Comparison Effects Of Different Exercise Approaches On Type 2 DM Women: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparison Effects Of Different Exercise Approaches On Type 2 DM Women (NCT05479435), a randomized na study. The primary outcome is Glycosylated Hemoglobin Change.

2. Clinical Question

The trial addresses how different ways of organizing exercise relate to glycemic measurement in women with type 2 diabetes. The approaches differ in the support and choice described in the registry: the Blue Prescription group receives a personalized program and regular motivational or modifying contact; the video-based group follows a home program with investigator calls; and the supervised group exercises with a physiotherapist. These descriptions establish what was planned for each arm, but they do not establish how consistently participants followed the programs.

The registry’s background describes barriers to exercise, including motivation, time, support, symptoms, and concern about injury or hypoglycemia. Its rationale is that an approach offering choices and responding to preferences may address some barriers differently from a conventional home program or supervised exercise. That rationale is not evidence that one approach produced a greater HbA1c change. Because numerical endpoint results, uncertainty estimates, and a reported analysis contrast are not available in the registry record, the relative changes cannot be assessed from the record.

3. Trial Design

The registry describes a randomized, open-label, parallel-group trial of three behavioral exercise approaches in women with type 2 diabetes. Random allocation is intended to make the groups comparable on average at the start of a study, although it does not guarantee that every characteristic is balanced. The parallel design means participants are assigned to an approach rather than being described as receiving each approach in sequence. Masking is listed as none, so the record does not describe blinding of participants or study staff.

The registered enrollment is 60. The adverse-event record lists 20 participants at risk in each of the three groups, but those safety counts should not be treated as a report of the number included in each endpoint analysis. The number analyzed for HbA1c, exclusions after randomization, and the participant flow through follow-up are not reported in the registry record. The trial is listed as completed. Its start date is 2021-09-01, and its primary completion date is 2023-03-01. The phase is listed as NA.

The Blue Prescription arm combines a tailored exercise plan with weekly contact to support motivation or program modification and an activity diary. The video-based home arm receives exercise videos, performs the exercises three days a week, receives investigator calls about following the program, and keeps a diary. The supervised arm performs exercise three days a week under a physiotherapist’s guidance; each group is described as having a maximum of 10 people. The registry does not report the exercise content, intensity, duration of each session, or the length of the overall intervention apart from the primary endpoint’s 12-week measurement timeframe.

These arm descriptions distinguish the intended delivery models, not their achieved exposure. Adherence, attendance, changes to exercise plans, and use of other care are not reported in the registry record. Consequently, a comparison between assigned approaches would be interpreted as a comparison of the randomized strategies only if an analysis by assigned group were used; the analysis population and approach are not reported.

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: The participiants who diagnosed with Diabetes Mellitus Type 2, were recruited from Balikesir Provincial Health Directorate, Edremit District Health Directorates Healthy Life Center. They were 60 people who were assigned to the groups.

Overall Study

Reasons for not completing this period:

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 Glycosylated Hemoglobin Change, measured over Change from Baseline Glycosylated Hemoglobin at 12 weeks..

The primary endpoint is change from baseline in glycosylated hemoglobin at 12 weeks. Glycosylated hemoglobin, commonly abbreviated HbA1c, reflects glucose exposure over time and is used in diabetes care as a measure of glycemic status. The registry describes HbA1c as a blood test used to measure the effectiveness of diabetes treatment and sometimes to diagnose diabetes. It gives a generally accepted reference range of 4% to 6%.

Change from baseline focuses on how the measurement differs from a participant’s starting value by the specified follow-up time. A group mean change describes the average change among the participants included in that group’s analysis. It does not show how much each individual changed, and the standard deviation, if reported, describes variation among participant values rather than precision of the group mean.

The registry identifies the measure as continuous, with the mean and standard deviation as its summary format. However, numerical baseline values, follow-up values, changes, and uncertainty estimates are not reported in the registry record. The reference range is contextual information; it does not indicate the trial participants’ HbA1c values or the direction or size of any change. Without the posted endpoint results, the extent and precision of the observed changes cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

Randomization assigns participants to study groups by chance. In general, this helps reduce systematic differences between groups at the point of assignment, including differences that investigators may not have measured. It does not guarantee identical groups, and it does not protect against differences arising after assignment, such as uneven follow-up or differences in adherence. The registry lists allocation as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record.

The trial is described as parallel-group and unmasked. A parallel design compares groups assigned to different approaches over the study period. With no masking, participants and study staff may know which approach is being delivered. The record does not specify whether outcome assessors or laboratory staff were masked. HbA1c is a laboratory measurement, but that general feature does not establish what blinding procedures were used in this trial.

What does a mean change represent?

