Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline (NCT04009382), a randomized na study. The primary outcome is Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group trial sponsored by Massachusetts General Hospital. The study is marked completed, with enrollment of 124. The phase is listed as not applicable. The study start date is 2020-08-31 and the primary completion date is 2025-02-06. Those dates describe the record’s study timeline; they do not establish the timing of each participant’s follow-up.

Participants were assigned to Baduanjin or a Cognitive Fitness Program. Both intervention descriptions specify 24 weeks of participation, with a frequency of three times/week for the first three months and two times/week for the last three months. The registry does not report the allocation ratio, the method used to generate the random sequence, how allocation was concealed, or which parties were masked. It also does not explain how masking was maintained for exercise and cognitive-program interventions.

The primary outcome was the Alzheimer Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite, a continuous measure reported as a z score. Measurements were scheduled at baseline and 3, 6, and 9 months. The record identifies the change from baseline to month 6 as the primary timepoint, corresponding to the end of the stated intervention. The posted primary change data are described as available in 47 participants per group, while the group summaries list 47 for Baduanjin and 49 for the Cognitive Fitness Program. The record does not explain this difference in descriptions.

Secondary outcomes include participant-reported cognition, health-related outcomes, brain measures, blood markers, heart rate variability, anxiety, and cognitive tests. The registry lists 16 outcome measures overall and 14 secondary measures posted. A protocol-level statistical analysis plan, the planned analysis population, and the handling of repeated measurements 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

Analysis population for the primary outcome, as defined in the registry: post-treatment (month 6) - baseline, this data is only available in 47 participants per group.

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.

Population: individuals with subjective cognitive decline were enrolled in the study.

6. Primary Endpoint

The registry lists the primary outcome as Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite, measured over baseline, 3, 6, 9 months.

The primary endpoint is change from baseline to month 6 in the Alzheimer Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite, abbreviated ADCS-PACC. It combines validated neuropsychological tests selected for sensitivity to early changes between normal and subtly abnormal cognitive performance. The registry reports the composite as a z-transformed score. A score of 0 represents the reference population mean, and a change of 1.0 z-score unit corresponds to one standard deviation from that mean. Higher, more positive values indicate better performance; lower, more negative values indicate worse performance.

Expressing a composite as a z score places performance on a standardized scale. This is useful when the measure combines tests that may otherwise have different units, and it gives the change a meaning in relation to the reference population’s variability. The posted outcome is a change score, rather than a month-6 score alone, so it describes the difference between the month-6 assessment and baseline in each group. The registry identifies month 6 as the primary timepoint and the end of the intervention. Results at baseline, 3, and 9 months are part of the stated assessment schedule, but numerical results for those visits are not reported in the registry record in the registry record for this analysis.

The group mean changes were 0.352 for Baduanjin and 0.318 for the Cognitive Fitness Program. These are averages; they do not describe every participant’s individual trajectory. The registry record does not state a threshold for a clinically important difference on this composite, so the size of the observed mean contrast cannot by itself establish whether it represents a meaningful change for participants.

7. Results Posted in the Registry

• Cognitive Fitness Program: mean 0.32 versus 0.35 on control; difference -0.03 (95% CI -0.24 to 0.18), standardized effect d = -0.06; z-test p = 0.752.

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.

The Everyday Cognition - Participant Report Form (ECog) - Everyday Memory Domain

• 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:
  • Cognitive Fitness Program: mean -0.02 versus -0.02 on control; difference 0.00 (95% CI -0.23 to 0.24), standardized effect d = 0.00; z-test p = 0.986.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Fitness Program and the control. The interval gives the range of effects that remain compatible with the data.

Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)

• 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:
  • Cognitive Fitness Program: mean -0.94 versus -0.15 on control; difference -0.79 (95% CI -2.62 to 1.04), standardized effect d = -0.17; z-test p = 0.399.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Fitness Program and the control. The interval gives the range of effects that remain compatible with the data.

