BAILA: Being Active, Increasing Latinos Healthy Aging: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for BAILA: Being Active, Increasing Latinos Healthy Aging (NCT01988233), a randomized na study. The primary outcome is Minutes Per Week of Moderate to Vigorous Physical Activity.

2. Clinical Question

3. Trial Design

BAILA was a randomized, parallel-group trial with no masking listed in the registry. The registry describes two behavioral groups: the BAILAMOS© Dance Program and the Health Education Control Group. Enrollment was 333. The posted randomized group counts were 167 for BAILAMOS© and 166 for health education. The trial status is completed; the recorded start was 2013-03 and primary completion was 2017-06. The phase is listed as NA.

The intervention description specifies a twice-weekly adoption phase lasting 4 months and a twice-weekly maintenance phase lasting 4 months. A professional dance instructor introduced a new dance style during each month of adoption. The maintenance description refers to an indigenous dance leader, but the record text ends before completing the details. The health education classes were described as Spanish-language classes for older adults, conducted by extension staff. Their full description is also incomplete.

The stated purpose was to test the revised BAILAMOS© program in relation to lifestyle physical activity and health outcomes, including physical and cognitive function, self-reported functional limitations, and disability. The posted primary measure is weekly moderate-to-vigorous physical activity. Three secondary outcomes are posted: 400 meter walk time, cognitive function, and self-reported functional limitations. No statistical analysis entries are listed in the registry record. Details of the trial's original allocation procedure, recruitment process, follow-up schedule beyond the endpoint timeframes, and original design assumptions 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Those randomized to intervention or control 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: 333 participants were randomized.

6. Primary Endpoint

The registry lists the primary outcome as Minutes Per Week of Moderate to Vigorous Physical Activity, measured over Change from baseline to post-intervention 4 months.

The primary endpoint is change in minutes per week of moderate-to-vigorous physical activity from baseline to post-intervention 4 months. The measure is based on the CHAMPS PA Questionnaire, which assesses the reported weekly frequency and duration of lifestyle physical activities meaningful and appropriate for older adults. A change score expresses how the measured activity level at the post-intervention assessment differs from baseline for each participant, and the posted group summaries are means of those changes.

This type of endpoint is used to represent activity behavior over a period rather than performance on a single laboratory task. The questionnaire includes a range of lifestyle activities, making it relevant to the trial's focus on physical activity in older adults. It is self-reported, however, so the endpoint reflects questionnaire responses rather than direct measurement of movement. The registry does not report details such as the questionnaire scoring rules, how incomplete responses were handled, or whether assessors were masked.

The primary result compares the mean change in the dance group with the mean change in the health education group. A mean difference describes the distance between those group averages in the endpoint's units. It does not, by itself, describe how much individual participants varied, whether the difference is important to participants, or whether it persisted beyond the 4-month assessment.

7. Results Posted in the Registry

• BAILAMOS© Dance Program: mean 156.84 versus 86.84 on control; difference 70.00 (95% CI 63.06 to 76.94), standardized effect d = 2.17; z-test p = <0.001.

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.

Physical Function Performance as Assessed by Time of 400 Meter Walk

• 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:
  • BAILAMOS© Dance Program: mean -0.31 versus 2.48 on control; difference -2.79 (95% CI -5.38 to -0.20), standardized effect d = -0.24; z-test p = 0.035.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for BAILAMOS© Dance Program than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Cognitive Function

• 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:
  • BAILAMOS© Dance Program: mean 0.25 versus 0.03 on control; difference 0.22 (95% CI -0.09 to 0.53), standardized effect d = 0.15; z-test p = 0.162.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BAILAMOS© Dance Program and the control. The interval gives the range of effects that remain compatible with the data.

Self-Reported Functional Limitations

• 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:
  • BAILAMOS© Dance Program: mean -0.51 versus 0.23 on control; difference -0.74 (95% CI -2.60 to 1.12), standardized effect d = -0.09; z-test p = 0.436.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BAILAMOS© Dance Program and the control. The interval gives the range of effects that remain compatible with the data.

