This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Metabolic Syndrome and Fall Risk (NCT02633891), a randomized na study. The primary outcome is Four Square Step Test (FSST).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02633891 |
| Phase | NA |
| Condition | Metabolic Syndrome, Autonomic Neuropathy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 12 |
| Arms in the primary outcome | 2 |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a study of people with metabolic syndrome and autonomic neuropathy. The brief summary identifies neuropathy and fall risk as concerns in this population. Although the trial enrolled 12 participants, the posted Four Square Step Test results include 3 participants in the balance exercise program arm and 4 in standard care. The endpoint record also describes follow-up and mobility-testing noncompletion.
Intervention
The intervention was a balance exercise program. Participants attended weekly group training sessions, kept a log of home activity, and were asked to perform balance exercises three times per week in a home-based program. The program was described as lasting three months.
Comparator
The comparison arm received standard care, described as weekly in-person general education classes about health and fall prevention. Participants in this arm did not take part in an exercise class.
Primary question
The primary endpoint was the Four Square Step Test (FSST), measured in seconds at 12 weeks. The clinical question is whether the posted FSST results describe different observed test performance between the randomized arms at that timepoint. The registry record does not report an inferential comparison, so the posted values do not establish whether any observed difference is distinguishable from random variation.
The registry describes a behavioral intervention study rather than a drug trial. Its stated purpose was to assess functional benefits and fall risk in people with metabolic syndrome and neuropathy. The endpoint itself measures performance on a balance task; it is not a direct count of falls. The posted result therefore addresses a specific test at a specified follow-up time, not every aspect of balance, neuropathy, or future fall risk.
3. Trial Design
The record identifies a randomized, single-masked, parallel study with behavioral interventions. It lists the phase as NA and reports enrollment of 12. The sponsor is the VA Office of Research and Development, and the study status is completed. The record reports a study start of 2017-01-02 and primary completion of 2022-03-28.
Participants were assigned to a balance exercise program or standard care. The exercise arm combined weekly group sessions with home practice and an exercise log. The standard-care arm involved weekly in-person general education about health and fall prevention, without an exercise class. The registry does not report who was masked, how allocation was generated or concealed, or the detailed procedures used to implement masking. Those design details are not reported in the registry record.
The primary outcome was the Four Square Step Test at 12 weeks. The record describes the outcome as a mean measured in seconds, with dispersion reported as the full range. The posted arm results are a mean of 11.04 seconds for 3 participants in the balance exercise program and a mean of 14.29 seconds for 4 participants in standard care. The corresponding full ranges are 9.9 to 12.93 seconds and 9.28 to 25.47 seconds.
The endpoint record notes that 2 participants in the balance exercise program were lost to follow-up and 2 did not complete the 12-week mobility testing, which included the FSST. In standard care, 1 participant was lost to follow-up. These notes are relevant when interpreting the smaller numbers contributing to the posted primary outcome. The registry does not report the detailed analysis plan, the intended analysis population, or the statistical method used for a between-arm comparison.
A secondary outcome is listed as the Dynamic Gait Index (DGI). The record does not provide an estimable two-arm comparison for that other endpoint. Thus, the available primary result is descriptive, while the record does not support a detailed account of statistical testing across outcomes.
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
| Stage | Balance Exercise Program | Standard Care |
|---|---|---|
| STARTED | 7 | 5 |
| COMPLETED | 5 | 4 |
| NOT COMPLETED | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: In the balance exercise program 2 participants were lost to follow up and 2 participants did not complete the 12-week mobility testing, which included the FSST. In the standard care group 1 participant was lost to follow up.
