Mild Cognitive Impairment (MCI)NCT07072962
Self-Administered Interactive Exercise Program (Tele-Exergame)
A study testing home-based self-administered interactive exercise in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Alzheimer Disease, Memory Deficits
- What is being tested?
- home-based self-administered interactive exercise
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TeleExergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine - Phase I
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.
Read the 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.
- Being tested
- home-based self-administered interactive exercise
- Keywords
- exercise, interactive exercise, exergame, tele-rehabilitation, home-based exercise, telemedicine, wearables, cognitive impairment, dementia, balance, telehealth, Alzheimer's disease, gamification
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based self-administered interactive exerciseDevice
Also called Teleexergame
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: home-based self-administered interactive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Acceptability
To evaluate participant acceptance of the Tele-Exergame system, the Technology Acceptance Model (TAM) questionnaire was administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire included 31 items: 15 assessed perceived ease of use, 11 evaluated perceived benefits, and 5 measured attitudes toward use. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree), resulting in a total score range of 0 to 124. A score of 93 or higher was considered indicative of an acceptable level of program acceptance.
Measured: week 6
Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline
Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), resulting in a total score ranging from 0 to 63, with higher scores indicating greater anxiety. The BAI will be administered at baseline and at 6 weeks. The outcome will be reported as the percentage change in total BAI score from baseline to 6 weeks, calculated as:
[(Week 6 Score - Baseline Score) / Baseline Score] × 100. A negative percentage indicates a reduction in anxiety symptoms
Measured: baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start21 Mar 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), BioSensics
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072962
- Sponsor's protocol ID
- H-44913 - Phase I
- Other IDs
- R44AG067909
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was submitted as part of an NIH SBIR project with a subaward from BioSensics LLC. Individual-level data will be shared with permission from BioSensics LLC based on the contract agreement. However, aggregated results for all participants will be published and reported.
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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleExergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine - Phase I
- ClinicalTrials.gov ID
- NCT07072962
- Acronym / sponsor ID
- H-44913 - Phase I
- Keywords
- exercise, interactive exercise, exergame, tele-rehabilitation, home-based exercise, telemedicine, wearables, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), BioSensics
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TeleExergame | Experimental | Device: home-based self-administered interactive exerciseParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| home-based self-administered interactive exerciseAlso: TeleexergameThe 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. | Device | TeleExergame |
Primary outcome
Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline
Time frame: Baseline and 6 weeks
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.
2 secondary outcomes
Acceptability
Time frame: week 6
Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline
Time frame: baseline and week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No. This study was submitted as part of an NIH SBIR project with a subaward from BioSensics LLC. Individual-level data will be shared with permission from BioSensics LLC based on the contract agreement. However, aggregated results for all participants will be published and reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based self-administered interactive exercise in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by Baylor College of Medicine at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline (time frame: Baseline and 6 weeks). 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 NCT07072962, 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 3 Aug 2025.