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 Reducing Falls With RENEW in Older Adults Who Have Fallen (NCT01080196), a randomized na study. The primary outcome is The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01080196 |
| Phase | NA |
| Condition | Muscle Atrophy, Physical Deconditioning |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 134 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Utah |
| Results posted | Yes |
2. Clinical Question
Population
Older adults who have fallen. The registry record lists muscle atrophy and physical deconditioning among the conditions and describes the program as intended for older adults who have fallen. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
RENEW, a high-intensity resistance exercise approach using negative work, as part of a multicomponent exercise and fall-reduction program. The record describes exercise on a recumbent ergometer, with participants resisting pedal movement to produce eccentric contractions around the knee and hip.
Comparator
Traditional resistance exercise, described as lower-extremity exercise using isotonic weight machines and cuff weights as part of a multicomponent exercise fall-reduction program. Details of the progression are incomplete in the registry record.
Primary question
How did the groups compare on the mean number of days survived without a fall over the 12-month study duration? The posted outcome is a continuous measure reported as a mean, with standard errors for each arm. The registry record does not report a separate mediation analysis establishing whether muscle conditioning explains any effect on falls.
The trial description frames the comparison around muscle conditioning, falling risks, and fall incidence. The posted primary result addresses days survived without a fall, rather than reporting a direct measure of every one of those proposed pathways. The clinical question should therefore be read narrowly: it concerns the reported group means for this endpoint, not every aspect of the broader program or its proposed mechanisms.
The record identifies RENEW and traditional resistance exercise as the two strategies being compared, but both descriptions place exercise within a multicomponent fall-reduction program. The result is consequently about the contrast between the recorded study arms, not a comparison of exercise with no intervention.
3. Trial Design
The registry identifies this as a randomized, parallel-group trial with single masking. Enrollment is recorded as 134. The record lists 68 participants in RENEW and 66 in the traditional exercise arm for the primary outcome. The trial status is completed. Its recorded start is 2008-04, and primary completion is recorded as 2014-02.
The intervention is behavioral. RENEW is described as resistance exercise performed on a recumbent ergometer, where resisting pedal movement produces negative work and eccentric muscle contractions around the knee and hip. The traditional arm is described as lower-extremity resistance exercise using isotonic weight machines and cuff weights. Both descriptions place the exercise within a multicomponent exercise and fall-reduction program.
The arm descriptions in the registry record are incomplete, including the details of how the exercise programs progressed. The record does not specify which people were masked, how randomization was generated or concealed, or whether participants could be unaware of their assigned exercise. These design details are not reported in the registry record, so the single-masking label alone does not establish who was masked or how masking was maintained.
The trial is listed with phase NA. No placebo or no-exercise arm is listed in the posted results. The comparison is therefore between the two active exercise approaches as recorded, with the shared program context also relevant when interpreting what the result can say.
The brief description states that the investigators anticipated muscle conditioning would mediate effects on falling risks and fall incidence. That statement describes an anticipated relationship, not a reported finding. The registry record does not report a mediation analysis or provide results for the proposed pathway. The primary outcome result should not be taken as evidence that this mechanism was tested or confirmed.
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 | RENEW | TRADITIONAL |
|---|---|---|
| STARTED | 68 | 66 |
| COMPLETED | 68 | 66 |
| NOT COMPLETED | 0 | 0 |
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 | RENEW | TRADITIONAL | Total |
|---|---|---|---|---|
| Participants analysed | 68 | 66 | 134 | |
| Age, Continuous | years | 76.59 (SD 7.39) | 75.59 (SD 6.98) | 76.1 (SD 7.2) |
| Sex: Female, Male: Female | Participants | 45 | 42 | 87 |
| Sex: Female, Male: Male | Participants | 23 | 24 | 47 |
| Region of Enrollment: United States | participants | 68 | 66 | 134 |
6. Primary Endpoint
The registry lists the primary outcome as The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Days survived without a fall. |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the number of days survived without a fall over the 1 Year Duration of the Study, with a timeframe of 12 months. It is a continuous measure reported as a mean, and the registry lists its dispersion as the standard error. The endpoint expresses the amount of time participants were recorded as remaining alive without a fall during the study period. The operational definition, including how deaths or incomplete follow-up were handled, is not reported in the registry record.
This endpoint is used to represent fall-free time rather than simply recording whether a participant ever fell. In general, a measure of time without an event can retain information about when an event occurs, whereas a simple event indicator does not distinguish earlier from later events. The posted registry result, however, is a group mean for days survived without a fall; it does not provide individual event histories or a time-to-event analysis.
The reported RENEW mean is 239.0 days, with a standard error of 18.0. The traditional exercise mean is 249.7 days, with a standard error of 16.38. These values describe the posted endpoint summaries; they do not by themselves establish why participants had the observed amount of fall-free time. The result also does not separately report fall severity, number of falls, or the other outcomes named in the trial description.
Because the measure concerns both survival and falls, its interpretation depends on how the registry defines a day as free of a fall and handles follow-up. Those details are not reported in the registry record. The endpoint is therefore best understood as the named registry measure, without assuming additional rules for event counting or censoring.
7. Results Posted in the Registry
- TRADITIONAL: mean 249.67 versus 239.00 on control; difference 10.67 (95% CI -37.03 to 58.37), standardized effect d = 0.08; z-test p = 0.661.
Mean difference: TRADITIONAL
95% CI: -37.03 to 58.37
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted mean was 239.0 days in the RENEW arm and 249.7 days in the traditional exercise arm. The reported mean difference, expressed as traditional exercise minus RENEW, is 10.67 days. The 95% confidence interval is -37.03 to 58.37, and the reported unadjusted p-value is 0.661.
The point estimate is in the direction of a higher mean in the traditional exercise arm, but the confidence interval extends across zero. It is compatible with a difference favoring either arm, as well as little or no difference. The interval is wide relative to the point estimate, so the registry result does not pin down the direction or size of the group contrast precisely. The p-value likewise does not establish that the groups differ. Neither statistic demonstrates that the treatments are equivalent.
The trial enrolled 134 participants, with primary outcome results listed for 68 in RENEW and 66 in the traditional exercise arm. A modest observed contrast in a trial of this size can be estimated imprecisely, especially when the endpoint varies substantially among participants. The pooled standard deviation listed for the contrast is 141.1 days, which gives context for the uncertainty in the group comparison, but does not explain the source of that variability.
These results concern only the posted primary endpoint and the reported comparison. The trial description also mentions muscle conditioning, falling risks, and fall incidence, but the registry record does not provide posted secondary outcome results for those measures. The result therefore cannot be extended to claim that the proposed mechanisms or other fall-related outcomes changed in a particular way.
The interpretation also depends on the completeness of outcome measurement and analysis. The registry record does not report how missing endpoint data were handled, the analysis population, or the full statistical plan. It is not possible to determine from the posted record whether the displayed comparison accounts for baseline characteristics or other covariates. The reported estimate should be read as the registry's stated group contrast, not as a fully documented causal analysis.
In general, a non-small p-value is not proof of no effect, and an interval crossing zero is not proof that the true difference is exactly zero. Here, the central estimate is relatively small compared with the range of values compatible with the confidence interval, leaving substantial uncertainty about the contrast. The registry results do not establish that one approach is superior, that the approaches are equivalent, or that either approach changes fall risk.
9. Statistical Methods Explained
The primary outcome is continuous and is summarized as a mean for each arm. The comparison is reported as a mean difference, with traditional exercise minus RENEW as the direction of subtraction. The contrast is 10.67 days, based on group means of 249.7 and 239.0 days, respectively. A positive value therefore corresponds to a higher reported mean for traditional exercise on this endpoint.
What does a mean describe?
A mean is the arithmetic average of the observed values in a group. It provides a compact description of the group's central level, but it does not show the distribution of participant outcomes. Two groups can have similar means while their individual values vary widely or have different shapes. The registry record does not provide individual observations or a distributional description for this endpoint, so the mean alone cannot show how many participants had particular amounts of fall-free time.
The standard errors listed for the group means are 18.0 for RENEW and 16.38 for traditional exercise. In general, a standard error describes the uncertainty in an estimated quantity, such as a sample mean, rather than the spread of individual participant outcomes. The record labels these values as standard errors, so they should not be interpreted as standard deviations. The pooled standard deviation listed for the group comparison is 141.1 days and describes a different aspect of variability used in the displayed comparison and planning illustration.
How should the mean difference be read?
A mean difference places the two group means on the original measurement scale. Here, that scale is days survived without a fall. The reported estimate is 10.67 days, with traditional exercise as the first group in the subtraction. It is an estimate from the observed trial data, not a guaranteed difference for other participants or settings. The estimate does not state how any individual participant's outcome would change under one exercise approach rather than the other.
The confidence interval for the mean difference is -37.03 to 58.37. In general, a confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. It provides a range of values reasonably compatible with the data and method; it is not a range containing a known proportion of individual outcomes. When an interval includes zero for a difference, values representing either direction and no difference remain compatible with the data. The interval is broad enough that the observed point estimate should not be treated as precise evidence of a particular direction.
What does the p-value add?