Blood Markers

• 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:
  • Cognitive Fitness Program: mean -2.40 versus -0.10 on control; difference -2.30 (95% CI -7.07 to 2.47), standardized effect d = -0.39; z-test p = 0.344.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Fitness Program and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary summaries span participant-reported everyday memory, health-related outcomes, and blood markers. Their numerical comparisons vary in direction and scale, and the blood-marker summary is based on fewer participants than the primary comparison. The registry lists 14 secondary outcome measures, but numerical group summaries for only some of those measures are included in the registry record for this analysis. The record therefore does not support a complete account of the pattern across every secondary measure.

These outcomes address different domains from the primary cognitive composite. Participant-reported measures reflect reported experience, while blood markers and other listed measures represent distinct biological or functional domains. Agreement or disagreement across such outcomes cannot be assumed to confirm or overturn the primary result. The primary endpoint remains the prespecified focus identified in the registry, and its posted contrast is near zero with a confidence interval that includes zero.

The secondary comparisons are unadjusted. When many outcomes are examined, some may appear more striking than others by chance, even if there is no systematic effect. Without information on prespecification, multiplicity control, or a hierarchy among secondary outcomes, isolated secondary p-values carry less weight than a clearly specified primary result. The registry record does not report a multiplicity procedure or a full set of sponsor-reported analyses.

Secondary outcomes may still help describe the range of measurements collected and support future questions. Their interpretation requires attention to the measure’s meaning, the number of participants contributing data, the uncertainty around each estimate, and whether the analyses were planned in advance. They should not be treated as independent confirmations merely because they address several domains, nor should a non-significant comparison be taken as evidence of no difference. The overall evidence remains limited by incomplete reporting of analysis methods and by the absence of numerical results for many listed secondary measures in the record used for this interpretation.

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

• The Everyday Cognition - Participant Report Form (ECog) - Everyday Memory Domain
• Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
• Brain Morphometry
• Blood Markers
• Heart Rate Variability
• Beck Anxiety Inventory (BAI)
• Symbol Digit Modalities Test (SDMT)
• The Stroop Color and Word Test (SCWT)

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference represent?

The outcome is continuous, so the group summaries are means with standard deviations. A mean is the average change across the participants included in that group’s summary. A standard deviation describes how dispersed individual changes are around that group mean; it is not the uncertainty in the mean itself. In this comparison, the group means are 0.352 for Baduanjin and 0.318 for the Cognitive Fitness Program, with standard deviations of 0.468 and 0.579, respectively.

The contrast is defined as Cognitive Fitness Program minus Baduanjin. This direction matters when interpreting its sign: a negative estimate means the Cognitive Fitness Program mean is numerically lower than the Baduanjin mean. The estimate is -0.034. Reversing the order of subtraction would reverse the sign, but not the substantive separation between the same group means. The contrast is unadjusted; it does not account for other variables or model the repeated outcome assessments.

What does a confidence interval communicate?

A confidence interval describes the range of values reasonably compatible with the data under the statistical method used. The 95% interval for the primary contrast is -0.244 to 0.176. Its inclusion of zero indicates that no difference is among the values compatible with the interval. The interval also includes negative and positive values, so it does not settle which group had the higher underlying mean change. The interval is not a range containing 95% of participants’ individual changes, nor does it assign a 95% probability to a particular fixed effect.

How should the p-value be read?

The unadjusted p-value is 0.752. In general, a p-value measures how surprising data at least as incompatible with a specified null hypothesis would be if that null hypothesis and the test assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the probability that chance alone produced the result. The p-value is unadjusted and should be interpreted alongside the effect estimate and its confidence interval, not as a stand-alone measure of importance.

What do standardized effects add?

The standardized mean difference listed for the primary outcome is -0.064. Standardizing expresses a mean contrast relative to a pooled measure of variation, so its scale is not the original z-score change scale. It can assist comparisons across continuous measures with different units, but it does not replace the original-scale estimate or confidence interval. A standardized effect is also sensitive to the amount of variation in the study groups. The registry does not report a threshold for a meaningful difference on either the original or standardized scale.

Why can variability matter?

