iPACES (interactive Physical and Cognitive Exercise System) for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
remote trial conducted via video-conference/mail in-home all locations in the continental USA, Clifton Park, NY
Dementia+4 More
iPACES (interactive Physical and Cognitive Exercise System) - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can improve cognitive function in people with mild cognitive impairment.

See full description

Eligible Conditions

  • Dementia
  • MCI
  • Mild Cognitive Impairment (MCI)
  • Alzheimer Disease

Treatment Effectiveness

Study Objectives

This trial is evaluating whether iPACES (interactive Physical and Cognitive Exercise System) will improve 2 primary outcomes and 1 secondary outcome in patients with Dementia. Measurement will happen over the course of change from baseline to 6 months.

Month 6
biomarker
everyday function
executive function

Trial Safety

Trial Design

2 Treatment Groups

PACE (physical and cognitive exercise)
1 of 2
iPACES (interactive Physical and Cognitive Exercise System)
1 of 2
Active Control
Experimental Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. IPACES (interactive Physical And Cognitive Exercise System) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

iPACES (interactive Physical and Cognitive Exercise System)
Device
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)
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to 6 months for reporting.

Closest Location

remote trial conducted via video-conference/mail in-home all locations in the continental USA - Clifton Park, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Anyone who is able to participate in the testing and read the text on the touch screen is considered to have adequate hearing, vision, and speech. show original
can read off of a small tablet screen
able to speak and read English fluently so they can complete interviews, surveys, and games. show original
The text states that in order to participate in the study, you need written approval from your primary care physician and cardiologist (if applicable). show original
for 30 minutes and burn about 270 calories You can burn about 270 calories by pedaling an under-table elliptical for 30 minutes. show original
People who are 50 years of age or older can benefit from SeniorPass show original
Someone who lives with you and is willing to exercise with you for the study. show original
One or both partners meets the criteria for mild cognitive impairment as assessed by a site staff member, doctor, or neuropsychologist, and confirmed by a score of 16-26 on the Montreal Cognitive Assessment. show original
Tablet surveys and videoconference evaluations are available for participation for one year. show original
willing and able to exercise 3-5 times per week for at least 6 months

Patient Q&A Section

What causes cognitive decline?

"Cognitive decline and disability are linked via the path of Alzheimer. Although age is the most important factor in the development of cognitive decline, other risk factors are likely to be operative too, namely, substance abuse, genetics, cardiovascular disease, and traumatic brain injury." - Anonymous Online Contributor

Unverified Answer

What are the signs of cognitive decline?

"Results from a recent paper provides further evidence that MCI is a clinically ndsign of cognitive decline. Furthermore, the occurrence of an nisolating symptom has positive repercussions for the progression of MCI." - Anonymous Online Contributor

Unverified Answer

Can cognitive decline be cured?

"Most people do not lose most of their cognitive function. In some cases this can be maintained with low-intensity cognitive training, and in others, this can be reduced and reversed by vigorous, intensive intervention. A meta-analysis of studies evaluating the effectiveness of intensive multimodal therapy for dementia patients is currently in progress." - Anonymous Online Contributor

Unverified Answer

How many people get cognitive decline a year in the United States?

"About 3.1 million people in the United States are diagnosed with some form of dementia annually. 1.3 million have Alzheimer's disease (AD). Half of all people who receive treatment for ADHD also have an underlying AD. About 0.6 million people in the United States have mild cognitive impairment (MCI) a year; about 2.5 million have mild AD a year. If a child has a parent who has AD or MCI, the child is likely to develop AD or dementia; if an parent has dementia, the child's risk increases threefold. If the child has the AD or dementia gene, the risk of AD or dementia doubles. About 0." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cognitive decline?

"Cognitive decline is difficult to treat, though some treatments have been found to improve cognitive function. Specifically, cognitive training has shown to improve cognitive ability in Alzheimer's disease, and has been shown benefit in other diseases as well.\n" - Anonymous Online Contributor

Unverified Answer

What is cognitive decline?

"The majority of individuals age 50+ have a variety of cognitive impairments, including executive dysfunction, memory decline, and attention, executive control deficits. There is also an association between cognitive decline and a decreased quality of life." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cognitive decline?

"Cognitive decline in late life is a common phenomenon that has negative implications regarding health. Due to our rapid aging society, we should develop a prevention for cognitive deterioration related to physical decline." - Anonymous Online Contributor

Unverified Answer

Has ipaces (interactive physical and cognitive exercise system) proven to be more effective than a placebo?

"Participants who used the ipages for 6 months experienced a greater improvement in cognitive and functional abilities compared to participants in the control group undergoing similar intensity of exercise at baseline. The use of the ipages was found to be an effective, easy and safe method for the provision of exercise on AD, and improvements in several cognitive abilities were observed at the end of the study." - Anonymous Online Contributor

Unverified Answer

Is ipaces (interactive physical and cognitive exercise system) safe for people?

"The IPCS is a safe and feasible intervention for older adults with good adherence. More research is required to establish the optimum dosage and duration of intervention." - Anonymous Online Contributor

Unverified Answer

How does ipaces (interactive physical and cognitive exercise system) work?

"Iples may be a viable method to rehabilitate people with cognitive impairments. This could be achieved by integrating ipcles into rehabilitative procedures. Additional studies, with a larger sample size, should be conducted to examine the applicability of ipiles for this group of people." - Anonymous Online Contributor

Unverified Answer

Is ipaces (interactive physical and cognitive exercise system) typically used in combination with any other treatments?

"When all of the treatments were equally effective for relieving pain or improving physical functioning; however, IPES and IPES-only treatments were no more effective than a placebo for improving cognitive functioning in this study. Results from a recent paper indicate that further work is needed to identify which treatments (IPES or IPES only, or IPES-only-plus-IPES) are best suited for enhancing cognition." - Anonymous Online Contributor

Unverified Answer

How serious can cognitive decline be?

"Cognitive impairment is related to physical function and to the degree of mobility in older persons. Older people presenting to the general population with less severe cognitive impairment may have significant savings in time and, if left untreated, could be living an unaltered life with disability, compared with those with more serious impairment. We suggest using a multifactorial approach to the management of the elderly and limiting falls to the frail and very elderly in order to achieve maximal clinical benefit and to avoid undue morbidity as an inevitable consequence of the aging process." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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