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.
| Characteristic | Unit | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 5 | 12 | |
| Age, Continuous | years | 66 (53 to 74) | 66 (59 to 75) | 66 (53 to 75) |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): White | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| BMI | kg/m^2 | 35.64 (26.5 to 49.2) | 38.16 (29.9 to 47.4) | 36.69 (26.5 to 49.2) |
| Fasting glucose | mg/dL | 133.86 (97 to 203) | 108.4 (91 to 130) | 123.25 (91 to 203) |
| Four square step test | seconds | 14.49 (8.62 to 31.56) | 13.01 (8.15 to 22.6) | 13.91 (8.15 to 31.56) |
| Dynamic Gait Index (DGI) | score on a scale | 7 (3 to 9) | 9 (5 to 12) | 7.73 (3 to 12) |
6. Primary Endpoint
The registry lists the primary outcome as Four Square Step Test (FSST), measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | seconds |
| Endpoint classification | not reduced to a single comparison |
The Four Square Step Test is a measure of proactive dynamic standing balance. In the task described by the registry, four canes are placed on the ground at right angles to one another. A participant begins in one of the squares and steps into each square in a specified sequence, moving as quickly as possible. The result is measured in seconds, so it records the time taken to complete this structured movement task.
The test is used to assess a functional aspect of balance: the ability to step in different directions while maintaining control. That makes it relevant to a study concerned with balance exercise and fall risk. It is nevertheless a test performance measure, not a direct measure of falls in everyday life, and it does not by itself measure neuropathy or identify the cause of a participant’s performance.
The primary endpoint was assessed at 12 weeks. The registry reports the arm means and full ranges, with the mean described as the outcome parameter. A full range gives the lowest and highest observed values in the reported group; it is not a confidence interval and does not express the precision of the mean in the same way. The ranges also do not substitute for a formal comparison between randomized arms.
The endpoint record lists 3 participants for the balance exercise program result and 4 for standard care. It also notes loss to follow-up and incomplete mobility testing in the exercise arm, and loss to follow-up in standard care. These details matter because the posted endpoint values describe participants with reported test results, not necessarily every person randomized.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary result is descriptive. The mean FSST was 11.04 seconds among 3 participants in the balance exercise program and 14.29 seconds among 4 participants in standard care. The full range was 9.9 to 12.93 seconds in the exercise arm and 9.28 to 25.47 seconds in standard care. Those are the arm-level summaries recorded for the 12-week endpoint.
The ranges indicate that observed times varied among participants, particularly in standard care. The ranges overlap, so the observed values are not separated into non-overlapping sets by arm. That observation is descriptive; it is not a hypothesis test and does not establish whether the arms differ. The registry record lists no analyses for this endpoint, and it does not report a p-value, confidence interval for an arm contrast, adjusted estimate, or other inferential comparison. No statistical significance conclusion can be drawn from the reported arm summaries alone.
The small numbers contributing to the endpoint deserve particular attention. The trial enrolled 12 participants, while the posted FSST means are based on 3 and 4 participants. The endpoint notes describe losses to follow-up and incomplete testing. With so few observed results, each participant’s performance can have substantial influence on an arm summary. A mean and a full range describe the available observations but offer limited information about how stable those summaries would be in another group of participants.
The direction of a time difference should also be interpreted narrowly. The test is recorded in seconds and asks participants to move as quickly as possible through a sequence. The posted values can be read as observed completion times for the participants with endpoint results. They do not establish that the exercise program caused a change, because no comparative analysis is reported and the endpoint results cover only a subset of enrolled participants.
The registry’s stated motivation concerns function and fall risk, but the primary result is an FSST measure rather than a reported fall outcome. A result on this test cannot be treated as a direct count of falls or as proof about longer-term fall risk. Likewise, the registry lists the DGI as a secondary outcome but does not provide an estimable two-arm comparison for that endpoint. Overall, the posted primary data give a limited descriptive account of one balance-related test at 12 weeks, without a reported analysis that quantifies uncertainty in the between-arm contrast.
9. Statistical Methods Explained
The registry record identifies the study as randomized and parallel. In a randomized study, assignment is intended to create comparison groups by chance rather than by participant or investigator choice. That design can support a fair comparison, but the value of the comparison depends on how assignment was carried out, how outcomes were collected, and how missing results were handled. The registry does not report the randomization sequence method, allocation concealment, or the details of outcome-assessor masking. The masking field says single, but who was masked is not reported in the registry record.
