Self-Administered Interactive Exercise Program (Tele-Exergame)

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment (MCI); Mild Alzheimer Disease; Memory Deficits

• Registration Number: NCT07072962
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2021-03-21
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Study First Submitted: 2025-06-25
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acceptability	week 6	To assess participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based model commonly used to evaluate user satisfaction and acceptance of new technologies. The questionnaire consisted of eleven items: two questions assessed ease of use and user-friendliness, seven evaluated perceived usefulness, and two measured attitudes toward use. Each item was rated using a 5-point Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). The average score across items (ranging from 0 to 4) was calculated to quantify overall acceptability of the system.
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

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Los Angeles, California, United States