Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory (NCT03032796), a randomized na study. The primary outcome is mCPT (Derived From Test of Variables of Attention (T.O.V.A.)).

2. Clinical Question

The study’s central idea was to test whether cognitive and physical challenges might have a combined effect on cognitive control. A comparison of the combined-training group with a control can describe the difference between those groups, but does not by itself separate the contribution of physical training from cognitive training or demonstrate that their combination is synergistic. The registry lists Body Trainer and Brain Trainer as additional study groups, but the primary-outcome record says data were collected for only two groups; the posted primary summaries are for Body-Brain Trainer and the expectancy-matched control. The record does not report primary-outcome results for the component-training groups.

The primary measure was derived from the Test of Variables of Attention and recorded in milliseconds. The registry frames it as a measure of sustained attention and impulsivity. The clinical question is therefore about a measured cognitive performance outcome in healthy adults, not a clinical diagnosis or a patient health event. The posted group summaries and comparison describe the observed results for the two groups represented in the primary outcome record.

3. Trial Design

The registry describes a randomized, triple-masked, parallel behavioral study. It lists four interventions: Body-Brain Trainer, Body Trainer, Brain Trainer, and an expectancy-matched control. The study summary says participants were randomly assigned to one of four groups. The primary-outcome record, however, states that practical and funding considerations led to data collection for only two groups, and the posted primary summaries compare Body-Brain Trainer with the expectancy-matched control.

Body-Brain Trainer combined cognitive and physical challenges. The Body Trainer description says participants performed a basic reaction task while completing the physical aspects of the training. The Brain Trainer description says participants used the same platform while seated and playing with a controller, removing the physical-training aspect. The control group was described as using a battery of three laboratory apps intended not to have a significant impact on cognition. These descriptions explain the intended contrasts; they do not establish that all four groups contributed to the posted primary analysis.

The registry lists enrollment of 49, study start in 2017-01, primary completion in 2020-03, and status as completed. The study phase is listed as NA. The sponsor is the University of California, San Francisco. The posted primary outcome summary includes 24 participants in Body-Brain Trainer and 25 in the expectancy-matched control. The record does not report the original sample-size justification, the randomization procedure in detail, the masking procedures, or whether any interim analyses were planned or conducted.

The assessment was scheduled at baseline and following the intervention, with the latter measurement collected no more than one week after the intervention period ended, approximately nine weeks after baseline. The registry does not report enough detail to determine whether the posted arm means represent follow-up scores, changes from baseline, or another specific summary of the endpoint. Its outcome description calls the measure a change from baseline, so interpretation should retain that wording while recognizing that the posted results do not explain the calculation in further detail.

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.

Before assignment: We were only able to enroll in 2 of the 4 arms for this study due to resource limitations for this study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Due to logistical/practical consideration surrounding funding for this project, we were forced to only collect data for 2 gropus

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 mCPT (Derived From Test of Variables of Attention (T.O.V.A.)), measured over At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected).

The primary endpoint is mCPT, derived from the Test of Variables of Attention, and measured in milliseconds. The registry describes it as a change from baseline in sustained attention and impulsivity abilities. It specifies assessment at baseline and after the intervention, with the post-intervention assessment occurring no more than one week after the intervention ended and approximately nine weeks after baseline.

A continuous measure retains information about the magnitude of a measured response rather than reducing performance to a simple yes-or-no outcome. Reporting the mean gives a group-level summary, while the standard deviation describes how spread out individual observations are around that mean. These are general statistical interpretations of the reported summary measures; they do not explain the endpoint’s scoring rules or indicate how individual test performance should be understood clinically.

The endpoint is relevant to the study’s stated interest in cognitive control, sustained attention, and impulsivity. It offers a quantitative way to compare the recorded measure between the two groups with posted primary data. The registry does not report the test’s detailed scoring algorithm, a threshold for a meaningful difference, or a clinical interpretation of a given number of milliseconds. Nor does it specify in the posted result description whether the group summaries are raw follow-up values or calculated changes. The primary result should therefore be read as a comparison of the posted continuous summaries, not as evidence of a clinical benefit or a diagnosis.