What the arm summaries describe
The primary outcome is recorded as a mean in seconds, with the full range as the dispersion summary. A mean gives the arithmetic average of the observed test times in an arm. A full range identifies the lowest and highest observed values; it communicates the spread of the recorded observations but is sensitive to extreme values and does not describe the shape of the entire distribution. It is distinct from a confidence interval. A confidence interval is a statistical range intended to express uncertainty about an estimated quantity under a specified method. No confidence interval for the arm contrast is reported in the registry record.
The posted arm summaries are 11.04 seconds for 3 participants in the balance exercise program, with a full range of 9.9 to 12.93 seconds, and 14.29 seconds for 4 participants in standard care, with a full range of 9.28 to 25.47 seconds. These summaries describe the participants with recorded endpoint results. They do not by themselves provide a standard error, a test statistic, or an estimate of the uncertainty around a difference between arms.
Why a comparative analysis matters
A randomized trial’s principal comparison is generally the contrast between outcomes in the assigned groups, interpreted with its uncertainty. An inferential analysis might report an estimated contrast and a confidence interval, or a test result under a stated statistical model. The registry record reports no analyses for the primary outcome and supplies no such contrast. Consequently, the arm means can be described, but the evidence does not quantify how compatible the observed results are with a range of possible underlying arm differences.
General statistical explanation: small groups make estimates imprecise because a small number of individual observations can noticeably affect the group summary. This is one reason uncertainty intervals are useful: they show the range of values reasonably compatible with the data and the analysis assumptions. They do not remove uncertainty, and they do not correct missing outcome data or design limitations. No interval for the primary comparison is reported in the registry record.
Distribution and model assumptions
General statistical explanation: analyses of continuous outcomes often rely on assumptions about how observations vary and how the treatment contrast is estimated. With very small samples, checking distributional assumptions is difficult, and a single unusual value can matter greatly. The standard-care full range extends from 9.28 to 25.47 seconds, while the exercise-arm range is 9.9 to 12.93 seconds. The registry does not report whether a model-based comparison was considered, whether assumptions were assessed, or whether a nonparametric method was used.
Over-dispersion is a general concern mainly for count outcomes when observed variation is greater than a model assumes. It is not the reported form of this primary endpoint, which is a time measurement summarized by a mean and full range. The record does not describe an over-dispersion analysis or a statistical model for the FSST.
Planning illustrations and observed results
General statistical explanation: sample-size planning asks how many participants would be needed under stated assumptions to detect a chosen effect with a specified chance of detection, while controlling a stated error rate. Such calculations depend on assumptions about the effect, variability, allocation, and analysis. The planning illustration described for this study uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of the observed effect. These are planning assumptions, not a report of the trial’s original design rationale. The registry does not report the trial’s own sample-size justification.
A planning illustration is not observed power. Observed power is not a substitute for an uncertainty interval around the results, and planning calculations do not change what the trial observed. No numerical planning sample sizes are stated in the registry record text described for the primary outcome, so no such values are repeated.
Other outcomes and multiplicity
The registry lists the Dynamic Gait Index as a secondary outcome, but does not report an estimable two-arm comparison for that endpoint. When a study examines multiple outcomes or multiple analyses, multiplicity can increase the chance of a false-positive result if each is tested without an appropriate strategy. The registry record does not report a multiplicity adjustment or a prespecified hierarchy among outcomes. Since no inferential analysis is posted for the primary endpoint, there is no reported set of primary p-values to interpret or adjustment method to evaluate.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the FSST as the primary outcome and the Dynamic Gait Index as a secondary outcome. It reports two outcome measures but provides no estimable two-arm comparison for the other endpoint. The registry record does not report whether the secondary outcome was analyzed, how outcomes were prioritized, or whether any multiplicity adjustment was planned or applied. Multiplicity matters when several outcomes or analyses are tested: without a prespecified approach, interpreting an isolated positive result can overstate the strength of evidence. In this record, no inferential primary analysis is posted, so there are no reported test results from which to assess an adjustment strategy.
