Self-Administered Interactive Exercise Program (Tele-Exergame)

NCT ID: NCT07072962

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2022-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TeleExergame

Participants assigned to the Tele-Exergame arm will engage in a tablet-based, home-delivered exercise program focused on foot and ankle mobility, designed specifically for older adults with cognitive impairment or mild dementia. The intervention aims to enhance balance, mobility, and cognitive engagement through structured and gamified motor exercises.

Each session includes a sequence of guided exercises such as ankle dorsiflexion and plantarflexion and seated marching, with an emphasis on safe, repetitive movement. Sessions are conducted two times per week, lasting approximately 20-30 minutes each, over a period of 6 weeks.

Instructional cues are provided via synchronized audio, images, and text on a user-friendly tablet interface. A motion sensor worn on the foot tracks movement in real time, delivering instant feedback on range of motion and task completion. Exercise performance and adherence data are securely transmitted to a cloud-based server for remote remote monitoring.

Group Type: EXPERIMENTAL

home-based self-administered interactive exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Teleexergame

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

BioSensics

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

Park C, Mishra RK, York MK, Enriquez A, Lindsay A, Barchard G, Vaziri A, Najafi B. Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Int J Environ Res Public Health. 2022 Dec 6;19(23):16361. doi: 10.3390/ijerph192316361.

Reference Type: RESULT

PMID: 36498431 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R44AG067909

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-44913 - Phase I

Identifier Type: -

Identifier Source: org_study_id