Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

NCT05235113 | Active Not Recruiting FDA Device

• 2 other identifiers: 24-1331R44AG067909
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

Conditions

Dementia; Cognitive Impairment; Memory Loss; Mild Cognitive Impairment

Keywords

tele-exercise; exergame; tele-rehabilitation; Telehealth; telemedicine; virtual reality

Outcome Measures

Primary Outcomes (2)

• Change in Balance

  Change in balance from baseline to 12 weeks will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSen) to measure body sway.

  Baseline and 12 weeks

• Change in Cognitive Function

  Changes from baseline in cognitive function at 12 weeks. Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

  Baseline and 12 weeks

Secondary Outcomes (5)

• Change in Physical Activity

  Baseline and 12 weeks

• Change in Quality of Life

  Baseline and 12 weeks

• change in depression

  Baseline and 12 weeks

• Change in Fear of Falling

  Baseline and 12 weeks

• Change in Gait speed

  Baseline and 12 weeks

Other Outcomes (3)

• Supportive care acceptability

  Baseline and 12 weeks

• Adherence

  week 4, week 8, week 12

• intervention related dropout

  week 4, week 8, week 12

Study Arms (2)

Remote Exercise with tele-exergame

ACTIVE COMPARATOR

Subjects will perform exercises remotely twice a week with tele-exergaming platform.

Device: Tele-Exergame Platform

home-based exercise without technology

SHAM COMPARATOR

Subjects will perform exercises at home without tele-exergaming platform twice a week.

Device: No Tele-Exergame Platform

Interventions

Tele-Exergame Platform DEVICE

Subjects will perform exercises remotely twice a week with tele-exergaming platform.

Remote Exercise with tele-exergame

No Tele-Exergame Platform DEVICE

Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform.

home-based exercise without technology

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with diagnosed with dementia or cognitive impairment
• Living independently in a residential home with a caregiver/informant
• Able to walk at least 30 feet with or without assistance

You may not qualify if:

• Immobility or major mobility disorder or inability to engage safely in the proposed weight-bearing exercise program
• Diagnosed with severe cognitive impairment (MoCA score \< 16)
• Subjects with major hearing/visual impairment

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of California, Los Angeles: lead
• BioSensics: collaborator

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

Baylor College of Medicine

Houston, Texas, 77498, 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; Dementia; Memory Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will perform leg and foot exercises twice a week. The IG will use the Tele-exergaming platform, and the CG will do the exercises without the platform.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: February 11, 2022
• Study Start: November 3, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (2)