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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). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.
A specific aim is to evaluate 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. |
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| 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) | change from baseline to 6 months |
| everyday function | subjective cognitive function in everyday living (e.g., Ecological Validity Scale) | change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| biomarker | biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor) | change from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IreLee Clinical Research Coordinator | Contact | 737-747-2237 | support@myipaces.org | |
| self-enrollment option www.myipaces.org | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Cay Anderson-Hanley, PhD | iPACES LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| remote trial conducted via video-conference/mail in-home all locations in the continental USA | Recruiting | 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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| OTHER |
participants are randomly assigned to either iPACES ("pedal-to-play") or PACE ("pedal-while-play") exergaming interventions to be completed 3-5x/wk for 6 months, then PACE crosses over to iPACES and all followed out to 1-year mark
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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. |
|
| 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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