7. Results Posted in the Registry

• BBT: Body-Brain Trainer: mean 72.50 versus 52.20 on control; difference 20.30 (95% CI 0.25 to 40.35), standardized effect d = 0.57; z-test p = 0.047.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Body-Brain Trainer: mean 29.70 versus 24.10 on control; difference 5.60 (95% CI -1.27 to 12.47), standardized effect d = 0.46; z-test p = 0.110.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Body-Brain Trainer and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts one secondary outcome: response-time variability on a delayed recognition working-memory task, assessed at baseline and after the intervention. Its posted comparison is between Body-Brain Trainer and the expectancy-matched control. The numerical summary and interval are reported with that outcome, and its unadjusted p-value is 0.11. The interval includes zero, so the secondary result does not provide a clear separation between the groups under that interval summary.

At a broad level, the secondary result does not offer the same statistical signal as the primary comparison. That contrast should not be treated as a contradiction: the outcomes measure different aspects of cognitive performance, and the registry does not report that they were expected to move together or that one is a validation of the other. The secondary finding neither confirms nor rules out the primary result, and it does not answer the study’s synergy question.

Unadjusted secondary results generally carry less weight when multiple outcomes are examined. As a general statistical matter, considering more outcomes creates more opportunities to observe a result that appears notable even when there is no underlying effect. Methods such as prespecified outcome hierarchies or multiplicity adjustments can address that issue, but the registry does not report such a plan or adjustment. The secondary result should therefore be considered exploratory rather than treated as independent confirmation of the primary finding.

The record lists six outcome measures, but only one secondary outcome is posted in the secondary results. It reports no secondary analyses. That means the available secondary information is limited, and the registry record does not permit a full assessment of the set of outcomes considered or the relationship between planned and reported analyses. It is not reported in the registry record whether the posted secondary measure was designated in advance as confirmatory, whether additional outcomes were analyzed but not posted, or how missing measurements were handled.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline

9. Statistical Interpretation

10. Statistical Methods Explained

The result is a comparison of group means on a continuous measure. A mean is the arithmetic average of the recorded values in a group. In this case the outcome is recorded in milliseconds, so the reported means and their difference are also expressed in milliseconds. The registry lists standard deviations as the dispersion measure. In general, a standard deviation describes how variable individual observations are around their group mean; it is not the uncertainty around the estimated mean difference and should not be read as a confidence interval.

What does the mean difference describe?

The reported mean difference is 20.3 milliseconds, with the Body-Brain Trainer group mean higher than the control group mean. It expresses the contrast between the posted group summaries on the measured endpoint. It is not a percentage change, a ratio, or a measure of how many individual participants improved. The registry does not give individual-level observations, so the group summaries cannot show the distribution of individual changes or whether the same pattern occurred for most participants.

The endpoint description refers to change from baseline, and the outcome timing includes baseline and a later assessment. However, the registry does not explain precisely how the posted arm means were formed. In particular, the record does not say whether those means are group mean changes, follow-up means, or another summary. That distinction matters because a comparison of changes and a comparison of follow-up values can answer different statistical questions. The posted summary should not be assigned a more detailed interpretation than the record supports.

How should the interval be understood?

A confidence interval is a general statistical way to express uncertainty around an estimate. Under its stated method and assumptions, it gives a range of values compatible with the observed data. The primary interval runs from a lower limit close to zero to 40.35 milliseconds. Its breadth means the estimated contrast is not highly precise: values near no difference and more substantial positive differences are both compatible with the interval. The registry does not report the interval’s confidence level or provide details of the method used to calculate it, so the interval’s level and construction are not reported in the registry record.

An interval is not a range containing a known proportion of individual participant outcomes, and its endpoints are not a guarantee of the true effect. It is also not a substitute for assessing design limitations, analysis choices, or the meaning of the endpoint. Here, the proximity of the lower limit to zero is important when considering the estimate alongside the p-value. It does not erase the observed contrast, but it indicates that the data do not pin down its size closely.

What does the p-value tell us?

The reported primary p-value is 0.047 and is described as unadjusted. In general, a p-value measures how compatible the observed data, or data more extreme, are with a null model under specified assumptions. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or the probability that an intervention is effective. Its interpretation depends on the statistical model and analysis choices. Those details are not reported in the registry record.

The p-value and interval are complementary rather than interchangeable. A p-value provides a summary relative to a null hypothesis; an interval gives a range of plausible values under a particular interval procedure. Neither says whether the observed contrast is practically important. The record does not identify a meaningful-difference threshold for the mCPT measure. The p-value is unadjusted, and the record does not state whether other outcomes or comparisons were included in a broader multiplicity plan.

Why do group sizes and variation matter?

