NCT07072962

Self-Administered Interactive Exercise Program (Tele-Exergame)

Completed NA Results posted Last updated 3 August 2025

What this trial tests

NA trial testing home-based self-administered interactive exercise in Mild Cognitive Impairment (MCI) in 15 participants. Completed in 31 January 2022.

Timeline

21 March 2021

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	21 March 2021
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	1 location across United States

Drugs / interventions tested

• home-based self-administered interactive exercise

Conditions studied

• Mild Cognitive Impairment (MCI) — all drugs for Mild Cognitive Impairment (MCI) →
• Mild Alzheimer Disease — all drugs for Mild Alzheimer Disease →
• Memory Deficits — all drugs for Memory Deficits →

Sponsor

Baylor College of Medicine

Who can join

50 and older, any sex, with Mild Cognitive Impairment (MCI) or Mild Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline Primary · 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

Group	Value	95% CI
TeleExergame	9.7	± 10.8

Acceptability Secondary · week 6

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 accep

Group	Value	95% CI
TeleExergame	93.3	± 17.4

Percentage Change in Anxiety Levels at 6 Weeks Compared to Baseline Secondary · baseline and week 6

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

Group	Value	95% CI
TeleExergame	-52.4	± 40.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.