General statistical explanation: greater variability among participant outcomes makes a group mean less precise when sample size is unchanged. Standard errors quantify uncertainty in estimated means or contrasts, whereas standard deviations describe spread among observations. The posted standard errors for the primary group means are 0.068 and 0.083. The contrast’s uncertainty is reflected more directly by its confidence interval. A calculation based on summary statistics may not capture features of a more elaborate model, such as correlations between repeated measurements or adjustment for baseline values.

What does randomization contribute?

Random assignment is intended to make the groups comparable, on average, with respect to measured and unmeasured characteristics at the point of assignment. It does not guarantee identical group characteristics in a particular trial, especially when the number of participants contributing to an outcome is limited. The registry record calls the study randomized and double-masked, but does not report the sequence-generation or concealment methods, the masking procedures, or the characteristics needed to assess baseline comparability.

The primary numerical contrast and p-value are unadjusted, summary-statistic comparisons. The registry record does not report a model specification, covariate adjustment, repeated-measures method, or a sponsor-reported analysis. The comparison therefore provides a useful description of the posted group summaries, but should not be assumed to reproduce an analysis plan that is not reported in the registry record.

11. Confidence Intervals and Precision

The primary estimate is -0.034, with a 95% confidence interval from -0.244 to 0.176. The interval extends on both sides of zero. This means the posted data are compatible with a range of possible group contrasts, including a modest negative contrast, no contrast, or a modest positive contrast under the stated subtraction order. The estimate alone should not be read as a precise determination of the difference between programs.

Precision concerns how narrowly the data locate an effect estimate. It is distinct from whether a result meets a significance threshold and from whether an effect is important to participants. Here, the interval crosses zero and the unadjusted p-value is 0.752. The data therefore do not clearly identify the direction of the contrast. No clinically important difference threshold is reported, so the interval cannot be classified against such a threshold using the registry record.

The available primary data are described as 47 participants per group, while the primary arm summaries list 47 and 49 participants. The record does not explain the difference between those counts. Nor does it report why data are unavailable for participants, whether the missingness differs by group, or how incomplete outcomes were handled. These details matter because an interval calculated from observed summaries describes uncertainty under its calculation assumptions, not necessarily uncertainty arising from all possible missing-data mechanisms.

The comparison is based on the posted mean and standard deviation summaries. No confidence limits are listed for the separate group means, and the registry record does not provide a full model-based analysis with adjustments or repeated-measures structure. The interval is informative about the unadjusted contrast, but its precision should not be treated as a complete account of every source of uncertainty in the trial.

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 illustrative sample sizes per arm for a future two-group comparison, not counts observed in this trial. The calculation uses the observed effect as its starting point, then considers planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. For each assumed effect, one column gives participants per arm for 80% power and another gives participants per arm for 90% power. These percentages describe the target probability of detecting the specified effect under the calculation’s assumptions if that effect were present; they do not describe the chance that the treatment is effective.

The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. For continuous outcomes such as the primary endpoint, the figures are participants per arm. The note about total numbers of events applies to time-to-event calculations, not these continuous-outcome figures.

For the primary endpoint, the planning illustration gives 3,797 participants per arm for 80% power and 5,083 participants per arm for 90% power when planning for 100% of the observed effect. Planning for 75% gives 6,750 and 9,037 participants per arm, respectively; planning for 50% gives 15,188 and 20,332 participants per arm, respectively. The pattern reflects a general statistical principle: smaller effects are harder to distinguish from random variation, so detecting a smaller effect generally requires more participants. The same logic applies to the secondary-outcome planning figures, though their effect estimates and variability differ.

These values are not observed power. They are planning illustrations derived from the observed effect under the stated assumptions. The trial’s own original sample-size assumptions and justification are not reported in the registry record, so the illustrations should not be interpreted as the trial’s prespecified enrollment target or as evidence about the design decision that produced enrollment of 124.

