N/A
N=15
Self-Administered Interactive Exercise Program (Tele-Exergame)
Mild Cognitive Impairment (MCI) · Mild Alzheimer Disease · Memory Deficits
Bottom Line
View on ClinicalTrials.gov: NCT07072962 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline — 9.7 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- home-based self-administered interactive exercise (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline |
9.7 | — |
| SECONDARY Acceptability |
93.3 | — |
| SECONDARY Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline |
-52.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT07072962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.