Exercise From Afar: Progressing At Risk Individuals to Independent Exercise: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Exercise From Afar: Progressing At Risk Individuals to Independent Exercise (NCT06667817), a randomized na study. The primary outcome is Determine the Impact of a Technology-driven Exercise Program on Exercise Adherence..

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. Participants were assigned to an exercise group or a control group. The exercise intervention was delivered through a smartphone application; control participants completed assessments without receiving an intervention. The study is listed as completed, with Emporia State University as sponsor. The phase designation is NA.

The registry enrollment is 52. The study description separately states that underactive adults (n=50) would be recruited. These are distinct registry entries: the enrollment field gives the recorded enrollment, while the study description gives the recruitment figure in its narrative. The record does not explain the difference between them. Participants were described as ages 40-70 years and from federally designated rural and frontier Kansas counties. Specific eligibility criteria are not reported in the registry record.

After recruitment and screening, participants were to complete baseline physical fitness and health assessments supervised by the research team. The exercise group received app-delivered programming and could access recorded instruction videos during the study. The app was also intended to organize videos into structured sessions and enable exercise tracking and progression. Control participants completed baseline and follow-up assessments but received no exercise intervention.

The primary adherence measure covers 16 weeks per participant enrolled and applies only to exercise participants. The registry gives the study start as 2024-10-31 and primary completion as 2025-08-19. The record does not report a phase, masking procedures beyond none, or a detailed allocation procedure. A protocol-level account of how randomization was generated or concealed is 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.

Before assignment: We enrolled 2 extra participants in anticipation of attrition rates (drop-outs).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: CON participants did not receive the exercise intervention, and thus were not included in data analysis for the exercise adherence outcome measure. Two participants were lost to follow-up and therefore are not included in EX data reporting.

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 Determine the Impact of a Technology-driven Exercise Program on Exercise Adherence., measured over 16 weeks per participant enrolled.

The primary endpoint is exercise adherence, measured as the percentage of total exercise sessions completed during the 16-week exercise study period. It is reported as a mean with a standard deviation. Exercise participation was to be tracked and recorded for exercise-group participants. Control participants were not included in this outcome because they were not assigned exercise sessions and did not complete exercise during the study period.

Adherence is a process measure: it describes participation in the intervention as recorded by the study team, rather than a health outcome or a direct measure of dementia risk. It is relevant to understanding whether participants engaged with the app-delivered program as intended. The investigators hypothesized moderate to high adherence, specified as 70-80% of total sessions completed. That range is the stated hypothesis, not the observed result.

The posted exercise-group result is a mean of 23.48 percent of sessions completed, with a standard deviation of 39.9, among 23 participants. Two participants were lost to follow-up and were not included in the exercise-group data reporting. The registry record does not describe how missing session records, if any, were handled. Because adherence was not measured as a comparable outcome in the control group, this endpoint does not provide a randomized between-group estimate.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry reports a continuous primary outcome summarized by a mean and standard deviation. Those summaries answer different descriptive questions. The mean gives the arithmetic average of the recorded session-completion percentages in the analyzed exercise group. The standard deviation describes how dispersed individual observations are around that average. Neither statistic alone describes every feature of the distribution.

What does the mean describe?

For this endpoint, each participant's adherence is expressed as the percentage of total exercise sessions completed over the 16-week study period. The group mean of 23.48 is the average of those participant-level percentages for the 23 participants included in the exercise-group reporting. It is not the percentage of participants who adhered, and it is not a comparison with control. A group average can also conceal differences between participants, which is one reason the accompanying standard deviation matters.

How should the standard deviation be read?

The reported standard deviation is 39.9. In general, a standard deviation summarizes the typical spread of observations around a mean, with larger values indicating greater dispersion in the observed data. It does not tell the reader the range of participant values, the number of participants at any particular adherence level, or the uncertainty around the mean. Those questions require information beyond a mean and standard deviation. No participant-level distribution or confidence interval for the mean is reported in the registry record.

Because adherence is expressed as a percentage, the measure is bounded. In general, bounded outcomes can have distributions that are not symmetric, especially when observations gather near a boundary. A mean and standard deviation may then be an incomplete description of the shape of the data. The registry record does not report a distributional assessment or a separate analysis method intended to address such features, so no conclusion about the shape of these adherence observations is warranted.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with the data under a specified statistical procedure and conveys uncertainty about an estimated quantity. An interval for a mean would help readers assess the precision of the average adherence estimate. The registry record does not report a confidence interval for this outcome. The standard deviation should not be interpreted as a substitute: it concerns variation among observations, whereas a confidence interval concerns uncertainty in an estimate.

Why is there no treatment-effect estimate?

