Intensive Aerobic and Resistance Exercise Program (IAREP): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intensive Aerobic and Resistance Exercise Program (IAREP) (NCT06401733), a non-randomized na study. The primary outcome is Change in Cognitive Function Based on Risk Stratification Score (RSS).

2. Clinical Question

3. Trial Design

This completed study evaluated a 12-week Intensive Aerobic and Resistance Exercise Program in middle-aged and older adults with type 2 diabetes mellitus. The registry lists an enrollment of 58 and identifies the sponsor as the National University of Singapore. The study began on 2023-07-21, had a primary completion date of 2025-03-31, and is recorded as completed. Its phase is listed as NA.

The design is recorded as non-randomized, with no masking and a sequential model. The intervention group received IAREP; the control group received usual care in Jurong polyclinic. The registry record does not describe the sequence or criteria used to assign participants, so the meaning of the sequential model for recruitment or allocation cannot be determined from the record alone. It also does not report whether participants could receive other exercise or health programs during the study.

The primary endpoint was change in cognitive function based on RSS, assessed at baseline and 12 weeks. Its summary measure was specified as the median, with inter-quartile range as the measure of dispersion. The record also lists secondary outcomes concerning metabolic health, inflammatory condition, physical performance, sarcopenia risk, blood pressure, physical activity, diabetes self-care, and health practice. Results for these outcomes are not reported in the registry record.

The non-randomized allocation is important when interpreting any intended comparison. Random assignment can, in general, reduce systematic differences between groups at the start of a study; it is not part of this design. Without reported group characteristics, assignment details, or adjusted analyses, the extent to which the groups were comparable cannot be assessed. The registry record gives no detailed protocol, statistical analysis plan, sample-size justification, or information about interim analyses.

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: Both intervention and control groups. Post-intervention of RSS scores (cutoff score of 0.3), those higher than 0.3 have a higher risk of cognitive impairment. The lower the score, the lower the risk of cognitive impairment.

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 Change in Cognitive Function Based on Risk Stratification Score (RSS), measured over Baseline and 12 weeks.

The primary endpoint is change in cognitive function based on the Risk Stratification Score. The record describes RSS as a score on a scale from -3.4 to 6.8 and states that higher scores represent worse outcomes. RSS was measured at baseline and 12 weeks, allowing the planned assessment to consider the score before and after the intervention period. The record specifies the median as the summary measure and the inter-quartile range as its dispersion measure.

The score is also presented as a risk-stratification measure: after intervention, a score higher than 0.3 indicates higher risk of cognitive impairment, while a lower score indicates lower risk. This cutoff provides a way to interpret the scale in terms of risk categories, but it does not replace reporting the underlying score distribution or change over time. The record does not report how RSS is constructed, how it was validated, or how the cutoff was selected.

RSS is used as the primary cognitive endpoint in a study that also planned to assess metabolic, inflammatory, physical, vascular, and health-practice outcomes. However, no baseline or follow-up medians, inter-quartile ranges, change estimates, or group comparisons appear in the registry record. The endpoint’s definition and measurement schedule are available, but its observed results and precision are not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is described using a median and inter-quartile range. In general, the median is the middle value after observations are ordered, and the inter-quartile range describes the spread of the central portion of those observations. These summaries can be useful when a score distribution is skewed or contains values that make a mean and standard deviation less representative. The registry record does not state why this summary approach was chosen for RSS.

What does the median and inter-quartile range convey?

In general, a median indicates the location of a distribution without requiring the values on either side to be evenly balanced. The inter-quartile range indicates dispersion, but it does not show every feature of the distribution. Two groups can have similar medians and inter-quartile ranges while differing in other aspects of their score distributions. For this endpoint, the record specifies these summaries but does not report their observed values at baseline or 12 weeks.

The endpoint is framed as change between baseline and 12 weeks. In general, an analysis of change can compare each participant’s follow-up score with their own baseline score, or it can compare group-level summaries at each time point; those approaches answer related but different questions. The registry record does not report which calculation was used, whether the primary comparison concerned within-group change or a difference between groups, or how repeated measurements were handled. No change estimate is reported, so none can be interpreted.

How should the risk cutoff be read?

The record states that a post-intervention RSS higher than 0.3 indicates higher risk of cognitive impairment, and that lower scores indicate lower risk. This is a classification aid rather than a reported treatment effect. In general, applying a cutoff can simplify interpretation, but it can also conceal how far scores lie from the threshold and how uncertain a classification is. The record does not report the number of participants in either risk category, a validation assessment, or the rationale for selecting the cutoff.

The study is non-randomized and unmasked. In general, randomization aims to balance both measured and unmeasured prognostic factors between treatment groups, while masking can limit some measurement and behavioral influences. Neither feature is recorded for this study. The control group’s usual care provides a comparator, but it does not make the groups equivalent by itself. Without information on group assignment, baseline characteristics, co-interventions, or adjustment methods, confounding cannot be evaluated. The registry record does not report adjusted or unadjusted effect estimates.