The posted primary summaries include 24 participants in Body-Brain Trainer and 25 in the expectancy-matched control. The reported standard deviations are 39.7 and 31.2 milliseconds. In general, uncertainty in a mean comparison is influenced by both the amount of data and the variation in the measurements. More variable observations can make an estimated group contrast less precise, while more observations can generally improve precision, all else being equal. These are general statistical principles, not claims about an unreported design calculation for this trial.

The registry identifies the study as randomized, which in general is intended to support fair comparison by assigning participants to groups using chance. Randomization does not guarantee that every observed characteristic is balanced in a particular study, nor does it resolve incomplete outcome collection or analysis choices. The randomization sequence, allocation concealment, baseline balance, analysis population, and handling of missing data are not reported in the registry record. No adjusted estimate is posted, and the record does not state whether baseline values were included in a model.

Why can over-dispersion matter?

General note: over-dispersion refers to observed variation greater than a statistical model expects. When a model underestimates the variability in the data, its standard errors can be too small and its intervals too narrow, creating more apparent precision than is warranted. The posted endpoint is continuous and is summarized with means and standard deviations; the registry does not report an over-dispersion assessment or a model that would allow a specific over-dispersion concern to be evaluated. This concept is therefore relevant as a general modeling issue, not as a finding about this trial.

More generally, the assumptions behind a mean comparison include an appropriate representation of the outcome and its variability. The registry does not report the detailed model, diagnostics, transformations, covariates, or robustness checks. Without those details, the numerical summaries can be described, but the adequacy of a particular inferential model cannot be independently assessed from the registry record alone.

11. Confidence Intervals and Precision

The primary mean difference is 20.3 milliseconds, with a reported interval extending from a lower limit close to zero to 40.35 milliseconds. That range is wide enough to include a result very near no difference as well as larger positive differences. It therefore supports a cautious reading of the estimated size: the observed direction is clear from the group means, but the exact magnitude is uncertain.

The interval communicates uncertainty about the group contrast, not the spread of individual measurements. The standard deviations of 39.7 milliseconds for Body-Brain Trainer and 31.2 milliseconds for control describe variation within the groups. Those values are separate from the interval around the mean difference. The registry does not report an interval level or calculation method, so those details are not reported in the registry record.

The reported unadjusted p-value of 0.047 is close to a commonly used significance boundary, but a threshold-based reading alone would obscure the interval’s width and the study’s design limits. The p-value does not show that the effect estimate is precise, nor does it indicate the probability that the result is true. The interval and p-value address different aspects of uncertainty and should be considered with the group summaries and the limited primary-outcome coverage.

Precision is also limited by the fact that only two groups have posted primary results. The registry does not report the outcome summaries for the Body Trainer and Brain Trainer groups, so the uncertainty around the primary comparison cannot answer the separate question of synergy. A more precise estimate of the same two-group contrast would not, by itself, resolve that design question. The record also does not report a threshold for a meaningful difference in the mCPT measure, so statistical uncertainty cannot be translated into a judgment about practical importance.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm because the outcomes in this study are continuous. They are not total-event counts. The registry’s planning illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers effects equal to the observed effect and fractions of that effect. The original trial’s own design assumptions and sample-size justification are not reported in the registry record.

For the primary comparison, planning for 100% of the observed effect gives 49 participants per arm for 80% power and 65 participants per arm for 90% power. Planning for 75% of the observed effect gives 86 participants per arm for 80% power and 115 participants per arm for 90% power. Planning for 50% of the observed effect gives 194 participants per arm for 80% power and 259 participants per arm for 90% power. These are hypothetical planning illustrations based on the observed estimate, not the study’s original recruitment target.

In plain terms, 80% power describes a design that would detect the specified effect in 80% of repeated studies under the assumptions used, if that effect were present. The 90% column describes the corresponding design goal for detecting the specified effect in 90% of repeated studies. Greater power requires more participants when other assumptions are held constant. The illustration also shows that planning for a smaller effect requires more participants per arm than planning for the full observed effect.