For a continuous outcome such as HbA1c, a mean change is an average of participant-level changes from baseline to follow-up. A change score can describe movement over time, while a comparison between groups asks whether the average movement differs across assigned approaches. These are distinct questions: observing a change within one group does not, by itself, show that the group changed differently from another group. The registry names mean and standard deviation as the summary measures, but numerical endpoint summaries are not reported in the registry record.

Standard deviation describes the spread of participant measurements around a group mean. It is not the same as a confidence interval, which describes uncertainty in an estimated quantity. In general, a mean can be estimated more precisely when there is less variability and more usable information, but precision also depends on the analysis and the amount of missing data. The record does not report endpoint standard deviations or confidence intervals, so the precision of any HbA1c estimate cannot be judged.

Why does the analysis contrast matter?

A three-arm study can support several possible comparisons, including comparisons between particular pairs of approaches or an overall test across groups. These answer different questions. An overall test can assess whether results vary across groups without identifying which pair differs; a pairwise comparison focuses on a specified pair. The registry says the primary outcome has several categories or time points and is not reduced to one comparison. It does not report a single contrast, its estimate, or the model used to obtain it.

When outcomes are measured repeatedly or analyzed through several categories, the analysis must specify how those observations are represented and which result is emphasized. Repeated measurements on the same participant are related, rather than independent. In general, an analysis that accounts for that relationship can differ from an analysis that treats observations as independent. The measurement schedule beyond the 12-week primary timeframe, the model for repeated measures, and the handling of the categories are not reported in the registry record.

How should planning illustrations be read?

Planning illustrations based on an observed effect are not the same as a trial’s original sample-size justification. The registry describes an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is a stated fraction of the observed effect. It also distinguishes participant counts per arm for non-time-to-event outcomes from total event counts for time-to-event outcomes. These are assumptions for planning illustrations, not evidence about the trial’s design rationale or the uncertainty of its observed findings.

No planning count or observed effect is reported in the registry record. The trial’s sample-size justification, target effect, and statistical power plan are not reported in the registry record. A sample-size illustration is a planning aid: it describes the amount of information that might be needed under specified assumptions. It is not observed power and cannot substitute for the observed estimate and its uncertainty.

What can be concluded without the numerical analysis?

Statistical interpretation depends on the estimate, its uncertainty, the analysis population, and the comparison being addressed. The registry provides the outcome definition and design details, but not the primary endpoint values or analysis results. The correct statistical conclusion is therefore about the limits of the record: the design and measurement question are described, while the magnitude and precision of the results are not reported. General statistical concepts can clarify what the missing summaries would mean, but cannot supply them.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 26 outcome measures and 26 analyses. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. This creates an important interpretation question: which outcome contrast or time point was designated as the main test, and how were other analyses treated? The multiplicity strategy, including any adjustment or hierarchy among outcomes, is not reported in the registry record.

In general, assessing many outcomes or contrasts increases the opportunity for apparently unusual findings to arise by chance. Methods for addressing this can include defining a primary comparison in advance, adjusting for multiple testing, or clearly labeling secondary and exploratory analyses. These approaches serve different purposes. The registry does not identify which, if any, approach was used, so no claim about control of false-positive findings can be made.

Missing-data handling is also not reported in the registry record. The record does not give the number with HbA1c measurements at baseline and follow-up, reasons for missing measurements, or the method used to handle missing values. Those details matter because an analysis restricted to observed measurements may be affected if missingness is related to outcome or group assignment. The registry’s adverse-event counts do not establish the number included in the efficacy analysis.

The analysis population is not reported in the registry record. It is therefore unclear whether results, if available elsewhere, would be based on all randomized participants, participants who completed the intervention, or another defined group. The analysis model, covariate adjustment, and treatment of deviations from assigned exercise are also not reported. These omissions limit assessment of how well the reported analysis, if any, answers the randomized comparison.

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 adverse-event record lists zero serious adverse events and zero deaths in each group. It lists 20 participants at risk in each group for the serious-event counts. It also lists zero other adverse events in each group, with 20 at risk for those counts. These are the registry’s recorded figures; they do not establish that no event occurred outside the reporting definitions or observation period.

In general, an adverse-event count is interpreted in relation to who was monitored, how events were defined, and how long follow-up lasted. The registry record does not report the event definitions, ascertainment procedures, follow-up duration for safety, or detail about events not classified as serious. It also does not provide additional clinical descriptions of events. Zero recorded events should therefore be read as a registry count, not as proof that an approach has no risks.

The at-risk counts are safety denominators and should not automatically be used as the denominators for HbA1c analyses. Safety and efficacy populations can differ, and the registry does not report the analysis population for the primary endpoint. These safety figures do not provide comparative evidence about efficacy, and they do not determine whether differences in exercise support or delivery affected HbA1c.

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

The trial’s question is relevant to the design of exercise programs: it compares an option-oriented, personalized approach with a video-based home program and supervised group exercise among women with type 2 diabetes. The registry describes the approaches and identifies HbA1c change at 12 weeks as the primary endpoint. This allows readers to understand the intended comparison and the main measurement, but not the numerical result.

