The Interactive Physical and Cognitive Exercise System (iPACES™)
Primary Purpose
Alzheimer Disease, Early Onset, MCI, Aging
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physical exercise alone (PES) first
cognitive exercise alone (iCE) first
interactive Physical and Cognitive Exercise (iPACES™)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring exercise, exergame
Eligibility Criteria
Inclusion Criteria:
- co-residing older adults (e.g., spouses, partners, roommates, relatives)
- both at least 50 years of age
- normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease
- adequate vision and dexterity for on-screen assessments
- able to pedal an under-table elliptical
- permission of primary care provider and cardiologist (if applicable)
Exclusion Criteria:
- history of seizure
- Parkinson's disease
- significant dementia/memory loss
Sites / Locations
- Healthy Aging & Neuropsychology Lab @ Union College
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
physical, cognitive, then interactive
cognitive, physical, then interactive
Arm Description
physical exercise alone (PES) first, then iPACES
cognitive exercise alone (iCE) first, then iPACES
Outcomes
Primary Outcome Measures
executive function composite score
comprised of scores from Stroop, Trails, and Flanker
Secondary Outcome Measures
brain-derived neurotrophic factor (BDNF)
change in amount in saliva sample over time (pg/ml) per ELISA
Sit-Stand Test
scored performance on time and technique to move from sitting on floor to standing
Full Information
NCT ID
NCT03069391
First Posted
February 7, 2017
Last Updated
March 29, 2020
Sponsor
Union College, New York
Collaborators
1st Playable Productions, Albany Medical College, Skidmore College, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03069391
Brief Title
The Interactive Physical and Cognitive Exercise System
Acronym
iPACES™
Official Title
The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Union College, New York
Collaborators
1st Playable Productions, Albany Medical College, Skidmore College, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
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
This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset, MCI, Aging, Mild Cognitive Impairment, Neurocognitive Disorder, Cognitive Impairment, Cognitive Change
Keywords
exercise, exergame
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical, cognitive, then interactive
Arm Type
Active Comparator
Arm Description
physical exercise alone (PES) first, then iPACES
Arm Title
cognitive, physical, then interactive
Arm Type
Active Comparator
Arm Description
cognitive exercise alone (iCE) first, then iPACES
Intervention Type
Behavioral
Intervention Name(s)
physical exercise alone (PES) first
Other Intervention Name(s)
PES
Intervention Description
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
Intervention Type
Device
Intervention Name(s)
cognitive exercise alone (iCE) first
Other Intervention Name(s)
iCE
Intervention Description
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
Intervention Type
Device
Intervention Name(s)
interactive Physical and Cognitive Exercise (iPACES™)
Other Intervention Name(s)
iPACES™
Intervention Description
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
Primary Outcome Measure Information:
Title
executive function composite score
Description
comprised of scores from Stroop, Trails, and Flanker
Time Frame
change over time from baseline to 3 months
Secondary Outcome Measure Information:
Title
brain-derived neurotrophic factor (BDNF)
Description
change in amount in saliva sample over time (pg/ml) per ELISA
Time Frame
change over time from baseline to 3 months
Title
Sit-Stand Test
Description
scored performance on time and technique to move from sitting on floor to standing
Time Frame
change over time in score 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:
co-residing older adults (e.g., spouses, partners, roommates, relatives)
both at least 50 years of age
normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease
adequate vision and dexterity for on-screen assessments
able to pedal an under-table elliptical
permission of primary care provider and cardiologist (if applicable)
Exclusion Criteria:
history of seizure
Parkinson's disease
significant dementia/memory loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cay Anderson-Hanley, PhD
Organizational Affiliation
Union College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Aging & Neuropsychology Lab @ Union College
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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
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The Interactive Physical and Cognitive Exercise System
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