Missing endpoint data are a central interpretive issue. For the balance exercise program, 2 participants were lost to follow-up and 2 did not complete the 12-week mobility testing that included the FSST. In standard care, 1 participant was lost to follow-up. The posted FSST results include 3 participants in the exercise arm and 4 in standard care. The record does not explain the specific reasons for incomplete testing, whether any imputation was used, or whether additional analyses assessed sensitivity to missing data.
General statistical explanation: missing outcomes can affect a comparison if the participants with observed results differ systematically from those without them. A complete-case summary describes participants with measured outcomes; it does not automatically represent everyone randomized. Different assumptions about missing outcomes can lead to different estimates, so the handling strategy and sensitivity analyses are important to evaluate. Those details are not reported in the registry record.
The intended analysis population is also not reported in the registry record. It is therefore not possible to determine from the posted summary whether the primary analysis was intended to follow assignment regardless of participation, to include only participants who completed the intervention, or to use another population definition. The small observed endpoint groups and absent analysis details limit assessment of both missing-data effects and the intended treatment comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Balance Exercise Program | 0 | 7 | 0.0% |
| Standard Care | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Balance Exercise Program | 0 of 7 |
| Standard Care | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Balance Exercise Program | 0 of 0 |
| Standard Care | 0 of 0 |
The registry reports no serious adverse events in either arm among the participants listed as at risk: 0 of 7 in the balance exercise program and 0 of 5 in standard care. It also reports no other adverse events in either group and no deaths. These figures are counts recorded in the registry, not evidence that the risk of an adverse event is zero.
The at-risk groups are small, and a study of this size has limited ability to characterize uncommon events. A zero count means no event of the listed type was reported for the stated group during the recorded period; it does not rule out events that were not observed, not collected, or not entered into the record. The registry does not report event definitions, the duration of safety follow-up, or additional details about how adverse events were assessed.
The serious-event summary should be read separately from the primary FSST result. It concerns reported safety events, while the FSST measures performance on a balance task. The absence of reported serious adverse events does not establish an effect on fall risk, and the primary endpoint summaries do not establish safety. The record lists no serious adverse-event terms and reports no deaths in either arm.
12. What the Result Does, and Does Not, Mean
The posted results describe the 12-week FSST performance recorded for a small subset of the enrolled trial participants. The reported mean is 11.04 seconds for the balance exercise program and 14.29 seconds for standard care. The full ranges are 9.9 to 12.93 seconds and 9.28 to 25.47 seconds, respectively. These are observed summaries, not a reported estimate of a treatment effect.
The registry does not report a statistical comparison, confidence interval, or p-value for the primary endpoint. Without a comparative estimate and its uncertainty, the observed arm summaries cannot establish whether any difference reflects a systematic contrast or random variation. The record also does not report the analysis method or the intended analysis population. The FSST results should therefore be interpreted as descriptive rather than as a quantified causal effect.
The study’s purpose refers to functional benefits and reduced fall risk, but the primary outcome is a timed balance test. It measures performance on a standardized stepping task; it is not itself a count of falls. The registry lists the DGI as a secondary outcome, but does not report an estimable two-arm comparison for it. The posted data therefore do not establish an effect on actual falls or on all dimensions of balance and mobility.
Nor do the reported results show what would happen in a larger or different population. With 3 and 4 participants contributing to the endpoint summaries, the group means and ranges may be sensitive to individual observations. Missing follow-up and incomplete mobility testing further limit what can be inferred about the randomized groups as a whole. These considerations do not negate the descriptive information; they define its scope.
The safety record reports no serious adverse events, other adverse events, or deaths in the listed groups. Given the small at-risk groups, those counts should not be read as proof that events cannot occur. Overall, the registry supplies limited descriptive endpoint and safety information, but not the comparative statistical evidence needed to make a precise statement about the intervention’s effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a randomized design and a reported randomized comparison. Random allocation can provide a strong basis for comparing groups when the outcome data and analysis are fully reported. In this record, however, the primary outcome is summarized by arm without a posted inferential contrast. The design label alone does not supply the missing estimate or quantify its uncertainty.