The study is randomized and parallel-group, but the primary adherence outcome is restricted to exercise-group participants. The registry explicitly says control participants were not included because they did not complete exercise during the 16-week period. Consequently, the posted endpoint lacks a comparable control-group measurement. A treatment-effect estimate ordinarily contrasts outcomes between groups on a common endpoint; it cannot be recovered from an exercise-group mean alone. The registry does not report a p-value, confidence interval, or adjusted or unadjusted effect estimate for a two-arm comparison of adherence.

More generally, a p-value addresses how compatible observed data are with a specified null hypothesis under an analysis model. It does not measure the size or practical importance of an effect, and it does not replace an estimate with uncertainty. No p-value for a comparative primary-outcome analysis is reported. The record also does not identify a statistical model or test for the adherence outcome. It would be inappropriate to infer a test from the descriptive summaries.

What does over-dispersion mean in general?

Over-dispersion is a general concern when observed variability is greater than a statistical model assumes. If a model understates variability, its standard errors and inferential results can be too optimistic. The registry does not report a count model for session completion, a model-based dispersion parameter, or an analysis of over-dispersion. Since the primary result is reported as a mean and standard deviation, over-dispersion should be treated as a general methodological concept rather than a demonstrated feature of this trial's analysis.

What can planning calculations tell readers?

In general, sample-size planning calculations depend on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. They are planning illustrations, not observed outcomes or measures of the strength of evidence after a trial. The registry record does not report its own sample-size justification. It also does not report a two-arm observed effect for the adherence outcome from which a comparative planning illustration could be interpreted. No sample-size conclusion should be drawn from the descriptive adherence result alone.

The registry gives no statistical analysis plan for the primary endpoint, no interim-analysis information, and no inferential results for a between-group comparison. The absence of those details means that the reported mean and standard deviation should be read as descriptive summaries, not as the output of an assumed statistical test. The record does not report transformations, covariate adjustment, handling of repeated measures, or sensitivity analyses for this endpoint.

10. Confidence Intervals for Each Arm

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

R code and output

arm <- c("Exercise Group")
n   <- c(23)
m   <- c(23.48)
sp  <- c(39.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Exercise Group  23  23.480  39.900  6.226  40.734

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, but no secondary outcome results are posted. It reports no analyses in the registry record. With no reported secondary results or inferential analyses, the record does not permit an assessment of how multiplicity across outcomes or tests was handled. A multiplicity procedure, such as an adjustment to control the chance of false-positive findings across several tests, is not reported in the registry record. It should not be assumed that an adjustment was or was not used outside the information recorded there.

For the primary adherence endpoint, the registry reports the exercise-group mean and standard deviation for 23 participants. Two participants were lost to follow-up and are not included in the exercise-group reporting. The record does not state whether their missing adherence data were treated as missing entirely, partially observed, or handled using an imputation or other method. It also does not report a sensitivity analysis that would show how assumptions about those missing observations affect the result.

The analysis population is described for this endpoint: control participants were excluded because they received no exercise intervention and completed no exercise sessions during the study period. The record does not specify whether the exercise-group analysis follows assignment regardless of participation, or whether any additional population definitions were used. A detailed intention-to-treat or per-protocol analysis population is not reported in the registry record. These distinctions matter because an adherence summary among participants with reported data answers a different question from an estimate based on all randomized participants.

No interim analyses, stopping rules, or prespecified statistical analysis plan are reported in the registry record. The record also does not describe how multiple endpoints were ranked or selected for testing. These omissions limit assessment of the analysis process, but they do not establish that such procedures were absent from study conduct outside the registry entry.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry reports zero serious adverse events and zero other adverse events for the exercise group, among 25 participants at risk, and the same event counts for the control group, among 27 participants at risk. It reports zero deaths in both groups. No top serious adverse-event terms are listed.

These figures are safety summaries for the groups and should be read separately from the primary adherence analysis. The adherence result includes 23 exercise participants, while the safety record lists 25 exercise participants at risk. The registry does not explain this difference. The safety denominators therefore should not be replaced with the adherence analysis count, or treated as evidence that the endpoint populations were identical.

Zero recorded events means that the registry reports no events in the categories counted for this study. It does not prove that the risk of an event is absent, and the record does not provide confidence intervals or a comparative safety analysis. The registry also does not describe event definitions, surveillance procedures, or a detailed accounting of all safety events beyond the reported categories. The figures document what is posted, not a guarantee that no event could occur.

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

The primary result is a descriptive estimate of session completion among exercise-group participants included in the registry's adherence reporting: the mean is 23.48 percent, with a standard deviation of 39.9, for 23 participants. It characterizes recorded participation in the app-delivered exercise program over the 16-week period. The finding is not an estimate of change in health, physical fitness, brain plasticity, or dementia risk.