The same general reading applies to the secondary-outcome planning figures, which use that outcome’s observed effect. These figures are not observed power, and they do not show the probability that the trial’s result is correct. Because the illustration uses observed effects, its projected requirements depend on estimates from this small study and should not be mistaken for independently established design targets.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 20.300; pooled standard deviation σ = 35.614.
2. n = 2 × (1.96 + 0.842)² × 35.614² / 20.300² = 48.3, rounded up to 49 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 20.3                      # observed difference in means
sigma <- 35.6139555481729                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3032796)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 49 (80% power), 65 (90% power)
 75% of observed effect: n per arm = 86 (80% power), 115 (90% power)
 50% of observed effect: n per arm = 194 (80% power), 259 (90% power)
power.t.test: 49.3 
Simulated power at n = 49 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study considers several outcomes, comparisons, time points, or analyses. In general, the more statistical tests that are conducted, the greater the chance that at least one will appear unusual under a no-effect model. Prespecified analysis plans and adjustments can help make the interpretation of multiple results more disciplined. The registry lists six outcome measures, posts one secondary outcome, and reports no secondary analyses. It does not describe a multiplicity strategy for the primary and secondary outcomes, so whether the unadjusted p-values were part of a broader testing plan is not reported in the registry record.

The primary p-value is explicitly unadjusted. This means it is presented without a reported adjustment for multiple comparisons; it does not establish whether other analyses were conducted. The registry does not report a prespecified hierarchy of outcomes, a family of hypotheses, or a correction procedure. The secondary result should be read with particular caution because its status relative to other outcomes and analyses is unclear. The absence of a reported plan is not evidence that no plan existed, but the plan is not reported in the registry record.

Missing-data handling is also not described. The primary summaries include 24 participants in Body-Brain Trainer and 25 in the expectancy-matched control, and the secondary comparison has the same group counts. These posted counts describe the summarized outcome data, but they do not reveal whether all randomized participants contributed observations, why any data might be absent, or how incomplete records were treated. The registry does not report imputation, exclusion rules, sensitivity analyses, or a comparison of participants with and without outcome data.

The analysis population is not reported in the registry record. In particular, it is not stated whether the results use an intention-to-treat population, a per-protocol population, or another defined set of participants. Nor does the record explain whether participants were analyzed according to their randomized group or how adherence to the behavioral interventions was incorporated. These details matter because analysis choices can influence the meaning of a randomized comparison, especially when outcomes or participation are incomplete.

Finally, the primary endpoint is described as a change from baseline, but the registry does not explain the calculation used for the reported group summaries or whether baseline values were included in an adjusted analysis. The modeling approach, covariates, and checks of assumptions are not reported in the registry record. These gaps limit independent evaluation of the analysis and counsel against treating a single unadjusted p-value as a complete account of the evidence.

15. 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 5% reporting threshold.

The registry lists zero serious adverse events and zero other adverse events in the Body-Brain Trainer group, with 24 participants at risk for each category. It also lists zero serious adverse events and zero other adverse events in the expectancy-matched control, with 25 participants at risk for each category. Deaths are listed as zero in both groups. The Body Trainer and Brain Trainer groups have no participants at risk listed in the adverse-event record.

These figures describe what the registry reports for the groups with posted safety denominators. They should not be read as proof that no adverse events occurred outside the recorded categories or observation period. The registry does not describe how adverse events were collected, the duration of safety monitoring, or the criteria used to classify events. Because the other two groups have no participants at risk listed, the record does not support safety comparisons involving those groups. The absence of reported events in the represented groups does not establish that an intervention is risk-free.

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

The posted primary results show a higher reported mean mCPT value in the Body-Brain Trainer group than in the expectancy-matched control group, with a mean difference of 20.3 milliseconds. The reported interval reaches from a lower limit close to zero to 40.35 milliseconds, and the unadjusted p-value is 0.047. Together, these statistics describe a group contrast with uncertainty about its size. The registry does not report a threshold for a meaningful difference on this measure, so the statistics alone do not establish practical or clinical importance.

The comparison does not show that a treatment works or does not work. It describes posted results for a specific behavioral intervention, outcome measure, and study population. The record concerns healthy adults and a short assessment period after the intervention. It does not establish effects in people with a clinical condition, at later time points, or on outcomes beyond those reported. The registry’s outcome description refers to change from baseline, but the exact derivation of the posted arm summaries is not reported.

The study’s stated interest in synergy requires particular care in interpretation. Body-Brain Trainer combines cognitive and physical challenges, but the primary result record contains only the combined-training group and the expectancy-matched control. The posted comparison therefore cannot isolate the contribution of either component, or determine whether the combination produces more than would be expected from the components separately. The additional component-training groups are described in the registry, but primary-outcome data for them are not posted.

The record does not report analysis details that would clarify adjustment for baseline, missing data, multiplicity, or the analysis population. The unadjusted result should be considered with those limitations rather than as a standalone verdict. The interval’s lower limit being close to zero also makes the estimated magnitude uncertain. A result near a conventional p-value threshold is not a substitute for a clear estimate of precision, evidence about clinical importance, or a complete account of all planned comparisons.