The secondary results cover physical function performance assessed by 400 meter walk time, cognitive function, and self-reported functional limitations. Taken together, the posted estimates do not form a uniformly precise pattern: the physical function comparison has an interval that excludes zero, while the cognitive function and self-reported limitations intervals include zero. These are unadjusted comparisons, and the registry does not list an analysis plan or an account of how the investigators intended to interpret this family of outcomes.

The secondary measures address related but distinct aspects of function and health. They are not alternative measurements of the primary physical-activity endpoint. A difference in reported activity need not be accompanied by a clearly estimated difference in every functional outcome, particularly when the measures capture different constructs and may have different variability. Conversely, a secondary finding does not establish the mechanism behind the primary result.

Unadjusted testing across multiple outcomes can increase the chance of at least one apparently notable result arising by chance when there is no corresponding effect. Whether an adjustment or hierarchy was planned is not reported in the registry record. For that reason, the secondary comparisons should be treated as supportive or exploratory evidence rather than as stand-alone confirmation. The posted pattern can motivate further evaluation, but does not establish that the outcomes were prespecified in a particular order or that a multiplicity correction was unnecessary.

The number of participants contributing to each posted endpoint also varies. The registry does not explain the differences or state how incomplete measurements were handled. Such differences can affect both precision and comparability across outcomes. The overall secondary pattern should therefore be considered alongside the primary result, the uncertainty intervals, and the limited information about analysis and missing-data procedures, rather than as a single combined claim about broad health effects.

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

• Physical Function Performance as Assessed by Time of 400 Meter Walk
• Cognitive Function
• Self-Reported Functional Limitations

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a change measured in minutes per week, and the registry reports group means and standard deviations. A mean summarizes the center of a set of values. A standard deviation summarizes how dispersed those values are around the mean. These answer different questions: a mean describes the average change, while a standard deviation describes participant-to-participant variation. Neither statistic alone gives the full distribution of responses.

What does a mean difference describe?

A mean difference compares the average outcome in one group with the average outcome in another. For the primary outcome, the posted difference is 70.0 minutes/week, with the BAILAMOS© mean change of 156.8 and the health education mean change of 86.84. Its unit remains minutes per week because it is a contrast between group means on that scale. This is not a percentage change, a ratio, or an estimate of an individual participant's change.

Random assignment is intended to make the groups comparable on average at the start of a trial, including on characteristics that were not measured. The registry identifies the trial as randomized and parallel-group, but it does not report the random sequence method, concealment procedures, or whether the analysis followed the original assignments regardless of attendance. Those details matter when assessing the protection randomization offers in practice.

How should the p-value be read?

A p-value evaluates how compatible the observed result is with a specified null model, commonly one in which the groups have no difference, assuming the analysis assumptions hold. It is not the probability that the null hypothesis is true, and it is not a measure of the size or practical importance of a result. The registry reports an unadjusted p < 0.001 for the primary comparison. The analysis model and its assumptions are not described in the registry record, so the p-value should be interpreted as the posted unadjusted result rather than as a complete model specification.

Unadjusted means that the reported comparison is not described as adjusted for other variables or for testing multiple outcomes. The term does not tell the reader whether the investigators performed other analyses that are not listed. The registry has no analysis entries, so the investigator analysis plan, including any covariate adjustment or sensitivity analysis, is not reported in the registry record.

What does an interval add?

An interval around an estimate communicates its statistical precision: it gives a range of values compatible with the data under the method used to construct it. The primary comparison has posted limits of 63.06 and 76.94. The confidence level and calculation method are not stated in the registry record. General interpretation of a confidence interval depends on the sampling and modeling assumptions, which cannot be fully checked from these summary results alone.

Interval width is influenced by the amount of information in the data and by their variability. More observations can improve precision when other conditions are comparable; high variability can reduce it. The reported group standard deviations are different, so a method that handles group variability appropriately is relevant. Whether the trial's analysis used a pooled-variance method, a method allowing unequal variances, or another model is not reported in the registry record. The comparison statistics include a pooled standard deviation, but that alone does not establish the investigator's analysis method.

Why does variability matter?

