NCT03069391

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

5.3 years

First QC Date

February 7, 2017

Last Update Submit

March 29, 2020

Conditions

Keywords

exerciseexergame

Outcome Measures

Primary Outcomes (1)

  • executive function composite score

    comprised of scores from Stroop, Trails, and Flanker

    change over time from baseline to 3 months

Secondary Outcomes (2)

  • brain-derived neurotrophic factor (BDNF)

    change over time from baseline to 3 months

  • Sit-Stand Test

    change over time in score from baseline to 3 months

Study Arms (2)

physical, cognitive, then interactive

ACTIVE COMPARATOR

physical exercise alone (PES) first, then iPACES

Behavioral: physical exercise alone (PES) firstDevice: interactive Physical and Cognitive Exercise (iPACES™)

cognitive, physical, then interactive

ACTIVE COMPARATOR

cognitive exercise alone (iCE) first, then iPACES

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

Interventions

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)

Also known as: PES
physical, cognitive, then interactive

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)

Also known as: iCE
cognitive, physical, then interactive

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)

Also known as: iPACES™
cognitive, physical, then interactivephysical, cognitive, then interactive

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • history of seizure
  • Parkinson's disease
  • significant dementia/memory loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Aging & Neuropsychology Lab @ Union College

Schenectady, New York, 12308, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionNeurocognitive DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesMental DisordersCognition DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cay Anderson-Hanley, PhD

    Union College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2017

First Posted

March 3, 2017

Study Start

March 4, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations