SBIR-STTR Award

Alzheimer’s disease (AD) is a common condition that affects over 5 million older adults in the US. AD inhibits self-care and is associated with an increase in comorbidities, including diabetes, congestive heart failure, and cerebrovascular disease. One of the most important factors in maintaining autonomy with AD and in reducing comorbidities is participation in regular physical activity. Unfortunately, for individuals with mild cognitive impairment (MCI) or mild dementia due to AD, routine participation in physical activity is difficult due to safety concerns and the need for supervision, reminders, or guidance. A guided exercise system could make it easier for individuals with MCI or mild dementia to remain active, however, to our knowledge, there is no commercially available exercise system that is specifically designed to safely encourage routine physical activity in individuals with these conditions. Flint Rehab has previously developed Cycli, a low-profile, Bluetooth-enabled exercise cycle that would be well-suited for use by individuals with MCI or mild dementia to exercise. Flint Rehab has also previously developed a 10” touchscreen tablet called the Flint Tablet that runs a customized operating system to increase the ease-of- use of our software for individuals that are unfamiliar with technology. Cycli was originally developed for general wellness, but we hypothesize that, with the addition of a guided exercise application designed specifically for individuals with MCI or mild dementia, Cycli can safely increase the amount of physical activity performed by these individuals in routine life. Thus, for this Phase I project we propose to develop a novel guided exercise application for Cycli that runs on the Flint Tablet and is specifically designed to support individuals with MCI or mild dementia and their caregivers as they work together to maintain regular exercise habits. This approach has three key advantages. First, it will provide easy access to a safe and effective exercise modality for older individuals: stationary cycling. Second, it will be able to monitor a user’s exercise performance, increasing accountability. Third, it will motivate users to maintain regular exercise habits by using automated reminders, immersive audio and visual feedback during exercise, and social networking features. Our specific aims are to: 1) Perform structured interviews with clinical experts (N=10) to optimize the design of the Cycli guided exercise system; 2) Develop a prototype exercise guidance application for the Flint Tablet based on design requirements from Aim 1 and iterative expert feedback; and 3) Perform a usability study of Cycli with 10 individuals with MCI or mild dementia due to AD to determine if it can safely promote unsupervised physical activity. If this project is successful, it would be the first step in developing Cycli as a home exercise tool that could promote a healthier and more autonomous lifestyle for individuals with AD, leading to lower rates of comorbidities.

Public Health Relevance Statement:
This research is relevant to public health because it will increase the amount of physical activity performed by older individuals with mild cognitive impairment, thus reducing their risk of secondary complications. This will provide a pathway to a better life for millions of U.S citizens suffering from cognitive decline due to Alzheimer’s disease. Not only does regular physical activity improve an individual’s overall health, it also improves functional ability, increasing the standard of living of individuals with cognitive impairment and reducing the burden on their caregivers.

Project Terms:
Accountability; Activities of Daily Living; Affect; Alzheimer's Disease; Android; base; Bluetooth; Caregivers; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Cerebrovascular Disorders; Clinical; Comorbidity; Computer software; Congestive Heart Failure; cost; County; Custom; Data; Dementia; design; Development; Devices; Diabetes Mellitus; Elderly; Exercise; experience; Feedback; Habits; Health; Heart Rate; Home environment; Immersion Investigative Technique; Impaired cognition; improved; Individual; Interview; Life; Life Style; Living Standards; Maximum Heart Rate; mild cognitive impairment; mode of exercise; Monitor; novel; Operating System; Oranges; Participant; Pathway interactions; Performance; Phase; Physical activity; Population; Privatization; programs; prototype; Public Health; Race; Research; Resources; Risk; Running; Safety; Schedule; Scientist; Self Care; smartphone Application; Social Network; Structure; Supervision; System; Tablets; Technology; tool; touchscreen; usability; visual feedback; web server; Work

Alzheimer's disease (AD) affects over 5 million older adults in the US. AD is associated with accelerateddeterioration in physical function, resulting in a higher risks of falls, decline in mobility, reduced quality oflife, and loss of independence. Exercise interventions for individuals with AD or mild cognitive impairment(MCI) have shown promising improvements to overall health, physical function, and independence.Unfortunately, routine exercise is difficult to maintain for these individuals due to safety concerns and theneed for supervision and guidance. To address this need, we developed an exercise guidance app for ourtouchscreen Flint Tablet that connects to a sensorized, low-profile stationary cycle (Cycli). We evaluatedthe feasibility of this system in promoting home exercise in individuals with MCI or mild dementia in aPhase I SBIR. The exercise guidance app and overall approach received positive feedback. However, theCycli hardware had a number of critical issues that prevent it from being a viable home exercise optionfor this population (e.g. it created a potential tripping hazard and was not engaging for some users). Toaddress these limitations, we propose in Phase II to integrate the guided exercise app developed in PhaseI with our existing FitMi system, which is a wireless, sensorized at-home exercise device originallydeveloped for individuals with stroke. We refer to this new system here as FitMi AD. The existing FitMihardware includes a patented, multipurpose wireless input device (a "Puck") and a wearable wirelessinput device (a "Clip") that measure both movement and compression force. Thus, we believe that withappropriate, clinically informed design improvements, FitMi AD will facilitate home exercise in individualswith MCI or mild dementia due to AD. Specifically, in addition to incorporating the scheduling, tracking,and goal-setting features developed and validated in Phase I, FitMi AD will include a new library ofexercises from Exercise: A Guide from the National Institute on Aging (NIA). FitMi AD will also use real-time data from a Bluetooth heart rate monitor to automatically adjust the exercise intensity to achieve abeneficial level of exertion. Our specific aims for this Phase II project are to: Aim 1) Perform structuredinterviews with clinical experts and individuals with MCI or mild dementia due to AD and their caregiversto optimize the design of FitMi AD (n=25); Aim 2) Develop the FitMi AD exercise software with iterativeexpert and user feedback; Aim 3) Determine the safety and effectiveness of home-based exercise trainingwith FitMi AD in a randomized controlled trial with individuals with MCI or mild dementia due to AD(n=30). Our hypothesis is that participants who exercise at home with FitMi AD will show significantlygreater improvements in physical function than the control group. If successful, FitMi AD will be a safe,effective, and commercially viable home exercise tool for individuals with MCI or mild dementia due toAD, thus improving their quality of life and reducing the burden on caregivers.

Public Health Relevance Statement:
This research is relevant to public health because it will help support the development and commercialization of a novel home exercise system for individuals with mild cognitive impairment or mild dementia. FitMi AD will help improve overall health, physical function, and promote a more autonomous lifestyle, leading to improved quality of life and reduced burden on caregivers. This will provide a pathway to a better life for millions of U.S citizens suffering from cognitive decline due to Alzheimer's disease.

Project Terms:
<21+ years old>