iPACES). J Aging Phys Act. 2017 Jan;25(1):73-83. doi: 10.1123/japa.2015-0261. Epub 2016 Aug 24. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |