This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults (NCT04534686), a randomized na study. The primary outcome is Change in 30-second Chair Stand Performance.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04534686 |
| Phase | NA |
| Condition | Frail Older Adults |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Illinois Chicago |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns frail older adults. The primary-outcome description says that 13 participants in the CogXergaming group and 14 in the Matter of Balance group completed the study and had data analyzed for that endpoint.
Intervention
CogXergaming was described as cognitive-motor balance training using commercially available Wii-Fit Nintendo equipment and a mouse in conjunction with cognitive training. The record describes 18 sessions over six weeks, delivered in a tapering manner; the remaining session-duration description is incomplete.
Comparator
The comparison group received Matter of Balance Training. Its description specifies one session a week for 2 hours/day over 8 weeks.
Primary question
The primary outcome is change in 30-second Chair Stand Performance, measured as the number of repetitions. The registry record does not report numerical results for this outcome or an estimate of the difference between groups.
The clinical question is whether the two training approaches differ in change in chair-stand performance among frail older adults enrolled in this trial. The study’s broader rationale concerns physical function, cognitive function, mobility, and quality of life, but the listed primary outcome is specifically a chair-stand test of leg strength and endurance. It does not by itself measure every aspect of those broader aims.
The registry describes a randomized comparison, but the endpoint timing differed by group: the immediate post-training assessment was at Week 8 for group A and Week 10 for group B, following baseline assessment at Week 0. Consequently, the comparison concerns measured change over each group’s training schedule, not a shared post-training calendar week. The record does not report a numerical outcome estimate, uncertainty interval, or test of the between-group contrast, so the direction and precision of any comparative result cannot be determined from the registry record.
3. Trial Design
The registry identifies NCT04534686 as a completed, randomized, parallel-group study sponsored by the University of Illinois Chicago. Its title is “CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults.” The record lists an enrollment of 49 and identifies frail older adults as the study condition. The phase is listed as NA. Masking is listed as none.
Participants were assigned to CogXergaming or Matter of Balance Training. The CogXergaming description says participants received cognitive-motor balance training with commercially available Wii-Fit Nintendo equipment and a mouse, combined with cognitive training. It describes 18 sessions delivered in a tapering manner over six weeks. The description is cut off after “60-90 minutes of traini,” so the full duration details are not reported in the registry record. The Matter of Balance description specifies one session a week for 2 hours/day over 8 weeks.
The primary outcome was assessed at baseline, labeled Week 0, and immediately after training. The listed post-training timing is Week 8 for group A and Week 10 for group B. The primary-outcome description reports that 13 CogXergaming participants and 14 Matter of Balance participants completed the study and had data analyzed for this endpoint. These endpoint-specific numbers do not account for the full enrollment listed in the study record; reasons for the difference are not reported in the registry record.
The registry lists Berg Balance Scale, change in physical activity level by questionnaires, and change in physical activity level as secondary outcomes. It also lists 28 outcome measures. A detailed statistical analysis plan, allocation procedure, sample-size justification, and interim-analysis information are not reported in the registry record. The record is marked completed, but completion status alone does not establish what statistical analyses were carried out or how missing observations were handled.
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.
Baseline Measurement
| Stage | CogXergaming | Matter of Balance Training |
|---|---|---|
| STARTED | 22 | 23 |
| Mid-intervention | 18 | 18 |
| COMPLETED | 15 | 16 |
| NOT COMPLETED | 7 | 7 |
Reasons for not completing this period:
| Reason | CogXergaming | Matter of Balance Training |
|---|---|---|
| Lost to Follow-up | 4 | 6 |
| Withdrawal by Subject | 3 | 1 |
Intervention
| Stage | CogXergaming | Matter of Balance Training |
|---|---|---|
| STARTED | 15 | 16 |
| COMPLETED | 13 | 14 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | CogXergaming | Matter of Balance Training |
|---|---|---|
| Withdrawal by Subject | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: 13 participants in the Coxergaming and 14 in the Matter of Balance group completed the study and data was analyzed for these participants.
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.
| Characteristic | Unit | CogXergaming | Matter of Balance Training | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 23 | 45 | |
| Age, Continuous | years | 72.15 (SD 6.03) | 71.83 (SD 5.98) | 72.13 (SD 5.84) |
| Sex: Female, Male: Female | Participants | 16 | 14 | 30 |
| Sex: Female, Male: Male | Participants | 6 | 9 | 15 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 4 | 4 | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 8 | 18 |
| Race (NIH/OMB): White | Participants | 8 | 11 | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Montreal Cognitive Assessment | units on a scale | 27.34 (SD 5.01) | 27.60 (SD 4.82) | 27.36 (SD 4.82) |
6. Primary Endpoint
The registry lists the primary outcome as Change in 30-second Chair Stand Performance, measured over Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | number of repetitions |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in 30-second Chair Stand Performance, recorded as the number of repetitions. The test assesses leg strength and endurance. Participants sit in the middle of a sturdy chair with feet flat on the floor and arms crossed against the chest, then stand fully and sit back down repeatedly during the 30-second test. Research personnel monitored the test remotely during a Zoom meeting. The registry states that higher values indicate better performance.
A chair-stand test is a functional measure: it captures repeated sit-to-stand performance rather than muscle strength in isolation. Repeatedly rising from a chair requires lower-body effort and the ability to complete the movement over the test interval. The registry’s stated reason for using the test is to assess leg strength and endurance. Its described practical requirements—a sturdy chair and remote observation—also make the assessment feasible in a home setting, according to the record.
The endpoint is called change because measurements were scheduled at baseline and immediately after training. However, the registry record does not report the group means, standard deviations, individual changes, or a between-group estimate. It also does not state how change was calculated or how the measurements were analyzed. The different post-training weeks—Week 8 for group A and Week 10 for group B—are relevant context for interpreting any change comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable functional endpoint and gives its measurement schedule, but does not report numerical results for the primary outcome. It therefore does not establish the average change in chair-stand performance in either group, the difference in change between groups, or the precision of that difference. No conclusion about the comparative outcome can be drawn from the endpoint description alone.
The endpoint is a continuous measure summarized in the record as a mean with standard deviation. Those summaries would describe the average repetitions and the spread of observed values within a group. A comparison of group means would address whether average performance differed, while an estimate of change would address how measurements shifted from baseline. These are distinct questions; the registry record does not give the numerical summaries or specify the analysis used to answer either one.
The study is described as randomized and parallel-group, which establishes the broad design. Randomization is intended, in general, to make treatment groups comparable at assignment, but it does not guarantee that every characteristic is balanced in a particular trial. The record does not describe the randomization procedure, baseline characteristics, or any adjustment strategy. With outcome data reported for 13 participants in CogXergaming and 14 in Matter of Balance, the endpoint information pertains to those analyzed participants, not automatically to everyone enrolled.
The timing also matters. Baseline was labeled Week 0, while immediate post-training measurement was at Week 8 for group A and Week 10 for group B. As a result, any change reflects measurements made on the schedules listed for the respective groups. The registry does not report whether the timing difference was incorporated into a statistical model or how it was considered in interpretation.
The record identifies multiple outcome measures and the primary outcome has several categories or time points rather than one reduced comparison. It lists 28 outcome measures, but no analysis entries. Without a reported primary comparison, uncertainty interval, or analysis description, readers cannot assess the magnitude, statistical precision, or robustness of a treatment contrast. The absence of reported outcome estimates is not evidence that the groups had identical results; it means the registry record does not allow their numerical comparison.
9. Statistical Methods Explained
General explanation: A continuous outcome is measured on a scale where values can take a range of possible amounts. The chair-stand endpoint is the number of repetitions completed in the test. The registry says the outcome is summarized using a mean and standard deviation. A mean describes the average observed value; a standard deviation describes how dispersed observations are around that average. Neither summary alone indicates how precisely a group mean is estimated or whether groups differ.
General explanation: A change analysis uses measurements taken at different times to describe how an outcome shifts. A treatment comparison may then compare average changes between groups, or may compare post-training values while accounting for baseline measurements. These approaches do not always produce the same estimate, and their interpretation depends on the chosen model and assumptions. The registry record reports baseline and immediate post-training assessments, but does not say how change was calculated or which analysis was used.
General explanation: A confidence interval describes a range of values compatible with the data under a statistical model and conveys uncertainty around an estimate. A narrow interval indicates more precise estimation than a wide interval, all else equal. A p-value addresses the compatibility of observed data with a specified null hypothesis and model; it is not a measure of effect size or practical importance. No confidence interval, p-value, or between-group effect estimate for the primary outcome is reported in the registry record.
General explanation: Random assignment and analysis are separate parts of a trial. Randomization describes how participants are assigned; analysis describes how outcome data are used to estimate a contrast. A parallel-group design compares groups assigned to different interventions, rather than having each participant receive both interventions in sequence. The registry identifies randomized allocation and a parallel model, but does not describe the allocation sequence, concealment, or statistical model.
General explanation: Repeated measurements can be analyzed in more than one way. A model may compare changes, account for baseline values, or model measurements over time. If observations from the same participant are included together, their statistical dependence needs to be considered. The appropriate approach depends on the study question and data structure. The record does not identify a repeated-measures model, baseline-adjustment method, or other specific analysis for the chair-stand endpoint.
General explanation: Missing outcome data can affect interpretation when the participants with observed outcomes differ from those without observed outcomes. An analysis restricted to participants with measurements may be informative, but its interpretation depends on why observations are missing and on the analysis plan. The primary-outcome description says 13 participants in CogXergaming and 14 in Matter of Balance completed the study and had data analyzed. The record does not explain the difference between those endpoint counts and the overall enrollment of 49, give reasons for missing data, or describe imputation or sensitivity analyses.
General explanation: Over-dispersion occurs when variability in data is greater than assumed by a statistical model. It can make standard errors too small if the model fails to allow for the extra variability. The listed primary endpoint is a count of repetitions, but the registry does not describe a count-data model or report a dispersion assessment. Since the record labels the outcome as a mean of a continuous measure with standard deviation, it would be inappropriate to assume a particular count model was used.
General explanation: Multiplicity arises when several outcomes, time points, or comparisons are examined. The more analyses considered, the more important it is to know which question was designated primary and whether any adjustment or hierarchical strategy was planned. The registry lists 28 outcome measures and several primary-outcome categories or time points, but does not report a multiplicity strategy. Its statistical analysis plan is not reported in the registry record.
The registry describes sample-size assumptions for planning illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It specifies that such illustrations are planning exercises, not observed power. The record does not provide a trial-specific sample-size justification, and the planning assumptions should not be treated as the study’s protocol or as a substitute for a reported effect estimate. Without reported primary-outcome results, the observed effect underlying any illustration cannot be assessed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and identifies the Berg Balance Scale, change in physical activity level by questionnaires, and change in physical activity level among the secondary outcomes. It also states that the primary outcome has several categories or time points and is not reduced to one comparison. These details indicate that more than one outcome or measurement occasion is part of the record, but they do not reveal how the investigators prioritized analyses or managed the possibility of multiple comparisons.
Multiplicity matters because examining many outcomes or time points can increase the chance of obtaining a nominally unusual result even when no effect exists. Statistical plans can address this by defining a primary comparison in advance, controlling error across analyses, or interpreting secondary findings as exploratory. Which approach, if any, was specified for this trial is not reported in the registry record. No statistical analysis entries are listed, and numerical outcome results are not reported for the primary endpoint.
The primary-endpoint description gives analyzed completion counts of 13 for CogXergaming and 14 for Matter of Balance. The overall enrollment is 49. The record does not provide participant flow, reasons for non-completion or missing endpoint measurements, or an analysis population definition beyond saying that the endpoint data were analyzed for the participants who completed the study. It does not state whether analyses followed assignment regardless of adherence, whether participants were excluded for other reasons, or whether missing values were imputed.
These omissions limit assessment of possible attrition bias and of how fully the analysis preserved the randomized comparison. They also prevent comparison of the planned and analyzed populations. The registry record does not report a missing-data sensitivity analysis, a multiplicity adjustment, or a prespecified analysis plan; none should be inferred from the study design or completion status.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| CogXergaming | 0 | 22 | 0.0% |
| Matter of Balance Training | 0 | 23 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CogXergaming | 0 of 22 |
| Matter of Balance Training | 0 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CogXergaming | 0 of 22 |
| Matter of Balance Training | 0 of 23 |
The registry lists serious adverse events and other adverse events by group. For CogXergaming, 22 participants are listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For Matter of Balance Training, 23 participants are listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. No top serious-event terms are listed.
These figures describe what is recorded for the specified at-risk groups; they do not establish that no adverse experiences of any kind occurred. A zero count in a registry summary means that no events are reported in that category in the record, not that every possible event was actively ruled out or that all participants had identical experience. The record does not describe the event-collection process, observation window, severity criteria, or whether events were assessed for relationship to training.
The at-risk counts are not the same as the endpoint completion counts stated in the primary-outcome description, and the registry does not explain the difference. Safety counts should therefore be read in their own registry context rather than substituted for the analyzed outcome populations. These figures alone do not support a comparative safety estimate or a conclusion about the overall safety of either training approach.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, parallel-group comparison was conducted in frail older adults, with CogXergaming compared against Matter of Balance Training. It describes a primary functional measure, the 30-second Chair Stand Performance test, and says that higher repetition counts indicate better performance. It also gives the planned baseline and post-training assessment timing and reports the number of study completers whose primary-endpoint data were analyzed.
The record does not report numerical primary-outcome results. It therefore cannot show the average change in either arm, the difference between the arms, or the uncertainty around such a difference. It cannot establish whether an observed difference, if one existed, was large or small, precisely estimated or uncertain. Nor does the absence of numerical results establish that there was no difference.
The endpoint provides information about chair-rise performance as a measure of leg strength and endurance, but it is not a complete measure of every aim mentioned in the trial rationale. The study’s broader framing includes physical activity, cognitive function, community mobility, and quality of life. The listed primary measure cannot, by itself, answer questions about all of those outcomes. The registry lists secondary outcomes related to balance and physical activity, but their numerical results are not reported in the record.
The safety summary reports zero serious adverse events, zero other adverse events, and zero deaths in the at-risk groups listed. Those registry entries should be interpreted as reported event counts, not as proof that no adverse experiences occurred or that an intervention is safe for every person. Taken together, the available record describes the study question, design, endpoint, and event counts, but does not permit an estimate of comparative benefit or harm.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why design information and outcome estimates serve different purposes. The registry identifies randomized allocation, a parallel-group comparison, two behavioral interventions, and an objective functional endpoint. These details clarify what was intended to be compared and what the primary measurement represents. They do not, in the absence of numerical outcome results, quantify the comparison.
The endpoint timing is especially relevant to interpretation: the listed immediate post-training assessment was at Week 8 for group A and Week 10 for group B. A result based on change from baseline would need to be understood in relation to these different schedules. The registry record does not describe whether analysis adjusted for timing or other baseline characteristics, so no such method can be assumed.
The enrollment count and the endpoint completion counts also illustrate the importance of defining analysis populations. The record lists enrollment of 49, while its primary-outcome description identifies 13 and 14 completers with data analyzed. Without participant-flow details or reasons for missing data, readers cannot judge how the analyzed groups relate to all randomized participants or evaluate attrition-related concerns.
Finally, the record lists 28 outcome measures and multiple primary-outcome categories or time points, yet does not report a statistical analysis plan or outcome estimates. This makes transparent reporting of prespecified comparisons, missing-data handling, multiplicity, and uncertainty particularly important. The registry provides useful design context, but a statistical interpretation of effects requires results and analysis details that are not reported in the registry record.
14. 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 principal limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Group means, standard deviations, changes from baseline, between-group estimates, and uncertainty measures are absent from the information described. This prevents assessment of effect magnitude, precision, or direction.
The primary-outcome description states that 13 CogXergaming participants and 14 Matter of Balance participants completed the study and had their data analyzed. The registry lists enrollment of 49, but does not report participant flow, the number assigned to each arm, reasons participants did not complete the study, or reasons endpoint data were unavailable. The relation between the endpoint analysis population and the full enrolled population is therefore unclear.
The post-training endpoint assessment is scheduled at Week 8 for group A and Week 10 for group B. The record does not explain how these different assessment weeks were addressed analytically. It also does not report the statistical model, baseline-adjustment strategy, analysis population, or handling of missing observations. The record lists 28 outcome measures, but a multiplicity strategy and a detailed statistical analysis plan are not reported.
The intervention descriptions are incomplete in the registry record. The CogXergaming description ends mid-sentence after its session-duration information begins, and the Matter of Balance description gives a schedule but limited detail about training content. The record does not report adherence, intervention fidelity, or any adaptations. These limitations constrain interpretation of what participants received and how consistently it was delivered. They do not establish that these aspects were absent from the study; they are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults — NCT04534686.
- Registry record last updated 2025-08-28; status last verified 2025-08.
- Results first posted 2025-08-28.
- 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.
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18. Record Summary
NCT04534686 is a completed randomized, parallel-group study sponsored by the University of Illinois Chicago. It enrolled 49 participants and compared CogXergaming with Matter of Balance Training in frail older adults. Masking is listed as none, and phase is listed as NA.
The primary outcome was change in 30-second Chair Stand Performance, measured as repetitions at baseline and immediately after training. The registry lists post-training assessment at Week 8 for group A and Week 10 for group B, and says primary-outcome data were analyzed for 13 CogXergaming and 14 Matter of Balance completers. The listed secondary outcomes concern balance and physical activity; 28 outcome measures are recorded.
The registry reports zero serious adverse events, zero other adverse events, and zero deaths in the listed at-risk groups of 22 for CogXergaming and 23 for Matter of Balance Training. Numerical primary-outcome results, a between-group analysis, the statistical plan, and missing-data methods are not reported in the registry record.