The investigators' stated adherence hypothesis was 70-80% of total sessions completed. The posted mean and that hypothesis are distinct pieces of information. The registry does not report an inferential test against the hypothesis or a confidence interval for the mean. Interpretation should therefore remain descriptive rather than treating the hypothesis as a formal comparator or the result as a statistically tested difference.

The outcome does not show whether the exercise program changed health outcomes relative to control. Although participants were randomized, control participants did not contribute an adherence value because they did not receive exercise sessions. The record does not post a comparative analysis of adherence, nor does it report secondary outcome results. A conclusion about intervention effects on health outcomes cannot be drawn from the adherence result.

The mean also does not explain individual reasons for completing fewer or more sessions, whether app engagement affected participation, or whether adherence differed by participant characteristics. The record does not provide participant-level values or the analysis needed to answer those questions. The standard deviation conveys variability but does not identify its sources. Two participants lost to follow-up and were excluded from exercise-group data reporting; the registry does not describe the missing-data method or the possible effect of their unobserved adherence.

The appropriate scope of the result is consequently narrow: it reports an average adherence percentage among the analyzed exercise participants. It does not establish that the program is effective or ineffective, and it does not estimate a causal effect on dementia-related risk. Further interpretation would require outcome data and analyses not reported in the registry record.

14. Why This Trial Matters Statistically

Adherence is an important statistical feature of an exercise intervention because outcomes depend in part on whether participants engage with the prescribed program. Reporting a mean and standard deviation gives readers an initial description of participation and its variability, rather than relying only on a broad statement that an intervention was offered. In this trial, the adherence result concerns app-delivered exercise among rural adults described as underactive.

The randomized parallel-group design is relevant to the broader study question, but the endpoint definition has a narrower scope: it is measured only in the exercise group. This illustrates a distinction between a trial's design and the estimand answered by a particular outcome. Randomization supports between-group comparisons when a common outcome is measured and analyzed in both groups; it does not turn an intervention-only process measure into a comparative treatment-effect estimate.

The registry's stated adherence hypothesis and the posted descriptive result also illustrate why prespecified expectations should be kept distinct from inferential evidence. A hypothesis can explain what investigators anticipated, while a mean describes the observed group data. Without a reported confidence interval or test, the precision and statistical compatibility of the estimate with the hypothesized range cannot be evaluated through the registry entry.

Finally, the record makes analysis-population and missing-data issues visible: two exercise participants were lost to follow-up, and the adherence result excludes them, while the safety record uses a different at-risk count. Clear reporting of denominators and handling of missing outcomes is essential to understanding exactly which participants contribute to each statistic. These features make the trial useful for learning how endpoint choice, comparison groups, and analysis populations shape what a posted result can support.

15. Limitations

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

The primary outcome is a process measure limited to the exercise group. Control participants were excluded because they did not receive the intervention, so the registry does not provide a randomized comparison for adherence. The result cannot be interpreted as a between-group effect, even though the overall study is randomized.

The registry reports a mean and standard deviation but no confidence interval, p-value, or inferential analysis for the endpoint. It does not report participant-level adherence values or a distributional summary that would clarify the shape and spread of the observations. As a percentage measure, adherence is bounded; in general, this can make distributional assessment relevant, but the registry does not report such an assessment.

Two participants were lost to follow-up and are excluded from exercise-group data reporting. The registry does not describe the amount or pattern of missing adherence information, how missingness was handled, or whether sensitivity analyses were conducted. The resulting estimate may not describe all participants assigned to exercise, and the record does not quantify how the exclusions affect the summary.

The registry lists six outcome measures but posts no secondary results. It does not report the statistical analysis plan, sample-size justification, interim analyses, multiplicity procedures, or detailed eligibility criteria. These omissions limit assessment of prespecification and the broader study findings. The record also lists 25 exercise participants at risk for safety summaries but gives an adherence analysis count of 23; it does not explain the difference. These limitations concern what can be learned from the registry record and do not establish what may have been documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Exercise From Afar: Progressing At Risk Individuals to Independent Exercise — NCT06667817.
• Registry record last updated 2026-10-26; status last verified 2026-09.
• Results first posted 2026-10-26.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06667817 is a completed randomized, parallel-group study with no masking, sponsored by Emporia State University. It examined an app-delivered exercise program for underactive rural adults, with a control group that received no intervention. The registry enrollment is 52; the study description says underactive adults (n=50) would be recruited.

The primary outcome is the percentage of exercise sessions completed during 16 weeks. The exercise-group mean is 23.48, with a standard deviation of 39.9, among 23 participants. Two participants were lost to follow-up and are not included in that reporting. Control participants were excluded from adherence analysis, and no comparative primary-outcome estimate is reported. No secondary results are posted. Safety summaries report zero serious adverse events, zero other adverse events, and zero deaths in each group.