Memory Deficits, Mild Alzheimer Disease, Mild Cognitive Impairment (MCI)
Conditions
Keywords
exercise, interactive exercise, exergame, tele-rehabilitation, home-based exercise, telemedicine, wearables, cognitive impairment, dementia, balance, telehealth, Alzheimer's disease, gamification
Brief summary
This longitudinal Phase I feasibility trial combines care-as-usual with a 6-week, single-arm exercise intervention using Tele-Exergame, an interactive, self-administered home-based exercise program aimed at improving cognitive-motor function in individuals with mild cognitive impairment (MCI) and dementia. Fifteen participants will complete two 30-minute sessions per week via the Tele-Exergame platform. Outcomes will be assessed at baseline and post-intervention, with the primary outcome being change in cognition. Secondary outcomes include acceptability, dropout rate, and changes in anxiety.
Detailed description
At the beginning of the 6-week in-home exergaming intervention using the proposed Tele-Exergame system, participants will complete baseline assessments to evaluate system acceptance, cognitive function, and anxiety levels. Acceptance will be measured using the Technology Acceptance Model (TAM) questionnaire-a validated, intention-based Likert scale tool assessing user satisfaction with technology-comprising 11 items (two on ease of use, seven on perceived benefit, and two on attitudes toward use). Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), and anxiety levels will be evaluated using the Beck Anxiety Inventory (BAI). Participants will be instructed to perform leg-raising or foot-flexion exercises, guided by the Tele-Exergame platform, for approximately 30 minutes twice per week over six consecutive weeks. Motion sensors (a motion sensor, which is part of of the Tele-Exergame system) will be worn on the upper leg for leg-raising exercises and on the foot for foot-flexion exercises. At the end of the 6-week intervention, participants will complete post-assessments for acceptance, cognition, and anxiety using the same measures.
Interventions
DEVICEhome-based self-administered interactive exercise
The Tele-Exergame system delivers a structured foot and ankle exercise program tailored for individuals with cognitive impairment or mild dementia to support balance and cognitive function. Exercises such as leg raising and foot flexion are guided through audio, visual, and text prompts on a tablet. A foot-mounted motion sensor provides real-time feedback to ensure proper range of motion, while exercise data are securely streamed to the cloud for remote monitoring of adherence. The system also includes a telemedicine interface to enable remote support and education when needed.
Sponsors
National Institute on Aging (NIA)
BioSensics
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All participants receive the same intervention: a self-administered home exercise program delivered via an interactive tablet-based system (Tele-Exergame) designed to provide supportive care for individuals with mild cognitive impairment or early dementia.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are 50 years of age or older, * Have a clinical diagnosis of mild cognitive impairment (MCI) or dementia, or a MoCA score of 25 or below indicating cognitive decline, * Are able to walk at least 20 meters, with or without assistance, * Live independently in a residential setting with access to a caregiver or informant, and * Are willing and able to provide informed consent
Exclusion criteria
* Have severe mobility limitations or conditions that prevent safe participation in a weight-bearing exercise program (e.g., double amputation, active foot ulcers, or significant pain in the back or lower extremities), * Have severe cognitive impairment that may limit their ability to interact with tablet. * Have a recent neurological condition (less than 6 months) known to affect cognition (e.g., stroke, Parkinson's disease, traumatic brain injury) * Have a significant psychiatric disorder, current substance abuse, or any medical condition that would interfere with study participation, or * Have major hearing or vision impairment limit their ability to interact with the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline | Baseline and 6 weeks | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point screening tool designed to detect mild cognitive impairment and early dementia. The MoCA evaluates multiple cognitive domains, including memory, attention, language, visuospatial abilities, executive function, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance. The MoCA will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total MoCA score from baseline to 6 weeks, calculated as: \[(Week 6 Score - Baseline Score) / Baseline Score\] × 100. A positive percentage indicates improved cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | week 6 | To evaluate participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire included 31 items: 15 assessed perceived ease of use, 11 evaluated perceived benefits, and 5 measured attitudes toward use. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), resulting in a total score range of 0 to 124. A score of 93 or higher was considered indicative of an acceptable level of program acceptance. |
| Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline | baseline and week 6 | Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), resulting in a total score ranging from 0 to 63, with higher scores indicating greater anxiety. The BAI will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total BAI score from baseline to 6 weeks, calculated as: \[(Week 6 Score - Baseline Score) / Baseline Score\] × 100. A negative percentage indicates a reduction in anxiety symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TeleExergame Participants used a home-based, tablet-guided exercise program, called TeleExergame, designed to improve foot and ankle mobility, balance, and cognitive function in older adults with cognitive impairment or mild dementia. The 6-week program consists of two 20-30 minute sessions per week, featuring safe, repetitive exercises such as foot flexion, ankle dorsiflexion, and seated marching. Instructions are provided through synchronized audio, visual, and text prompts. A foot-worn motion sensor tracks movements in real time, offering immediate feedback and securely transmitting adherence and performance data to a cloud server for remote monitoring. The system also supports telemedicine-based coaching and education when needed. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | TeleExergame |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point screening tool designed to detect mild cognitive impairment and early dementia. The MoCA evaluates multiple cognitive domains, including memory, attention, language, visuospatial abilities, executive function, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance. The MoCA will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total MoCA score from baseline to 6 weeks, calculated as: \[(Week 6 Score - Baseline Score) / Baseline Score\] × 100. A positive percentage indicates improved cognitive performance.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TeleExergame | Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline | 9.7 percentage change | Standard Deviation 10.8 |
Secondary
Acceptability
To evaluate participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire included 31 items: 15 assessed perceived ease of use, 11 evaluated perceived benefits, and 5 measured attitudes toward use. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), resulting in a total score range of 0 to 124. A score of 93 or higher was considered indicative of an acceptable level of program acceptance.
Time frame: week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TeleExergame | Acceptability | 93.3 score on a scale | Standard Deviation 17.4 |
Secondary
Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline
Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), resulting in a total score ranging from 0 to 63, with higher scores indicating greater anxiety. The BAI will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total BAI score from baseline to 6 weeks, calculated as: \[(Week 6 Score - Baseline Score) / Baseline Score\] × 100. A negative percentage indicates a reduction in anxiety symptoms
Time frame: baseline and week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TeleExergame | Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline | -52.4 percentage change | Standard Deviation 40.3 |