When observations vary more than a simple model expects, uncertainty estimates based on an overly restrictive model can be misleading. General statistical methods can account for unequal spreads, repeated measurements, clustering, or over-dispersion when those features are present. Over-dispersion means that the observed variation exceeds what a chosen model expects. It is a general issue in statistical analysis, not a feature that can be established from the registry summary alone. The record does not state whether clustering or over-dispersion was relevant to this trial or how either was handled.

Standardized effect measures express a mean contrast relative to a measure of spread, which can help compare scales but does not replace the original units. A standardized effect is dependent on the chosen variability measure. The registry posts a standardized comparison value, but the practical meaning of the primary endpoint is more directly conveyed by its minutes-per-week scale. No threshold for a clinically important change is reported.

What do the planning figures represent?

The sample-size planning illustrations use the observed effect as a reference and consider detecting stated fractions of that effect. They assume a two-sided significance level of 0.05, equal allocation between the two groups, and a normal approximation. For these continuous outcomes, the figures refer to participants per arm. The planning calculations are not the trial's original sample-size justification; the original design assumptions are not reported in the registry record.

In general, power is the probability that a specified analysis would detect an effect of a specified size under its assumptions. The 80% and 90% columns give planning counts associated with those target probabilities for the effect size used in each scenario. They are not evidence about the probability that the completed trial found a true effect. Smaller target effects require more participants to detect under otherwise comparable assumptions. The displayed planning counts are illustrations, not observed power.

The registry does not report whether the outcome analysis used all randomized participants, how it treated incomplete questionnaires, or whether it made adjustments for multiple endpoints. General explanations of means, intervals, p-values, and planning power can clarify statistical concepts, but they cannot fill those gaps in the trial-specific methods.

11. Confidence Intervals and Precision

The primary mean difference is 70.0 minutes/week, and the interval posted for that estimate runs from 63.06 to 76.94. The limits describe statistical uncertainty around the estimated contrast under the method used to calculate them. Both limits are above zero, while the reported unadjusted p-value is p < 0.001. The confidence level and calculation method for the interval are not reported in the registry record, so its coverage level should not be assumed.

Precision is distinct from importance. A relatively narrow interval can indicate that an estimate is located within a more limited range, but it does not establish whether a difference matters to participants or clinicians. The registry does not give a threshold for a meaningful change in weekly physical activity. The estimate also concerns a group average; individual participants may have had changes that differed substantially from that average.

The group standard deviations are 12.57 and 43.9. These describe the spread of participant outcomes within each group, not the precision of the mean difference. The registry does not explain why the spreads differ or identify the analysis method used to construct the interval. The pooled standard deviation reported with the comparison is a summary statistic, but it does not identify the trial's full statistical model.

For secondary outcomes, the posted intervals vary in relation to zero, and their estimates are less precise in some cases than others. Their interpretation also depends on multiple testing and the analysis plan, neither of which is detailed in the registry record. Across outcomes, intervals are more informative than a binary reading of whether a p-value crosses a threshold because they retain information about the range and scale of plausible estimates. Even so, an interval cannot address unreported design or data-handling decisions.

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 sample-size planning figures are for participants per arm, not total events. The record states that the calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is a stated fraction of the observed effect. The original trial design assumptions and the trial's own sample-size justification are not reported in the registry record.

The 80% power column gives an illustrative number of participants per arm for a design intended to have an 80% probability of detecting the effect used in that scenario, if the assumptions hold. The 90% column applies the same idea to a 90% target probability. Power is tied to a particular assumed effect, variability, analysis, and significance threshold; it is not a general property of the enrolled sample. The figures therefore help compare planning scenarios, not establish what the completed trial was capable of detecting in every circumstance.

The rows use 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. These are planning illustrations anchored to the observed estimate, not effects known in advance to be true. Smaller effects generally require more participants to detect than larger effects under otherwise similar assumptions. The illustrations also rely on equal allocation, even though the randomized group counts are not identical.

These calculated sample sizes are planning illustrations, not observed power. They do not show the probability that the trial's result is true, and they should not be used as a post hoc verdict on whether a result is valid. The original justification, any allowance for incomplete outcomes, and any changes to the planned enrollment are not reported in the registry record.

