Self-Administered Interactive Exercise Program (Tele-Exergame): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Self-Administered Interactive Exercise Program (Tele-Exergame) (NCT07072962), a na na study. The primary outcome is Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline.

2. Clinical Question

The clinical question is whether cognition changes from baseline to 6 weeks among participants with mild cognitive impairment, mild Alzheimer disease, or memory deficits who take part in a home-based, self-administered Tele-Exergame exercise program. This is a within-group question: participants received the intervention, and the registry record does not describe a concurrent comparison group. It therefore does not estimate how outcomes would have differed under another intervention or under care-as-usual alone.

The primary measure is a change over time within the enrolled group, not a treatment effect estimated against a control group. That distinction matters because cognitive scores can change for reasons other than the intervention, including ordinary variation in measurement and changes over time. Without a comparison group, the registry record cannot separate those possibilities from any change associated with participation in the program.

3. Trial Design

This is a completed Phase I feasibility study of the Tele-Exergame platform. The registry record lists Baylor College of Medicine as the sponsor, an enrollment of 15, and a single-group model. Allocation is recorded as NA, and masking is listed as none. No randomized assignment or separate control arm is described.

The intervention is a home-based, self-administered interactive exercise program. The arm description identifies a tablet-based program focused on foot and ankle mobility for older adults with cognitive impairment or mild dementia. The brief study summary describes a 6-week intervention with two 30-minute sessions per week, alongside care-as-usual. These features describe the planned study activity; they do not establish how many participants completed every session.

The primary outcome is percentage change in cognitive function at 6 weeks compared with baseline, assessed using the Montreal Cognitive Assessment. The stated secondary outcomes include acceptability, dropout rate, and changes in anxiety; the listed secondary outcome measures include acceptability and percentage change in anxiety at 6 weeks compared with baseline. The registry record lists three outcome measures, but does not report numerical outcome results.

The study start date is 2021-03-21, the primary completion date is 2022-01-31, and the status is completed. Completion status indicates that the registry lists the study as completed; it does not supply the missing outcome estimates or establish that all planned assessments were available for analysis. The analysis methods, participant flow, and number assessed at each time point are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percentage Change in Cognitive Function at 6 Weeks Compared to Baseline, measured over Baseline and 6 weeks.

The primary endpoint is percentage change in total Montreal Cognitive Assessment score from baseline to 6 weeks. The Montreal Cognitive Assessment, or MoCA, is described in the registry record as a validated 30-point screening tool designed to detect mild cognitive impairment and early dementia. It assesses memory, attention, language, visuospatial abilities, executive function, and orientation. Higher scores indicate better cognitive performance.

The percentage-change definition is the week 6 score minus the baseline score, divided by the baseline score, and multiplied by 100. The registry record states that a positive percentage indicates improved cognitive performance. Expressing change relative to baseline can make the scale of change easier to interpret in relation to a participant’s starting score. It also means that the calculation depends on that baseline value; the registry record does not report the participants’ baseline scores or the resulting percentage changes.

The MoCA is used as a broad cognitive screening measure across several domains. It is not a direct measure of every aspect of daily function, and the registry description does not identify a specific cognitive domain as the sole target. Although the endpoint is clearly defined, its numerical result, variability, and number of participants contributing paired baseline and week 6 assessments are not reported in the registry record. The endpoint definition therefore explains what was intended to be measured, but does not establish what change was observed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record specifies a continuous primary outcome reported as a mean, with standard deviation as the stated measure of dispersion. These choices describe how a group result may be summarized: the mean represents an average, while the standard deviation describes how spread out individual measurements are around that average. Neither statistic is reported numerically for the primary endpoint in the registry record, and the analysis method used to produce a result is not reported.

What does the primary outcome represent?

The endpoint is percentage change in MoCA score from baseline to 6 weeks. Each participant’s change is defined relative to that participant’s baseline score. A group mean of those changes, if reported, would describe the average percentage change among the participants included in the calculation. It would not describe every individual’s experience. Individual changes could differ from the mean, and the standard deviation would help describe that variation. The registry record does not give the observed mean, standard deviation, or participant-level results.

Why does a confidence interval matter?

In general, a confidence interval expresses the uncertainty around an estimated quantity. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. A confidence interval is not a guarantee that the true value lies within its limits. No confidence interval for the primary endpoint is reported in the registry record, so the precision of the estimated change cannot be assessed.

In general, a p-value evaluates how compatible the observed data are with a specified null hypothesis under a particular statistical model. It does not measure the size or importance of an effect, and it cannot correct for weaknesses in study design. The registry record lists no analyses, and no p-value or inferential test for the primary outcome is reported. No particular test should be assumed from the fact that the outcome is continuous or measured at baseline and week 6.

