Self-Administered Interactive Exercise Program (Tele-Exergame)

NCT07072962 | Completed Results

• 2 other identifiers: H-44913 - Phase IR44AG067909
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

exercise; interactive exercise; exergame; tele-rehabilitation; home-based exercise; telemedicine; wearables; cognitive impairment; dementia; balance; telehealth; Alzheimer's disease; gamification

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline

  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.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Acceptability

  week 6

• Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline

  baseline and week 6

Study Arms (1)

TeleExergame

EXPERIMENTAL

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.

Device: home-based self-administered interactive exercise

Interventions

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.

Also known as: Teleexergame

TeleExergame

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Aging (NIA): collaborator
• BioSensics: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 36498431 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Motor Activity; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Bijan Najafi
• Organization: Baylor College of Medicine

najafi.bijan@gmail.com

424-467-7127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants receive the same intervention: a self-administered home exercise program delivered via an interactive tablet-based system (Tele-Exergame) designed to provide supportive care for individuals with mild cognitive impairment or early dementia.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 18, 2025
• Study Start: March 21, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)