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Completed

NCT Number: NCT07072962

Self-Administered Interactive Exercise Program (Tele-Exergame)

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Memory Deficits Memory Disorders Mental Disorders Mild Alzheimer Disease Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home-based self-administered interactive exercise

Device

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.

Other names: Teleexergame

Primary outcomes

  1. Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline

    Time frame: 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 outcomes

  1. Acceptability

    Time frame: 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.

  2. Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • BioSensics
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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