The registry record does not report the primary endpoint estimates, group-level changes, variability, confidence intervals, or statistical tests. Therefore, it does not support a conclusion that the approaches produced the same or different HbA1c changes. It also cannot establish the size, direction, or precision of any change. Lack of a reported estimate is not evidence of no effect, and a description of the intended intervention is not evidence of effectiveness.

Even if numerical differences were available, interpretation would require attention to uncertainty, the chosen comparison, missing data, and the analysis population. A statistically distinguishable estimate, in general, is not automatically a clinically important one; conversely, an uncertain estimate does not prove that meaningful differences are absent. The clinical interpretation would also depend on how closely the delivered programs matched their descriptions and how consistently participants engaged with them. Those adherence and implementation results are not reported in the registry record.

The registered HbA1c reference range of 4% to 6% provides context for the measurement, but it does not describe the participants’ baseline status or their follow-up values. The registry’s listed secondary outcomes broaden the study’s measurement scope, but their numerical results are likewise not reported in the record used for this account. The most that can be concluded is that a randomized comparison was registered and completed, with a defined primary measurement and three described exercise strategies. Comparative findings cannot be recovered from those design details alone.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it compares different delivery models rather than simply contrasting exercise with no exercise. The approaches vary in personalization, contact, and supervision. Such differences can matter when the question concerns implementation as well as the measured outcome: an exercise strategy is a package of planned activities and support, not only the exercise itself. The registry descriptions make those intended distinctions visible.

The randomized parallel design is suited to comparing assigned approaches, while the unmasked status and the three-arm structure make clear why the analysis plan matters. A reader needs to know which group contrasts were prioritized, how the primary endpoint’s categories or time points were handled, and which participants contributed to each estimate. The registry says the primary outcome was not reduced to one comparison and does not report those analytical details. That limits the conclusions that can be drawn from the record.

The trial also illustrates why outcome definitions and results should be read separately. Naming change in HbA1c at 12 weeks identifies the intended primary measurement, but it does not reveal the observed changes. A complete statistical account needs estimates and uncertainty, alongside transparent reporting of missing observations, analysis populations, and the treatment of multiple outcomes. Those details are not reported in the registry record.

Finally, the recorded absence of adverse events is useful descriptive information, but it does not replace efficacy results or a fuller safety account. The distinction between what was planned, what was measured, and what was observed is central to interpreting any trial. Here, the planned comparison is described, while the numerical outcome evidence needed to assess between-group patterns is not reported in the registry record.

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 main limitation for interpreting this trial from its registry record is that numerical primary outcome results are not reported. Without group estimates and their uncertainty, the size, direction, and precision of HbA1c changes cannot be described. The registry also notes that the primary outcome has several categories or time points and is not reduced to one comparison, leaving the central contrast unclear.

Details needed to assess the analysis are not reported in the registry record. These include the analysis population, participant flow, missing-data methods, model specification, and any covariate adjustment. The record does not explain how the multiple outcome measures and analyses were prioritized or whether any multiplicity method was applied. It also does not provide the original sample-size justification or its assumptions.

The descriptions of exercise delivery do not report exercise intensity, session duration, overall program duration, adherence, attendance, or changes in the planned programs. The record therefore does not establish how much of each approach participants actually received. Masking is listed as none, but the record does not specify whether outcome assessors or laboratory staff were masked. Participant characteristics beyond the condition and population description are not reported in the registry record, limiting assessment of how broadly the results might apply.

The safety record gives counts of zero events but does not report event definitions, the safety observation period, or detailed event information. Finally, registry descriptions and completion status do not, on their own, provide a full account of trial conduct or analysis. These limitations concern the information available in the registry record and should not be mistaken for evidence that a particular method was or was not used.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Comparison Effects Of Different Exercise Approaches On Type 2 DM Women — NCT05479435.
• Registry record last updated 2025-06-12; status last verified 2025-05.
• Results first posted 2025-06-12.
• 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

NCT05479435 is a completed, randomized, unmasked, parallel-group study sponsored by Istanbul Medipol University Hospital. It concerns women with type 2 diabetes and compares a Blue Prescription program, a video-based home exercise program, and supervised group exercise. Registered enrollment is 60. The listed start date is 2021-09-01, and the primary completion date is 2023-03-01.

The primary endpoint is change from baseline in glycosylated hemoglobin at 12 weeks. The registry lists 26 outcome measures and 26 analyses, and notes that the primary outcome has several categories or time points rather than a single reduced comparison. Numerical primary results and the analysis details needed to interpret them are not reported in the registry record.

The adverse-event record reports zero serious events, zero other events, and zero deaths in each group, with 20 at risk in each group for the reported event counts. Those figures are descriptive and do not establish the efficacy findings or the full safety profile.