NCT07072962

Self-Administered Interactive Exercise Program (Tele-Exergame)

TeleExergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine - Phase I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Mild Alzheimer Disease
• Memory Deficits

Interventions

Type	Name	Description
DEVICE	home-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.

Timeline

• Start date: 2021-03-21
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2025-07-18
• Last updated: 2025-08-03
• Results posted: 2025-08-03

Locations

1 site across 1 country: United States