Overall, the posted data describe a difference between the two represented groups on the primary measure, with uncertainty around its size. They do not establish synergy, explain the mechanism behind the contrast, or provide a basis for medical advice. Those conclusions would require evidence and analysis not reported in the registry record.

17. Why This Trial Matters Statistically

This trial raises an important design question: when an intervention combines physical and cognitive challenges, how can a study distinguish a combined effect from the contribution of each component? A multi-group design that includes the combined intervention, the component interventions, and an appropriate control can address that question more directly than a two-group comparison. The registry describes all four groups, but the primary results cover only Body-Brain Trainer and the expectancy-matched control. That gap illustrates why the availability of the component-group outcome data matters when the stated scientific goal is synergy.

The trial also shows why effect estimates, uncertainty intervals, and p-values should be interpreted together. The estimated mean difference gives the observed contrast, while the interval indicates that its magnitude remains uncertain. The unadjusted p-value is one summary relative to a null model, not a measure of importance or a standalone proof. Considering these measures together helps prevent a threshold-focused reading from obscuring the limited precision and the incomplete primary-outcome coverage.

Planning illustrations based on observed effects can help readers understand how sample-size needs change with the effect targeted. They are not substitutes for the original design justification, which is not reported in the registry record. The primary illustration shows that planning for smaller fractions of the observed effect requires more participants per arm under the stated assumptions. Because the observed estimate itself is uncertain, planning based on it should be treated as illustrative rather than definitive.

Finally, registry results are most informative when the relationship between planned outcomes, analysis populations, missing-data handling, and reported analyses is clear. Those details are not reported. Their absence limits what can be concluded from otherwise interpretable group summaries. This case highlights that transparent reporting is part of statistical evidence: readers need both numerical results and the analysis context required to judge how robustly those results answer the scientific question.

18. 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 trial-specific limitation is that the primary-outcome record says data were collected for only two groups for logistical and practical reasons related to funding. The study’s stated goal concerned possible synergy, but the posted primary summaries compare only Body-Brain Trainer with the expectancy-matched control. Without posted primary results for Body Trainer and Brain Trainer, the separate contributions of physical and cognitive training cannot be evaluated from these results.

The registry does not report the original sample-size calculation or its assumptions. The sample-size figures associated with the observed comparison are planning illustrations, not evidence that the trial was designed around those requirements. The posted primary group summaries include 24 and 25 participants, and the resulting interval extends from close to zero to a larger positive difference. The estimate’s precision is therefore limited, and the registry does not report a threshold for an important difference on the endpoint.

There is also ambiguity in the outcome summary. The endpoint is described as change from baseline and measured at baseline and after intervention, but the record does not explain whether the posted arm means are changes, follow-up values, or another summary. It does not report a baseline-adjusted analysis, the statistical model, the analysis population, missing-data methods, or sensitivity analyses. These omissions limit independent assessment of the comparison.

Multiplicity is another uncertainty. The registry lists six outcome measures, posts one secondary outcome, and does not describe a plan for controlling or interpreting multiple analyses. The primary p-value is unadjusted, and reported secondary analyses are absent. The record does not make clear which outcomes and comparisons were prespecified or how any unreported measures were handled. Finally, the results concern healthy adults and the assessment period described in the registry; broader populations and longer-term outcomes are not addressed by the posted summaries.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory — NCT03032796.
• Registry record last updated 2025-09-15; status last verified 2025-09.
• Results first posted 2025-09-15.
• 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.

22. Record Summary

The registry describes a completed randomized, triple-masked, parallel behavioral study of Body-Brain Trainer and related training conditions in healthy adults. It lists enrollment of 49 and a study period from 2017-01 to primary completion in 2020-03. The primary endpoint is an mCPT measure derived from the Test of Variables of Attention, recorded in milliseconds and described as a change from baseline in sustained attention and impulsivity.

Primary-outcome summaries are posted for Body-Brain Trainer and an expectancy-matched control only. The reported mean difference is 20.3 milliseconds, with an unadjusted p-value of 0.047 and an interval whose lower limit is close to zero. One secondary outcome is posted, and the registry reports no secondary analyses. The record does not report the original sample-size justification, analysis population, missing-data approach, multiplicity plan, or detailed model. Because results for the component-training groups are not posted for the primary outcome, the available comparison does not establish whether the combined training has a synergistic effect.