Trial Outcomes & Findings for Self-Administered Interactive Exercise Program (Tele-Exergame) (NCT NCT07072962)

Last Updated: 2025-08-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2025-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	TeleExergame Participants in the Tele-Exergame arm will use 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.
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Administered Interactive Exercise Program (Tele-Exergame)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TeleExergame n=15 Participants 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.
Age, Continuous	68.2 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Outcome measures

Outcome measures
Measure	TeleExergame n=12 Participants Participants iused 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.
Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline	9.7 percentage change Standard Deviation 10.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TeleExergame n=12 Participants Participants iused 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.
Acceptability	93.3 score on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	TeleExergame n=12 Participants Participants iused 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.
Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline	-52.4 percentage change Standard Deviation 40.3

Adverse Events

TeleExergame

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bijan Najafi

Baylor College of Medicine

Phone: 424-467-7127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee This is an NIH SBIR grant with BioSensics LLC as the prime awardee. A subaward contract agreement between BioSensics LLC and Baylor College of Medicine is in place, which may restrict the sharing of certain results deemed confidential.
Publication restrictions are in place

Restriction type: OTHER