Clinical trial NCT03069391: The Interactive Physical and Cognitive Exercise System
Official title: The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease, Early Onset
MCI
Aging
Mild Cognitive Impairment
Neurocognitive Disorder
Cognitive Impairment
Cognitive Change
Keywords: exercise
exergame
Lead sponsor: Union College, New York
Sponsor class: OTHER
Collaborators: name: 1st Playable Productions
name: Albany Medical College
name: Skidmore College
name: University of Illinois at Urbana-Champaign
name: National Institute on Aging (NIA)
First posted: 2017-03-03
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: executive function composite score
timeFrame: change over time from baseline to 3 months
Secondary outcomes:
measure: brain-derived neurotrophic factor (BDNF)
timeFrame: change over time from baseline to 3 months
measure: Sit-Stand Test
timeFrame: change over time in score from baseline to 3 months
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Healthy Aging & Neuropsychology Lab @ Union College
state: New York
Study officials:
affiliation: Union College
name: Cay Anderson-Hanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.