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 = 70.000; pooled standard deviation σ = 32.248.
2. n = 2 × (1.96 + 0.842)² × 32.248² / 70.000² = 3.3, rounded up to 4 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 <- 70                      # observed difference in means
sigma <- 32.2480221834332                     # 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(1988233)
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 = 4 (80% power), 5 (90% power)
 75% of observed effect: n per arm = 6 (80% power), 8 (90% power)
 50% of observed effect: n per arm = 14 (80% power), 18 (90% power)
power.t.test: 4.5 
Simulated power at n = 4 per arm: 0.724 (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 posts a primary endpoint and three secondary outcomes, but it does not report a multiplicity strategy. It is therefore not possible to tell whether the trial planned a hierarchy of outcomes, a family-wise error adjustment, a false-discovery procedure, or another approach to interpreting multiple statistical tests. The p-values listed for comparisons are unadjusted. When multiple outcomes are tested, the chance of at least one result appearing noteworthy can increase; this is a general statistical concern, not proof that any particular posted result is false.

No statistical analysis entries are listed in the registry record. The record does not describe the model for the primary or secondary comparisons, the use of covariates, baseline adjustment, repeated-measures methods, subgroup analyses, or sensitivity analyses. It also does not report whether the investigators followed a prespecified analysis plan or whether any analyses changed after data collection.

The registry lists randomized counts of 167 and 166. The primary endpoint has the same group counts. The 400 meter walk outcome has group counts of 151 and 149; cognitive function has 167 and 166; self-reported functional limitations has 165 and 166. These are endpoint-specific counts, not an explanation of why measurements differ. The registry does not report whether the differences reflect unavailable assessments, exclusions, or another reason.

Missing-data methods are not reported in the registry record. It is not stated whether missing outcomes were imputed, whether complete cases were analyzed, or whether sensitivity analyses assessed departures from assumptions about missingness. The analysis population is also not identified: the record does not say whether the comparisons followed an intention-to-treat principle, a per-protocol definition, or another population rule. Without these details, the effect of missing data and analytic exclusions cannot be evaluated from the posted summaries alone.

These omissions do not establish that the trial lacked a statistical plan or did not address missingness. They mean only that the registry record does not provide those details, limiting independent assessment of how the posted estimates were obtained.

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.

The registry lists 167 participants at risk for serious adverse events in the BAILAMOS© Dance Program group and 166 in the Health Education Control Group. It reports zero participants affected by serious adverse events in either group. The other adverse event counts are also listed as zero in both groups, and deaths are listed as zero in both groups. No serious adverse event terms are listed.

These figures describe the adverse-event entries in the registry record and the stated numbers at risk. They do not show that the probability of an event is zero, nor do they establish that no event occurred outside the record's reporting scope. Interpretation depends on how events were defined, collected, monitored, and reported, details that are not reported in the registry record. The record does not provide event timing, severity definitions, or an account of completeness of follow-up for safety reporting.

The zero counts should therefore be read as a summary of what is posted, not as proof of absence of risk. The safety figures are separate from the estimates of physical activity and function and do not alter the statistical interpretation of those outcomes.

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

The posted data show that the BAILAMOS© group had a larger mean change in weekly moderate-to-vigorous physical activity than the health education group at post-intervention 4 months. The mean difference is 70.0 minutes/week, with a reported interval from 63.06 to 76.94 and an unadjusted p < 0.001. This is a group-level comparison on a questionnaire-based measure, not a prediction of what any particular participant experienced.

The result does not, by itself, establish whether the difference is meaningful to participants. The registry does not report a benchmark for a meaningful change in activity. Nor does the result establish that the difference persisted after the stated assessment, because a later follow-up result is not included in the posted primary outcome. The registry's stated purpose includes health outcomes beyond physical activity, but evidence for those outcomes must be considered separately.

The secondary outcomes do not all show the same degree of statistical precision. Their results cannot be treated as definitive confirmation without knowing the analysis plan and how multiple comparisons were handled. The posted comparisons are unadjusted, and details of the trial's original statistical methods are not reported in the registry record.

