CompletedNot Applicable

Self-Administered Interactive Exercise Program (Tele-Exergame)

United States15 participantsStarted 2021-03-21

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used a self-administered interactive exercise program done remotely — how realistic would that kind of setup be for me or my family member given our current tech comfort level and home situation?
2The trial measured cognitive function changes over just 6 weeks — is that a long enough window to tell us anything meaningful about whether this kind of program could actually help with mild cognitive impairment or early Alzheimer's?
3Since this trial has already completed, have any results been published yet, and if so, what did they actually show about whether the exercise program made a difference?
4This study is listed as Phase NA, which I understand means it may be more of a feasibility or pilot study — does that mean the safety and effectiveness aren't yet fully established compared to a later-phase trial?
5Given that this trial is already finished, are there any follow-up studies or similar active programs you'd recommend I look into instead, or would standard care be a better starting point right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline

Timeframe: Baseline and 6 weeks

Trial details

NCT IDNCT07072962

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31

Results submitted2025-07-22

View on ClinicalTrials.gov More Mild Cognitive Impairment (MCI) trials