Back to resultsiPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS (iPACES-PD)
Primary Purpose
Parkinson's Disease, PD, Mild Cognitive Impairment
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPACES (interactive Physical and Cognitive Exercise System)
PACE (Physical and Cognitive Exercise)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task, interactive, executive function
Eligibility Criteria
Inclusion Criteria: 50 years of age or older meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018) 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: already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk) significant history of cardiovascular problems significant history of stroke significant history of memory problems (e.g., dementia/Alzheimer's) significant history of other neurological condition (e.g., seizures, etc.) significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.) not prone to cybersickness (e.g., "car sickness" or problems with "screen time") cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)
Sites / Locations
- remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iPACES (interactive Physical and Cognitive Exercise System)
PACE (physical and cognitive exercise)
Arm Description
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) 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.
Outcomes
Primary Outcome Measures
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
everyday function
subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes
Secondary Outcome Measures
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)
visuospatial function
cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance
PD-ADLs
Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes
Full Information
NCT ID
NCT05810454
First Posted
March 27, 2023
Last Updated
April 11, 2023
Sponsor
iPACES LLC
Collaborators
Pacific Brain Health Center, 1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical College, Center for Balance, Mobility & Wellness at Gordon College
1. Study Identification
Unique Protocol Identification Number
NCT05810454
Brief Title
iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS
Acronym
iPACES-PD
Official Title
Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iPACES LLC
Collaborators
Pacific Brain Health Center, 1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical College, Center for Balance, Mobility & Wellness at Gordon College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, PD, Mild Cognitive Impairment, MCI
Keywords
Parkinson, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task, interactive, executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iPACES (interactive Physical and Cognitive Exercise System)
Arm Type
Experimental
Arm Description
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.
Arm Title
PACE (physical and cognitive exercise)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iPACES (interactive Physical and Cognitive Exercise System)
Other Intervention Name(s)
neuro-exergame
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PACE (Physical and Cognitive Exercise)
Intervention Description
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.
Primary Outcome Measure Information:
Title
executive function
Description
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
Time Frame
change from baseline to 3 months
Title
everyday function
Description
subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes
Time Frame
change from baseline to 3 months
Secondary Outcome Measure Information:
Title
biomarker
Description
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)
Time Frame
change from baseline to 3 months
Title
visuospatial function
Description
cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance
Time Frame
change from baseline to 3 months
Title
PD-ADLs
Description
Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes
Time Frame
change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
50 years of age or older
meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)
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:
already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
significant history of cardiovascular problems
significant history of stroke
significant history of memory problems (e.g., dementia/Alzheimer's)
significant history of other neurological condition (e.g., seizures, etc.)
significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DrVal Clinical Research Coordinator
Phone
737-747-2237
Email
support@myipaces.org
First Name & Middle Initial & Last Name or Official Title & Degree
self-enrollment option www.myipaces.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bob Gillen, PhD
Organizational Affiliation
iPACES LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cay Anderson-Hanley, PhD
Organizational Affiliation
iPACES LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DrVal Clinical Research Coordinator
Phone
737-747-2237
Email
support@myipaces.org
First Name & Middle Initial & Last Name & Degree
Cay Anderson-Hanley, PhD
First Name & Middle Initial & Last Name & Degree
Bob Gillen, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
de-identified data will be made available in downloadable form
IPD Sharing Time Frame
1-3 years depending upon pace of enrollment
IPD Sharing Access Criteria
IPD sharing access may be requested at support@myipaces.org
Citations:
PubMed Identifier
30200183
Citation
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.
Results Reference
result
PubMed Identifier
30233154
Citation
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.
Results Reference
result
PubMed Identifier
29780318
Citation
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.
Results Reference
result
PubMed Identifier
22261206
Citation
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.
Results Reference
result
PubMed Identifier
27337738
Citation
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.
Results Reference
result
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iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS
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