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 = -0.034; pooled standard deviation σ = 0.528.
2. n = 2 × (1.96 + 0.842)² × 0.528² / -0.034² = 3,796.8, rounded up to 3,797 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 <- -0.033919854                      # observed difference in means
sigma <- 0.527527873289684                     # 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(4009382)
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 = 3,797 (80% power), 5,083 (90% power)
 75% of observed effect: n per arm = 6,750 (80% power), 9,037 (90% power)
 50% of observed effect: n per arm = 15,188 (80% power), 20,332 (90% power)
power.t.test: 3797.8 
Simulated power at n = 3,797 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

The registry record lists 16 outcome measures, including the primary cognitive composite and secondary outcomes across several domains. It does not report how the study handled multiplicity: whether a particular hierarchy was used, whether secondary comparisons were adjusted, or whether any outcomes were designated exploratory. This matters because testing many outcomes can increase the chance that at least one result appears unusual even when the underlying differences are small. The posted secondary p-values should therefore be read as unadjusted comparisons rather than as confirmatory evidence across the full outcome set.

The record lists no reported analyses. It does not provide an analysis plan specifying the model for the repeated assessments at baseline and 3, 6, and 9 months, covariates, assumptions, or a strategy for testing group differences over time. The posted primary result concerns baseline-to-month-6 change, but the registry record does not say whether the analysis was intended to be a comparison of change scores, a baseline-adjusted endpoint analysis, or another model-based approach.

Missing-data methods and the analysis population are not reported in the registry record. The primary outcome description says the change data are available in 47 participants per group, while the group summaries list 47 participants for Baduanjin and 49 for the Cognitive Fitness Program. Reasons for missing observations, participant flow, and the relationship between the number randomized and the number analyzed are not reported. It is also not reported whether the analysis followed intention-to-treat principles, used a per-protocol population, or included another defined population.

These omissions limit assessment of whether the posted summaries represent all randomized participants and how sensitive the results might be to missing outcomes or analytic choices. They do not establish that a particular method was or was not used; they indicate that the method is not reported in the registry record. A more complete interpretation would require the prespecified statistical plan and detailed participant-level accounting, neither of which is reported in the registry record.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: gall bladder surgery (1.6%), broken shoulder (1.6%), covid hospitalization (1.6%), staph infection (1.6%), heart attack (1.6%).

The registry lists serious adverse events among 62 participants at risk in each group. Three serious adverse events affected participants in the Baduanjin group, and three affected participants in the Cognitive Fitness Program group. Other adverse events affected two participants in the Baduanjin group and one participant in the Cognitive Fitness Program group. Deaths are recorded as 0 in each group.

The serious-event terms listed include Gall bladder surgery, Broken shoulder, COVID hospitalization, Staph infection, Heart attack, and Skin Cancer, each reported as 1.6%. These terms describe events recorded in the registry; their listing does not establish that an intervention caused an event. The event percentages should be read in the context of the registry’s reported at-risk counts and its definitions, which are not further described in the registry record.

These figures are descriptive. They do not by themselves establish comparative safety, particularly without information about event timing, severity criteria, relatedness assessments, or statistical comparisons. The record does not report those details in the material available for this analysis.

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

The primary posted comparison describes a small average difference in change on the ADCS-PACC between the randomized groups at month 6. The Cognitive Fitness Program minus Baduanjin estimate is -0.034, and the 95% confidence interval ranges from -0.244 to 0.176. The interval includes zero, and the unadjusted p-value is 0.752. These results do not provide clear evidence of a group difference in the posted unadjusted comparison.

That interpretation is narrower than claiming the programs are the same. A non-significant comparison does not prove equivalence, and no equivalence margin or non-inferiority criterion is reported in the registry record. The interval leaves room for contrasts in either direction. The record also does not report a threshold for a clinically important difference, so statistical uncertainty cannot be translated into a conclusion about importance to participants.

The result concerns the measured change in a cognitive composite at the primary timepoint, among participants contributing to the posted summaries. It does not directly answer questions about every cognitive domain, long-term outcomes, other populations, or effects beyond the study’s stated follow-up schedule. Nor do the posted secondary summaries provide a basis for broad conclusions about all the study’s measured domains.