The study model is listed as sequential, but the record does not explain what sequence refers to or how it affected enrollment or treatment assignment. That label therefore cannot be used to infer a specific allocation procedure, staged design, or analysis method. The recorded design details are limited to non-randomized allocation, no masking, the sequential model, and the intervention and control descriptions.

What can be concluded from the listed analyses?

The record lists 11 outcome measures and 0 analyses. No test statistic, p-value, confidence interval, or outcome estimate is available. In general, a confidence interval describes the range of effect values compatible with the data and the method used; its width conveys precision. Without an estimate and interval, the magnitude and precision of a result cannot be assessed. The registry record does not report whether any analyses were performed outside the registry entry.

The record does not state whether analyses were based on all enrolled participants, only participants with complete measurements, or another analysis population. It does not report missing-data counts or methods. In general, missing measurements can affect estimates when their absence is related to participant characteristics or outcomes, and the analysis population determines which observations contribute to a result. Neither issue can be assessed for RSS or the secondary outcomes from the registry record.

There are multiple listed outcomes, but no multiplicity strategy is reported. In general, examining several outcomes can increase the chance of finding an apparently notable result by chance if results are interpreted without regard to the number of tests. A prespecified hierarchy, adjustment method, or clearly exploratory interpretation can help readers understand that issue. The registry record does not identify such an approach, so it is not possible to determine how the outcome set was handled statistically.

Any sample-size planning based on an observed effect is an illustration, not evidence of the study’s design justification or its achieved ability to detect an effect. The record’s stated assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. These are planning assumptions, not a report of the trial’s own sample-size rationale. Such calculations are not observed power, and no planning output or effect estimate is reported in the registry record. The registry record does not report the protocol, sample-size justification, interim analyses, or a full statistical plan.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 11 outcome measures, including the primary RSS endpoint and secondary measures addressing metabolic health, inflammatory condition, physical function, sarcopenia risk, blood pressure, physical activity, diabetes self-care, and health practice. It records 0 analyses and does not provide outcome estimates. The breadth of the planned outcome set is therefore known, but the results and the analysis choices for those outcomes are not.

No method for handling multiplicity is reported in the registry record. In general, when multiple outcomes are tested, interpreting each result as though it were the sole planned test can make chance findings more likely. Statistical plans may address this through a hierarchy of outcomes, adjustment procedures, or an explicit distinction between confirmatory and exploratory analyses. The record does not indicate whether any such approach was specified or used.

Missing-data methods and analysis populations are also not reported. There are no reported counts of participants with endpoint measurements at baseline or follow-up, and no description of how incomplete measurements were handled. The record does not say whether analyses were intended to include all enrolled participants, participants with available data, or another defined group. These omissions matter because the analytic population and the pattern of missing measurements can influence the meaning and reliability of an estimate.

The registry record also does not report a statistical analysis plan, protocol-level analysis details, or interim analyses. With no posted estimates or analysis methods, readers cannot assess whether outcome analyses followed prespecified procedures, how uncertainty was quantified, or whether any adjustments were made for the non-randomized design.

11. 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 serious adverse events, other adverse events, and deaths separately for the intervention and control groups. For the intervention group, 0 serious adverse events and 0 other adverse events were recorded among 25 participants at risk; deaths were recorded as 0. For the control group, 0 serious adverse events and 0 other adverse events were recorded among 28 participants at risk; deaths were recorded as 0. No serious adverse-event terms are listed.

These are the event counts recorded in the registry, not a detailed account of the safety data. The record does not describe the adverse-event collection period, definitions, monitoring procedures, severity criteria, or whether events were actively solicited. It also does not report the number of participants who completed follow-up or provide event-level descriptions. Accordingly, zero recorded events should be read as a description of the posted counts, not as proof that no adverse events occurred or that the intervention has no safety risks.

The counts are not comparative evidence of safety. This study used non-randomized allocation, and the registry record does not provide a statistical comparison of adverse events. Differences in participant characteristics, observation time, or event reporting could affect how group counts should be compared. The available entries support only a cautious statement about the events recorded for the groups.

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

The registry record establishes that a completed study evaluated a 12-week intensive aerobic and resistance exercise program in adults with type 2 diabetes mellitus, with usual care as the control condition. It identifies change in RSS as the primary endpoint, defines the direction of the score, and states the baseline and follow-up timing. It also lists secondary areas of assessment and records adverse-event counts.

It does not report the RSS results or analyses for the primary or secondary outcomes. There is therefore no numerical basis in the registry record for describing the size, direction, or precision of an outcome change. A completed study is not, by itself, evidence that the intervention changed an outcome. Likewise, the absence of reported analyses is not evidence that the outcomes did not change.

