The Interactive Physical and Cognitive Exercise System

Aging Clinical Trial

— iPACES™  

Official title:

The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03069391
• Other study ID #: 16028
• Secondary ID: 1R41AG053120-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2020
• Source: Union College, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Cognitive Change
• Cognitive Dysfunction
• Cognitive Impairment
• MCI
• Mild Cognitive Impairment
• Neurocognitive Disorder
• Neurocognitive Disorders

Intervention

Behavioral:
• physical exercise alone (PES) first
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)

Device:
• cognitive exercise alone (iCE) first
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)
• interactive Physical and Cognitive Exercise (iPACES™)
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)

Locations

Country	Name	City	State
United States	Healthy Aging & Neuropsychology Lab @ Union College	Schenectady	New York

Sponsors (6)

Lead Sponsor	Collaborator
Union College, New York	1st Playable Productions, Albany Medical College, National Institute on Aging (NIA), Skidmore College, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 im — View 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 (iPACES(TM) v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	executive function composite score	comprised of scores from Stroop, Trails, and Flanker	change over time from baseline to 3 months
Secondary	brain-derived neurotrophic factor (BDNF)	change in amount in saliva sample over time (pg/ml) per ELISA	change over time from baseline to 3 months
Secondary	Sit-Stand Test	scored performance on time and technique to move from sitting on floor to standing	change over time in score from baseline to 3 months