Randomization is an important design feature for comparing groups, but it does not remove all uncertainty about interpretation. The registry does not provide full participant flow, adherence, missing-data handling, or analysis-population details. The intervention description is also incomplete in places. These limits do not negate the posted numbers, but they matter when assessing how broadly the results can be applied and how robustly they represent the randomized comparison.

The record also reports zero serious adverse events, other adverse events, and deaths in both groups. Those entries describe the registry's safety reporting and should not be interpreted as proof that risk was absent. In sum, the posted result is evidence about a difference in average questionnaire-reported activity change at the stated timepoint. It is not, on its own, a comprehensive conclusion about overall health effects, long-term outcomes, individual responses, or safety.

17. Why This Trial Matters Statistically

This trial is statistically informative because it sets a behavioral intervention against an active health education comparator and reports a continuous primary outcome in its original units. The randomized parallel-group structure gives a recognizable framework for estimating a group contrast, while the mean difference and its interval communicate both the direction and precision of that contrast. The primary result is therefore more informative than a p-value alone.

The outcome is also connected to an important measurement distinction. Weekly activity is assessed by questionnaire rather than a direct movement measure, and it captures reported frequency and duration across lifestyle activities. Statistical interpretation must keep the measurement method in view: a precise comparison of questionnaire responses is not automatically interchangeable with a direct measure of activity or with a clinical outcome.

The posted data also illustrate why a statistically clear primary comparison does not resolve every question. Secondary outcomes measure different constructs and have different precision. The registry does not report multiplicity handling, the analysis plan, or missing-data methods, so the strength of evidence across the full outcome set cannot be assessed as though each comparison stood alone.

Finally, the planning illustrations make clear that sample-size requirements depend on the effect a study aims to detect and on assumptions about allocation, variability, and analysis. They should be read as design scenarios, not as retrospective measures of trial quality. Distinguishing the primary estimate, its uncertainty, secondary evidence, safety reporting, and the limits of registry detail is central to a careful statistical reading.

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.

Several trial-specific details that would help interpret the estimates are not reported in the registry record. Although the study is identified as randomized, the sequence generation and allocation concealment procedures are not described. Masking is listed as none, but the record does not specify whether outcome assessors or data analysts were masked. The full eligibility criteria and baseline characteristics are not included in the registry record posted for this analysis.

The intervention descriptions are incomplete. The dance program description ends during the account of the maintenance phase, and the health education description ends before its full content is stated. The registry therefore does not establish all program components, attendance expectations, adherence, or the amount of contact in each group. This limits the ability to reproduce the comparison or assess how closely it represents the intended program.

Only the primary outcome at post-intervention 4 months is described in the posted primary results. Longer-term outcomes and participant flow are not available in the record details. Endpoint counts vary across some secondary measures, but the reasons are not reported. The registry also does not explain missing-data handling or identify the analysis population.

Analysis details are limited: no statistical analysis entries are listed, and multiplicity procedures, model specification, covariate adjustment, sensitivity analyses, and protocol deviations are not reported. The primary interval's confidence level is not stated. Finally, because the primary measure is questionnaire-based and no meaningful-change threshold is reported, the clinical interpretation of the numerical difference remains uncertain. These limitations concern what can be evaluated from the registry record and do not establish that the trial investigators did not collect or analyze the information.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: BAILA: Being Active, Increasing Latinos Healthy Aging — NCT01988233.
• Registry record last updated 2022-07-27; status last verified 2022-07.
• Results first posted 2022-07-27.
• 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

BAILA, listed as NCT01988233, was a completed randomized, parallel-group trial with no masking listed. Enrollment was 333, with 167 participants assigned to the BAILAMOS© Dance Program and 166 to the Health Education Control Group. The primary endpoint was change in weekly moderate-to-vigorous physical activity from baseline to post-intervention 4 months, assessed by the CHAMPS PA Questionnaire.

The registry posts a mean difference of 70.0 minutes/week, an interval from 63.06 to 76.94, and an unadjusted p < 0.001. Three secondary outcomes are listed: 400 meter walk time, cognitive function, and self-reported functional limitations. No statistical analysis entries are listed. Details of multiplicity, missing-data methods, the original sample-size justification, and the investigator analysis plan are not reported in the registry record.