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

NCT ID: NCT05235113

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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This study aims to develop and validate a remote exercise intervention for individuals at risk of or experiencing dementia using a wearable sensor-enabled platform, called Tele-Exergame. This approach could preserve cognitive function, promote independent living, reduce costs related to cognitive-motor decline, and advance remote technology use for screening cognitive and motor performance in older adults. The findings are crucial for healthcare providers, clinicians, seniors, and caregivers.

100 participants will be randomly assigned to either the intervention or control group, both undergoing a 12-week daily home exercise program for at least cumulative active exercise of 30 minutes per week twice weekly. The intervention group will complete sessions remotely using Tele-exergame, while the control group will participate in home-based exercise without technology.

Conditions

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Mild Cognitive Impairment Dementia Cognitive Impairment Memory Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Remote Exercise with tele-exergame

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

Group Type ACTIVE_COMPARATOR

Tele-Exergame Platform

Intervention Type DEVICE

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

home-based exercise without technology

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

Group Type SHAM_COMPARATOR

No Tele-Exergame Platform

Intervention Type DEVICE

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

Interventions

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Tele-Exergame Platform

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

Intervention Type DEVICE

No Tele-Exergame Platform

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioSensics

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Bijan Najafi, PhD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA

Los Angeles, California, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status COMPLETED

Countries

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United States

Central Contacts

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Bijan Najafi, PhD

Role: CONTACT

(424) 467-7127

Alexis Noirot, BS

Role: CONTACT

310-267-2115

References

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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 BACKGROUND
PMID: 36498431 (View on PubMed)

Other Identifiers

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R44AG067909

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1331

Identifier Type: -

Identifier Source: org_study_id

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