The randomized design is relevant because randomization is intended to support fair group comparisons. However, the registry record does not report important details of the allocation and analysis methods, the handling of missing data, or the analysis population. Those gaps constrain how fully the posted comparison can be interpreted. The reported adverse-event counts are also descriptive and do not establish whether events were caused by either intervention.

In practical statistical terms, the posted primary estimate is near zero but not highly precise enough to rule out all modest differences. The defensible conclusion is about what this estimate and interval show, not a claim that either program does or does not work. The record does not supply the additional design, analysis, or clinical-threshold information needed for stronger claims.

17. Why This Trial Matters Statistically

This trial is statistically informative because it places a standardized cognitive composite at the center of a randomized comparison and identifies a specific primary timepoint. The use of a change score at month 6 makes the target of the reported comparison explicit: average change from baseline at the end of the stated intervention, rather than an unspecified overall impression of cognitive performance.

The contrast also illustrates why estimates and uncertainty should be read together. The point estimate is -0.034, but its interval runs from -0.244 to 0.176. A small point estimate does not establish that all meaningful differences have been excluded, and a p-value of 0.752 does not establish that the groups are identical. The distinction between absence of clear evidence and evidence of equivalence is central to interpreting randomized trials.

The study also illustrates the limits of summary results. The primary change data are described as available in 47 participants per group, while the arm summaries list 47 and 49. The registry does not explain the difference, describe missing-data handling, or report the analysis population. Those omissions make participant accounting and analytic assumptions harder to evaluate.

Finally, the registry records a broad set of secondary measures. Such breadth can generate useful questions, but it also makes prespecification and multiplicity procedures important to interpretation. Since those methods are not reported, the secondary comparisons should be treated cautiously. Clearer reporting of analysis plans, missingness, and outcome-specific participant counts would make the statistical evidence easier to assess and reproduce.

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 main limitation for interpreting this trial is that the registry record contains limited detail about the statistical analysis. It reports no analyses, and does not describe the model used for repeated assessments, covariate adjustment, missing-data methods, or analysis population. The posted comparison is therefore best understood as an unadjusted summary-statistic contrast rather than as a documented complete trial analysis.

Participant counts are not entirely clear from the primary outcome description. The change data are described as available in 47 participants per group, whereas the posted summaries list 47 in Baduanjin and 49 in the Cognitive Fitness Program. The record does not explain this difference, give reasons for missing outcomes, or provide participant flow from enrollment through analysis. The secondary outcomes also have varying numbers of participants, including a smaller blood-marker sample, which makes their estimates differently precise.

The registry does not report the randomization procedure, allocation concealment, masking procedures, baseline characteristics, or intervention adherence. It gives the intervention schedule but not detailed program content or information about attendance. These are gaps in the registry record, not evidence that the trial lacked such procedures or information.

The record lists many outcome measures but does not state a multiplicity strategy or distinguish confirmatory from exploratory secondary analyses. It also does not report a clinically important difference threshold for the primary composite. Consequently, the clinical importance of the estimated contrast cannot be judged from the numerical result alone. Secondary numerical results are available for only some measures in the registry record used for this analysis, and the record does not provide enough information to assess the full outcome pattern or robustness across analytic choices.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline — NCT04009382.
• Registry record last updated 2026-11-06; status last verified 2026-11.
• Results first posted 2026-11-06.
• 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

NCT04009382 is a completed, randomized, double-masked, parallel-group study sponsored by Massachusetts General Hospital. It enrolled 124 participants and compared a 24-week Baduanjin exercise program with a 24-week Cognitive Fitness Program. The primary outcome was change from baseline to month 6 in the ADCS-PACC cognitive composite, reported as a z score.

The posted primary mean difference, Cognitive Fitness Program minus Baduanjin, was -0.034, with a 95% confidence interval from -0.244 to 0.176 and an unadjusted p-value of 0.752. The registry record does not report the full analysis plan, missing-data methods, analysis population, or multiplicity approach. The result should therefore be read as an unadjusted comparison of posted summaries, with uncertainty about both the contrast and some aspects of the analysis.