MCIiPACESNCT05009524
The Interactive Physical and Cognitive Exercise System (v3) for Mild Cognitive Impairment (MCI)
A study testing iPACES (interactive Physical and Cognitive Exercise System) and PACE (Physical and Cognitive Exercise) in people with MCI and Mild Cognitive Impairment, run by iPACES LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- MCI, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- iPACES (interactive Physical and Cognitive Exercise System) and PACE (Physical and Cognitive Exercise)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well
- self or partner 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)
- available for participation for one year (tablet surveys, videoconference evaluations)
- willing and able to exercise 3-5 times per week for at least 6 months
- can pedal an under-table elliptical
Show all 11Show fewer
- can read off of a small tablet screen
- proficient in English (speaking and reading for completion of interview, surveys, game)
- can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech)
- written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study
- can provide informed consent
Who cannot join
- 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, Parkinson's, etc.)
- tremor (idiopathic) 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)
Trial locations and contacts
1 site in 1 country.
self-enrollment option www.myipaces.org contact
United States1 site, 1 recruiting
- Recruiting
remote trial conducted via video-conference/mail in-home all locations in the continental USA
Clifton Park, New York, 12065
IreLee Clinical Research Coordinator, 737-747-2237, support@myipaces.org
About this study
Official title: The Interactive Physical and Cognitive Exercise System (iPACES v3) to Benefit Brain Health in Mild Cognitive Impairment (MCI): A Randomized Clinical Trial of Neuro-exergaming Pedal-to-play (iPACES) vs Pedal-while-play (PACE)
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). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.
Read the detailed description
A specific aim is to evaluate 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).
- Conditions
- MCI, Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Being tested
- iPACES (interactive Physical and Cognitive Exercise System), PACE (Physical and Cognitive Exercise)
- Keywords
- ADRD, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task, interactive
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPACES (interactive Physical and Cognitive Exercise System)Device
Also called neuro-exergame
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.
PACE (Physical and Cognitive Exercise)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| iPACES (interactive Physical and Cognitive Exercise System) | Experimental | 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. Receives: Device: iPACES (interactive Physical and Cognitive Exercise System) |
| PACE (physical and cognitive exercise) | Active comparator | 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. Receives: Device: PACE (Physical and Cognitive Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
executive function
cognitive function composite score from neuropsychological tests (e.g., Stroop)
Measured: change from baseline to 6 months
everyday function
subjective cognitive function in everyday living (e.g., Ecological Validity Scale)
Measured: change from baseline to 6 months
Secondary outcomes (1)
biomarker
biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start23 Aug 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 6 months, then PACE crosses over to iPACES and all followed out to 1-year mark
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iPACES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Brain Health Center, 1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical College
- Responsible party
- Sponsor
- Investigators
- Cay Anderson-Hanley, PhD, Principal investigator, iPACES LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009524
- Sponsor's protocol ID
- NIA1R44AG071063
- Acronym
- iPACES
- Status last verified
- Nov 2021
- First submitted
- 23 Jul 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified data will be made available in downloadable form
Publications
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.
PubMed 30200183Anderson-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.
PubMed 30233154Anderson-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.
PubMed 29780318Anderson-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.
PubMed 22261206Anderson-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.
PubMed 27337738
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interactive Physical and Cognitive Exercise System (iPACES v3) to Benefit Brain Health in Mild Cognitive Impairment (MCI): A Randomized Clinical Trial of Neuro-exergaming Pedal-to-play (iPACES) vs Pedal-while-play (PACE)
- ClinicalTrials.gov ID
- NCT05009524
- Acronym / sponsor ID
- iPACES / NIA1R44AG071063
- Conditions
- MCI, Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Keywords
- ADRD, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- iPACES LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pacific Brain Health Center, 1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical College
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.
Detailed description
A specific aim is to evaluate 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 6 months, then PACE crosses over to iPACES and all followed out to 1-year mark
| Arm | Type | Receives |
|---|---|---|
| iPACES (interactive Physical and Cognitive Exercise System) | Experimental | Device: iPACES (interactive Physical and Cognitive Exercise System)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) | Active comparator | Device: PACE (Physical and Cognitive Exercise)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 50 years of age or older
- co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well
- self or partner 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)
- available for participation for one year (tablet surveys, videoconference evaluations)
- willing and able to exercise 3-5 times per week for at least 6 months
Key exclusion criteria (8 listed)
- 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, Parkinson's, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPACES (interactive Physical and Cognitive Exercise System)Also: neuro-exergameiPACES 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. | Device | iPACES (interactive Physical and Cognitive Exercise System) |
| PACE (Physical and Cognitive Exercise)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. | Device | PACE (physical and cognitive exercise) |
Primary outcome
executive function
Time frame: change from baseline to 6 months
cognitive function composite score from neuropsychological tests (e.g., Stroop)
everyday function
Time frame: change from baseline to 6 months
subjective cognitive function in everyday living (e.g., Ecological Validity Scale)
1 secondary outcome
biomarker
Time frame: change from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Results publication: PubMed 30200183Wall 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 publication: PubMed 30233154Anderson-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 publication: PubMed 29780318Anderson-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 publication: PubMed 22261206Anderson-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 publication: PubMed 27337738Anderson-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.
- Individual participant dataSharing planned: Yes. de-identified data will be made available in downloadable form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
self-enrollment option www.myipaces.org contact
Cay Anderson-Hanley, PhD principal investigator
iPACES LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPACES (interactive Physical and Cognitive Exercise System) and PACE (Physical and Cognitive Exercise) in people with MCI and Mild Cognitive Impairment, run by iPACES LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IreLee Clinical Research Coordinator (737-747-2237, support@myipaces.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
executive function (time frame: change from baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009524, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.