The endpoint summaries also illustrate why sample size and completeness matter. The study enrolled 12 participants, while the posted FSST results include 3 and 4 participants in the respective arms. The registry notes losses to follow-up and incomplete testing. When only a few observations contribute to a mean, individual values can have a substantial effect on the summary, and the range can help describe observed variation without resolving uncertainty about the arm contrast.
The distinction between a balance test and a clinical event is important. The FSST measures a timed functional task related to dynamic standing balance. It is relevant to the study’s stated interest in fall risk, but it is not a direct fall count. Statistical interpretation should stay aligned with the endpoint actually reported rather than extending a test result to outcomes that were not measured or analyzed in the posted record.
The record also highlights the need for transparent reporting of analysis populations, missing-data handling, and outcome multiplicity. Those details help readers understand who contributed to an analysis, how incomplete results were addressed, and how multiple outcomes were interpreted. They are not reported in the registry record. Planning assumptions can help illustrate what a future study might require, but they are not evidence that the completed trial had adequate power or that its observed summaries demonstrate an effect.
These features make the record useful for statistical reading: it offers concrete arm summaries, but also clear limits on the conclusions those summaries support.
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 primary endpoint summaries are based on 3 participants in the balance exercise program and 4 in standard care, despite total enrollment of 12. The endpoint record notes 2 exercise-arm participants lost to follow-up and 2 who did not complete the 12-week mobility testing that included the FSST; in standard care, 1 participant was lost to follow-up. The registry does not explain these missing results in detail or report an analysis addressing their potential effect.
No inferential comparison is posted for the primary outcome. The record gives arm means and full ranges but does not report a treatment contrast, confidence interval, p-value, or statistical method. It also does not report the intended analysis population. This prevents assessment of the estimated between-arm effect, its precision, and whether the analysis followed the original randomized assignments.
The registry identifies the trial as single-masked but does not say who was masked or describe the masking procedures. Details of random sequence generation and allocation concealment are also not reported in the registry record. Without these details, readers cannot fully evaluate how assignment and outcome assessment were protected from bias.
The FSST is a timed balance task, not a direct measurement of falls. The posted primary result therefore has a narrower scope than the study’s stated interest in fall risk. The DGI is listed as a secondary outcome, but no estimable two-arm comparison is available for it. The record does not report how outcomes were prioritized or whether multiplicity was addressed.
Finally, the registry does not report the trial’s own sample-size justification, detailed statistical plan, or sensitivity analyses. The small observed groups and missing analysis details limit precision and reproducibility. These limitations mean the results should be treated as descriptive evidence from this trial, not as a conclusive estimate of the intervention’s effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Metabolic Syndrome and Fall Risk — NCT02633891.
- Registry record last updated 2024-06-28; status last verified 2024-03.
- Results first posted 2024-06-28.
- 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.
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18. Record Summary
NCT02633891 is a completed randomized, single-masked parallel behavioral study sponsored by the VA Office of Research and Development. It enrolled 12 participants and compared a balance exercise program with standard care. The exercise program combined weekly group training with home balance practice; standard care consisted of weekly education about health and fall prevention without an exercise class.
The primary outcome was the Four Square Step Test at 12 weeks, measured in seconds. The posted mean was 11.04 seconds among 3 participants in the exercise arm and 14.29 seconds among 4 participants in standard care. Full ranges were 9.9 to 12.93 seconds and 9.28 to 25.47 seconds. The record notes incomplete follow-up and mobility testing and does not report an inferential comparison for the primary endpoint.
The Dynamic Gait Index is listed as a secondary outcome, but an estimable two-arm comparison is not reported. No serious adverse events, other adverse events, or deaths are recorded in either arm. The registry does not report the detailed statistical plan, analysis population, or missing-data methods.