The design further limits what a group comparison could establish. Participants were not randomly allocated, the study was unmasked, and the reason for assignment is not reported. Without information about baseline comparability, adjustment, and missing observations, any observed difference would require careful interpretation. Even a measured association between group and outcome would not, on the information in the record, demonstrate that the program caused that difference.

The RSS cutoff offers a way to categorize post-intervention risk, but the record does not give participant counts or score distributions relative to that threshold. The cutoff description should not be mistaken for evidence that risk categories changed. Similarly, the adverse-event entries document zero events of the listed types in the stated groups, but do not establish comprehensive safety or absence of risk.

The most defensible reading is that the registry describes the study design and planned outcome framework, while leaving the clinical outcome findings unreported. The record cannot establish whether IAREP was associated with a change in cognition, metabolic health, physical function, or any other listed outcome, nor can it establish an effect relative to usual care.

13. Why This Trial Matters Statistically

This study is statistically notable because its primary question concerns change in a cognitive-risk score while the design uses non-randomized allocation. The combination makes clear separation of intervention-associated change from group differences especially important. A comparator group can provide context, but without randomization and information about assignment and baseline characteristics, it cannot on its own rule out confounding.

The endpoint is a score with a stated direction and a risk cutoff. Reporting only whether scores fall on one side of a cutoff would not convey the full distribution or the amount of change. The record specifies median and inter-quartile range summaries, which describe the score’s location and spread, but it does not publish the corresponding values. Readers therefore have the endpoint definition without the information needed to judge its observed behavior or precision.

The study also covers several health domains, including cognition, metabolic and inflammatory outcomes, physical performance, blood pressure, activity, self-care, and health practice. Multiple outcomes can broaden the scientific questions addressed, while also making prespecification and clear multiplicity handling important. The registry record lists 11 outcome measures but does not describe a multiplicity approach or report outcome analyses.

Finally, the record highlights a distinction between study completion and transparent reporting of estimates. Without reported results, uncertainty measures, missing-data information, or analysis populations, neither statistical strength nor limitations of the observed outcome data can be examined. The registry entry remains informative about the intended measurements and design, but it does not permit readers to assess the primary outcome’s findings.

14. Limitations

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

The principal limitation for interpreting this trial is that outcome analyses are not reported in the registry record. The record identifies the primary endpoint, measurement schedule, summary approach, and secondary outcomes, but provides no observed RSS values, changes, group comparisons, confidence intervals, or test results. Results for the secondary outcomes are also not reported.

Non-randomized allocation creates a risk that the groups differed before the intervention. The registry record does not explain assignment procedures or provide baseline characteristics that would allow those differences to be assessed. No adjustment methods are reported. The absence of masking may also leave measurement or behavior open to influence, but the record does not describe outcome assessment procedures in enough detail to evaluate that possibility.

The RSS description gives its range, direction, and post-intervention cutoff, but does not report how the score was constructed, validated, or calibrated in this population. The record does not give the number of participants above the cutoff or describe how cutoff-based results would be analyzed. The interpretation of a score as a marker of risk should therefore be kept distinct from evidence of a change in cognitive function.

Information about intervention delivery and exposure is limited. The record names the 12-week IAREP program but does not report its detailed components, attendance, adherence, or deviations from the intended program. It does not provide the timing or completeness of outcome assessments, missing-data counts, or analysis populations. These details are relevant to understanding both the intervention actually received and the data included in any analysis.

The registry record does not report a statistical analysis plan, sample-size justification, interim analyses, or a multiplicity strategy. It also does not describe the period and procedures used for adverse-event monitoring. These reporting gaps prevent a full appraisal of the planned analysis, the precision of outcome estimates, and the completeness of safety ascertainment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Intensive Aerobic and Resistance Exercise Program (IAREP) — NCT06401733.
• Registry record last updated 2026-02-19; status last verified 2026-02.
• Results first posted 2026-02-19.
• 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.

18. Record Summary

The registry record describes a completed, non-randomized, unmasked, sequential study of a 12-week Intensive Aerobic and Resistance Exercise Program for middle-aged and older adults with type 2 diabetes mellitus. The control group received usual care in Jurong polyclinic. The listed enrollment is 58, and the study is sponsored by the National University of Singapore.

The primary endpoint is change in cognitive function based on RSS, measured at baseline and 12 weeks and summarized using the median and inter-quartile range. The record states that RSS ranges from -3.4 to 6.8, with higher scores representing worse outcomes, and that post-intervention scores higher than 0.3 indicate higher risk of cognitive impairment. It lists 11 outcome measures and records 0 analyses.

No primary or secondary outcome results, analysis populations, missing-data methods, or statistical plan are reported in the registry record. The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in each group. Those counts do not replace a detailed account of safety monitoring.