What does the single-group structure allow?

The design records outcomes in one intervention group rather than comparing outcomes across randomized groups. A baseline-to-week 6 change can describe how measurements differ over time among participants with data at both assessments. In general, however, that change does not isolate the effect of the intervention. Without a concurrent comparator, other influences on scores and ordinary measurement variation remain possible explanations. The registry record does not report an adjusted analysis or a design feature that would address those alternative explanations.

The registry record lists an enrollment of 15, but does not report the number with paired MoCA assessments or the number used in an outcome analysis. In general, a small analysis group can yield imprecise estimates, especially when individual outcomes vary. The degree of precision cannot be determined from enrollment alone; it depends on the actual analysis sample and observed variability, neither of which is reported for the primary endpoint.

How should planning illustrations be understood?

In general, sample-size planning illustrations describe the number of participants that would be needed under stated assumptions to detect a chosen effect with a chosen statistical approach. They are not observed results, and they are not evidence that a study had a particular probability of finding a statistically significant result. The registry record’s planning assumptions describe a two-arm illustration with equal allocation, a two-sided significance level of 0.05, a normal approximation, and effects expressed as fractions of an observed effect. The current study is listed as single-group, so those assumptions do not describe its recorded design. The planning illustration is not the trial’s own design justification, and no design-specific sample-size justification is reported in the registry record.

In general, over-dispersion means that observed variability exceeds what a chosen statistical model allows for. If a model underestimates variability, its uncertainty estimates may be too small. This is a general statistical concern, not a finding reported for this study: the registry record provides no primary outcome distribution or analysis with which to assess over-dispersion.

The registry record does not identify a statistical model, covariate adjustment, handling of repeated measurements, or method for calculating uncertainty. It would be inappropriate to infer a paired test or any other analysis simply from the baseline and week 6 schedule. The outcome definition and descriptive-statistic labels do not substitute for a complete statistical analysis plan or reported results.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("TeleExergame")
n   <- c(12)
m   <- c(9.7)
sp  <- c(10.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  TeleExergame  12  9.700  10.800  2.838  16.562

11. Multiplicity, Missing Data and Analysis Populations

The study identifies a primary cognitive outcome and several secondary outcomes, including acceptability, dropout rate, and anxiety. The registry record does not report a multiplicity strategy, such as a hierarchy for testing outcomes or an adjustment for multiple comparisons. When several outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately. In general, a prespecified strategy helps readers understand how multiple findings are to be interpreted. No such strategy is reported in the registry record, and no outcome test results are listed.

Methods for handling missing data are not reported in the registry record. In particular, the record does not state how incomplete MoCA assessments, missing week 6 measurements, or withdrawal from the program would be addressed in an analysis. The listed enrollment of 15 does not establish how many participants contributed data to each outcome or whether the analysis included only participants with complete measurements. The secondary outcome description includes dropout rate, but no numerical dropout result is reported.

Analysis populations are also not reported. The registry record does not say whether an outcome analysis was planned for all enrolled participants, participants who began the intervention, participants who completed it, or another defined group. These distinctions matter because the set of participants analyzed can affect the interpretation of a result. Without participant flow, missing-data methods, and analysis-population definitions, the completeness and representativeness of any outcome estimate cannot be evaluated from the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry safety entry lists 15 participants at risk for serious adverse events, 0 participants affected by serious adverse events, and 0 deaths in the TeleExergame group. It also lists 0 participants affected in the other adverse-event count. These are counts recorded for this group; the registry record does not give additional safety results or describe the observation period for these entries.

A count of 0 serious events in this group should be read narrowly. It means that the registry record reports no serious adverse events among the listed participants at risk. It does not establish that no non-serious symptoms or other events occurred, that every possible event was collected, or that the intervention is free of risk. The serious-event terms list is empty, so no specific serious event term is listed in the registry record.

The record does not describe the safety-monitoring procedures, how events were defined, or how long participants were followed for safety reporting. The figures therefore provide a limited account of recorded serious events, not a complete characterization of safety. They should be interpreted alongside the study’s small enrollment and the absence of fuller event-reporting details, rather than as a definitive estimate of risk.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a completed Phase I, single-group study evaluated a home-based, self-administered exercise program and specified percentage change in MoCA score from baseline to 6 weeks as its primary endpoint. It also describes the intervention schedule and lists secondary outcomes related to acceptability, dropout, and anxiety. These details make the study’s question and measurement approach clear.

