Mild Cognitive ImpairmentNCT05235113
Remote Game-based Exercise Program for Cognitive and Motor Function Improvement
A study testing Tele-Exergame Platform and No Tele-Exergame Platform in people with Mild Cognitive Impairment and Dementia, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Cognitive Impairment
- What is being tested?
- Tele-Exergame Platform and No Tele-Exergame Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77498
UCLA
Los Angeles, California, 90095
About this study
Official title: Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine
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.
Read the detailed description
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
- Mild Cognitive Impairment, Dementia, Cognitive Impairment, Memory Loss
- Being tested
- Tele-Exergame Platform, No Tele-Exergame Platform
- Keywords
- tele-exercise, exergame, tele-rehabilitation, Telehealth, telemedicine, virtual reality
- Medical subject headings
- Cognitive Dysfunction, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Exergame PlatformDevice
Subjects will perform exercises remotely twice a week with tele-exergaming platform.
No Tele-Exergame PlatformDevice
Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform.
| Study group | Role | What they receive |
|---|---|---|
| Remote Exercise with tele-exergame | Active comparator | Subjects will perform exercises remotely twice a week with tele-exergaming platform. Receives: Device: Tele-Exergame Platform |
| home-based exercise without technology | Sham comparator | Subjects will perform exercises at home without tele-exergaming platform twice a week. Receives: Device: No Tele-Exergame Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change in Physical Activity
Changes in physical activity from baseline to 12 weeks will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 48h baseline and 48 hour at 12 weeks.
Measured: Baseline and 12 weeks
Change in Quality of Life
Quality of life will be assessed using a validated questionnaire, called PROMIS Global-10.
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: Baseline and 12 weeks
change in depression
Changes in depression from baseline to 12 weeks will be assessed. Depression will be quantified by the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and 12 weeks. The CES-D consists of 20 items, and each item is scored on a scale of 0 to 3, with 0 representing "Rarely or none of the time" and 3 representing "Most or all of the time." The total score for the CES-D ranges from 0 to 60, with higher scores indicating a greater severity of depressive symptoms.
A score of 16 or higher is often considered as a cutoff point for identifying individuals who may be at risk for clinical depression. However, it is important to note that the CES-D is a screening tool, not a diagnostic tool, and a higher score should prompt further evaluation by a mental health professional.
Measured: Baseline and 12 weeks
Change in Fear of Falling
Changes in Fear of falling will be assessed by Short Falls Efficacy Scale International (FES I) questionnaire at 12 weeks and will be compared to baseline measurements. Scores range from 16 to 64, the higher the score the more concerned the subject is with falling.
Measured: Baseline and 12 weeks
Change in Gait speed
Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start3 Nov 2023
- Primary completion30 Apr 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Bijan Najafi, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235113
- Sponsor's protocol ID
- 24-1331
- Other IDs
- R44AG067909
- Status last verified
- May 2026
- First submitted
- 5 Nov 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36498431
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine
- ClinicalTrials.gov ID
- NCT05235113
- Acronym / sponsor ID
- 24-1331
- Conditions
- Mild Cognitive Impairment, Dementia, Cognitive Impairment, Memory Loss
- Keywords
- tele-exercise, exergame, tele-rehabilitation, Telehealth, telemedicine, virtual reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- BioSensics, National Institute on Aging (NIA)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote Exercise with tele-exergame | Active comparator | Device: Tele-Exergame PlatformSubjects will perform exercises remotely twice a week with tele-exergaming platform. |
| home-based exercise without technology | Sham comparator | Device: No Tele-Exergame PlatformSubjects will perform exercises at home without tele-exergaming platform twice a week. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Exergame PlatformSubjects will perform exercises remotely twice a week with tele-exergaming platform. | Device | Remote Exercise with tele-exergame |
| No Tele-Exergame PlatformSubjects will perform exercises in the home exercise twice a week without tele-exergaming platform. | Device | home-based exercise without technology |
Primary outcome
Change in Balance
Time frame: Baseline and 12 weeks
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.
Change in Cognitive Function
Time frame: Baseline and 12 weeks
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.
5 secondary outcomes
Change in Physical Activity
Time frame: Baseline and 12 weeks
Change in Quality of Life
Time frame: Baseline and 12 weeks
change in depression
Time frame: Baseline and 12 weeks
Change in Fear of Falling
Time frame: Baseline and 12 weeks
Change in Gait speed
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 36498431Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Exergame Platform and No Tele-Exergame Platform in people with Mild Cognitive Impairment and Dementia, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Balance (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.