iPACES for Parkinson's Disease

(iPACES-PD Trial)

Overseen By self-enrollment option www.myipaces.org

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: iPACES LLC

Disqualifiers: Cardiovascular problems, Stroke, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a unique exercise program called iPACES (interactive Physical and Cognitive Exercise System) might help people with Parkinson's Disease improve cognitive function. Participants will use a pedal machine while engaging in interactive games on a tablet, either at home or another convenient location. The study compares this system with a similar program, PACE (Physical and Cognitive Exercise), where participants pedal and play games simultaneously but with less interactivity. It is designed for those with Parkinson's who experience mild cognitive impairment and can commit to regular exercise at home.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive health for those with Parkinson's.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the iPACES system is safe for persons with Parkinson's Disease?

Research has shown that iPACES, which combines physical and mental exercises, appears very promising. In earlier studies, participants with Parkinson’s Disease who used this system improved their balance and felt more confident about preventing falls, indicating it is generally well-tolerated. These studies did not report any serious side effects.

For PACE, which also includes exercise, research indicates that exercise is usually safe for people with Parkinson’s. Exercise plays an important role in managing Parkinson’s and typically does not cause major problems, though specific risks remain unclear. Overall, both iPACES and PACE seem to be safe options with potential benefits for those with Parkinson’s. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iPACES system for Parkinson's disease because it combines physical and mental exercises in a truly interactive way. Unlike standard treatments, which often focus on medication and physical therapy separately, iPACES offers a "pedal-to-play" neuro-exergame where users must pedal to control their progress in a game, enhancing both cognitive and physical engagement simultaneously. This innovative approach aims to stimulate the brain and body together, potentially improving motor skills and cognitive function more effectively than traditional methods. The PACE system, as an active comparator, provides a less interactive but still combined exercise experience, allowing researchers to assess the added benefits of true interactivity in iPACES.

What evidence suggests that iPACES and PACE could be effective for Parkinson's Disease?

Research shows that iPACES, an interactive exercise system, may help improve thinking skills. Previous studies found that using iPACES for three months led to noticeable improvements in skills like planning and focusing. This is particularly important for people with Parkinson's Disease, which often involves a decline in thinking abilities. In this trial, participants will receive either the iPACES treatment or the PACE treatment. The PACE treatment combines physical and mental exercises but is less interactive. While specific information about PACE is limited, general research has shown that physical exercise can benefit brain health. Both treatments in this trial aim to engage the brain and body, which may help slow the decline in thinking skills. ^{6 7 8 9 10}

Who Is on the Research Team?

Bob Gillen, PhD

Principal Investigator

iPACES LLC

Cay Anderson-Hanley, PhD

Principal Investigator

iPACES LLC

Are You a Good Fit for This Trial?

This trial is for people over 50 with mild cognitive impairment or Parkinson's Disease who can commit to a year-long study, exercise 3-5 times weekly for at least 6 months using an under-table elliptical, and are comfortable with English. They need approval from their doctor to exercise and must be able to use touch screens despite any tremors.

Inclusion Criteria

Proficient in English (speaking and reading for completion of interview, surveys, game)

Can provide informed consent

Meets criteria for MCI (Montreal Cognitive Assessment score between 16-26)

Exclusion Criteria

Already exercising at recommended levels

Significant history of memory problems (e.g., dementia/Alzheimer's)

Significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in neuro-exergaming with iPACES or PACE at home, 3-5 times per week for at least 6 months

6 months

Remote participation

Follow-up

Participants are monitored for cognitive and physical outcomes one month after the main intervention

1 month

What Are the Treatments Tested in This Trial?

Interventions

• iPACES (interactive Physical and Cognitive Exercise System)
• PACE (Physical and Cognitive Exercise)

Trial Overview The study tests the iPACES system, a neuro-exergaming setup designed for home use that combines physical and cognitive exercises. Participants will engage in these activities remotely using either personal devices or equipment provided by the study.

How Is the Trial Designed?

Group I: iPACES (interactive Physical and Cognitive Exercise System) Experimental Treatment 1 Intervention

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.

Group II: PACE (physical and cognitive exercise) Active Control 1 Intervention

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 Is Running the Clinical Trial?

iPACES LLC

Lead Sponsor

Trials

2

Recruited

240+

Adirondack Neuropsychological Associates

Collaborator

Trials

2

Recruited

240+

Albany Medical College

Collaborator

Trials

96

Recruited

12,700+

Center for Balance, Mobility & Wellness at Gordon College

Collaborator

Trials

1

Recruited

120+

Pacific Brain Health Center

Collaborator

Trials

2

Recruited

240+

1st Playable Productions

Collaborator

Trials

3

Recruited

270+

Published Research Related to This Trial

A tablet-based training program for Parkinson's disease patients was successfully tested over 9 months, helping them stay motivated and develop personalized training routines after inpatient treatment.

Patients reported positive aspects such as structured support and Parkinson's specificity, but also suggested improvements for better individualization and flexibility in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized tablet-based training program in the domestic setting following complex treatment of Parkinson's disease-Success factors and barriers]. Wagner, L., Deck, R.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14E8C00B4F89C4D27598B8961CAA4A01A2FFCEB861BF/project-details/10906190

Project Details Data from in-home pilot trials (v1 & v2), found executive function significantly improved after 3-months of pedaling-to-play in the iPACES neuro-exergame, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05810454

Study Details | NCT05810454 | iPACES v3 MCI NIA ... A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining the potentially unique contribution of combining ...

3. myipaces.org myipaces.org/

iPACES We aim to compare cognitive and biomarker outcomes from one-year of treatment intervention with one-year of synchronous, but non-interactive physical and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03069391

The Interactive Physical and Cognitive Exercise System Parkinson's disease; significant dementia/memory loss. Ages Eligible for Study. 50 Years and older ( Adult , Older Adult ). Sexes Eligible for Study. All.

5. neurologycongress.com neurologycongress.com/program/scientific-program/2023/neuro-exergaming-for-parkinson-s-clinic-observed-trend-of-cognitive-improvement-after-pedal-n-play-with-the-interactive-physical-and-cognitive-exercise-system-ipaces

Neuro-exergaming for parkinson's: Clinic-observed trend of ... Numerous studies support physical exercise for its effectiveness in improving brain health and quelling cognitive decline across a variety of neurological ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36602886/

Physical exercise for people with Parkinson's disease The evidence is very uncertain about the effect of physical exercise on the risk of adverse events (very low confidence). Across outcomes, we ...

7. jnnp.bmj.com jnnp.bmj.com/content/95/11/1077

Exercise as medicine in Parkinson's disease Exercise is safe and represents a cornerstone in PD rehabilitation, but exercise may have even more fundamental benefits that could change clinical practice.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05720468

Exercise for Cognitive Excellence in Parkinson's Disease This study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1877065720301214

Effect of different types of exercises on psychological and ... Physical and cognitive exercises seem to indicate neural and brain function benefits, which attenuate the progressive course of non-motor symptoms in PD [10], [ ...

10. nature.com nature.com/articles/s41531-022-00418-4

A systematic review and meta-analysis on effects of ... Aerobic exercise had beneficial effects in improving balance, gait (velocity and stride/step length), and motor function in PD patients.