The record does not report the numerical primary outcome or numerical secondary outcome results. It therefore does not show whether the group’s average MoCA score increased or decreased, how large any change was, or how much participants’ changes varied. The endpoint definition says how a positive percentage would be interpreted, but no observed percentage is given. The status of completed does not fill that gap.

The single-group design also limits what a change over time could mean. Even if a numerical baseline-to-week 6 change were available, that within-group comparison would not by itself establish that the intervention caused the change. There is no reported control group against which to distinguish intervention-associated change from other influences or measurement variation.

The serious-event entries report 0 serious events and 0 deaths among 15 participants listed at risk. Those entries are useful as a narrow description of the registry’s serious-event counts, but they do not show that all adverse events were absent or provide a detailed safety profile. The registry record also does not report missing-data handling, the number analyzed for each outcome, or a statistical analysis plan.

Accordingly, the record supports a description of the study’s design, intervention, and planned measures, but it does not support a quantitative conclusion about cognitive change, anxiety change, or acceptability. Any interpretation of effectiveness, precision, or comparative benefit would go beyond the results and design information reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between defining an outcome and reporting an outcome. The primary measure is described in detail: it uses MoCA scores at baseline and 6 weeks and specifies how percentage change is calculated. Yet without the numerical result, the direction, magnitude, and precision of change remain unknown. A clear endpoint definition is important, but it cannot replace the estimate and its uncertainty.

The single-group structure is also central to interpretation. Measuring participants before and after an intervention can describe change over time, but it does not provide a randomized contrast with an alternative. This distinction helps prevent a within-group change from being mistaken for a causal treatment effect. The registry record lists allocation as NA and a single-group model, so no like-for-like control comparison is reported.

The study’s feasibility focus and home-based format raise practical questions that are distinct from the primary cognitive endpoint. Acceptability and dropout are listed as secondary outcomes, but their numerical findings are not reported in the registry record. For a feasibility study, reporting participant flow and engagement would help readers understand how the intervention was taken up; those details are not available in the registry entry.

Finally, enrollment and event counts must be interpreted in context. The listed enrollment is 15, while the number contributing to each outcome is not reported. The serious-event count is 0, but this alone cannot characterize all safety events. Statistical interpretation depends not only on outcome definitions, but also on complete reporting of analyzed participants, estimates, uncertainty, missingness, and analysis methods.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most important limitation for interpreting the posted record is that it contains no numerical primary or secondary outcome results. The size and direction of cognitive change, its variability, and its precision cannot be evaluated. The registry record also lists no analyses, so there is no reported inferential result to interpret.

The study is single-group and has no separate comparator arm reported. Any baseline-to-week 6 change, if available, would not by itself distinguish an intervention-associated change from other time-related influences or measurement variation. Allocation is recorded as NA, and masking is listed as none.

The enrollment is 15, but the number of participants completing each assessment and contributing to each outcome analysis is not reported. Participant flow, reasons for missing measurements, handling of missing data, and analysis-population definitions are not reported in the registry record. Thus, the available entry cannot establish whether the endpoint reflects all enrolled participants or a subset.

The record does not report a statistical analysis plan, a method for estimating uncertainty, or an approach to multiplicity across the primary and secondary outcomes. It also does not give a design-specific sample-size justification. The planning assumptions listed for a two-arm illustration do not describe the single-group study design.

The serious adverse event counts are limited to the entries in the registry record. Safety-monitoring procedures, event definitions, and reporting duration are not described. In addition, the intervention description is brief and does not report participant-level adherence or session completion. These omissions limit assessment of both the completeness of the intervention exposure information and the scope of the safety record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Self-Administered Interactive Exercise Program (Tele-Exergame) — NCT07072962.
• Registry record last updated 2025-08-03; status last verified 2025-07.
• Results first posted 2025-08-03.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record identifies NCT07072962 as the study titled “Self-Administered Interactive Exercise Program (Tele-Exergame),” with the official title “TeleExergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine - Phase I.” Baylor College of Medicine is listed as sponsor. The study is marked completed, with a start date of 2021-03-21 and a primary completion date of 2022-01-31.

The study is listed as Phase I, single-group, with allocation recorded as NA and masking as none. Enrollment is 15. The intervention is a home-based, self-administered interactive exercise program, described as tablet-based and focused on foot and ankle mobility. The study summary describes two 30-minute sessions per week over 6 weeks.

The primary outcome is percentage change in MoCA score from baseline to 6 weeks. Acceptability, dropout rate, and anxiety are listed among the secondary outcomes. Numerical outcome results and analysis details are not reported in the registry record. The safety entry lists 0 serious events and 0 deaths among 15 participants at risk.