The reported unadjusted p-value is 0.661. In general, a p-value assesses how unusual data at least as inconsistent with a specified null model would be if that model were true and the analysis assumptions held. It is not the probability that the null hypothesis is true, nor does it measure the probability that the observed estimate is due to chance. A p-value does not describe the size or clinical importance of a difference. The confidence interval is useful alongside it because it makes the range of compatible effects more visible.
The term unadjusted indicates that this reported p-value is not presented as adjusted for other comparisons or covariates. The registry record does not report a broader analysis plan that would establish which analyses were prespecified, whether adjustment was planned, or how this result fits into any family of outcomes. The p-value should therefore be interpreted as the reported comparison, without assuming a particular multiplicity strategy.
Why can variability matter?
In general, greater variation among participant outcomes makes a group mean difference harder to estimate precisely unless the amount of information also increases. Over-dispersion is a concept used when variability is greater than a statistical model expects; it can make standard errors and tests unreliable if the model does not account for it. The posted endpoint is continuous, and the registry record does not report a model diagnostic or an over-dispersion assessment. It would be inappropriate to claim that over-dispersion was present or that a particular correction was used.
The pooled standard deviation is relevant to the planning illustration, which uses the observed effect and a normal approximation. The planning assumptions specify two-sided significance level 0.05 and equal allocation between arms. These are assumptions for an illustrative calculation, not a statement of the original trial's design. The trial's own sample-size justification and statistical plan are not reported in the registry record.
The trial is described as randomized, parallel, and single masked. Random allocation is intended in general to reduce systematic differences between groups at assignment, while a parallel design keeps participants in their assigned group rather than crossing them between treatments. The label single masked does not identify who was masked; that information is not reported in the registry record. Details about allocation procedures, adherence, covariate adjustment, and analysis population are also not reported. These omissions limit how completely the posted estimate can be evaluated as an analysis of the randomized comparison.
10. Confidence Intervals and Precision
The estimated mean difference is 10.67 days, with a 95% confidence interval from -37.03 to 58.37. This interval is wide and includes zero. The data are therefore compatible with a mean difference in either direction, as well as with little or no difference. The point estimate alone gives an incomplete account of uncertainty; the interval shows that the magnitude and direction are not estimated precisely.
In general, a confidence interval reflects both the estimate and its uncertainty under the statistical method used. It does not mean that the true value has a 95% probability of lying within this particular interval. Rather, the stated confidence level describes the long-run behavior of intervals produced by the method under its assumptions. The registry record does not provide enough detail about the model or analysis population to assess all of those assumptions independently.
The reported standard errors are 18.0 days for RENEW and 16.38 days for traditional exercise. These quantify uncertainty in the reported means, not the range of individual participant results. The pooled standard deviation of 141.1 days indicates substantial variability in the endpoint relative to the observed contrast, but the registry does not provide individual data or a fuller distribution to characterize that variation.
The interval should not be read as proof of equivalence. Equivalence requires a prespecified margin and a design and analysis intended to assess whether the uncertainty is confined within that margin. Such a margin and an equivalence analysis are not reported in the registry record. The posted result is an imprecise estimate of the group difference, rather than a definitive demonstration of either no difference or a meaningful advantage for either arm.
11. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 2,745 | 3,674 |
| 75% of the observed effect | 4,879 | 6,532 |
| 50% of the observed effect | 10,977 | 14,696 |
The sample-size estimates are planning illustrations based on the observed effect, not the trial's original design calculations. For this continuous outcome, the figures are participants per arm, rather than total events. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The planning effect is set to the stated fraction of the observed effect. The trial's original sample-size assumptions are not reported in the registry record.
The 80% power column gives the estimated participants per arm for a future study to have an 80% chance of detecting the selected effect under the planning assumptions, if that effect is the true one and the assumptions hold. The 90% power column uses a higher target chance of detecting that effect, and therefore gives larger participant requirements. These are prospective planning quantities, not descriptions of what happened in this completed trial.
The planning scenarios use 100%, 75%, and 50% of the observed effect. Planning for 75% of the observed effect or 50% of the observed effect represents targeting a smaller difference than the full observed estimate. Smaller effects are harder to distinguish from random variation, so they require more participants under the same assumptions. The listed estimates increase accordingly as the targeted fraction gets smaller.
Because the observed difference is uncertain, basing a future design directly on it may be unstable: an observed effect can be smaller or larger than the underlying effect. These figures are illustrations, not a recommended design or a justification for the original enrollment. The registry record does not report the original sample-size rationale. This is not observed power; it is a planning exercise using the observed effect as an input.
12. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.
Worked calculation for this trial
- Observed difference Δ = 10.670; pooled standard deviation σ = 141.077.
- n = 2 × (1.96 + 0.842)2 × 141.0772 / 10.6702 = 2,744.2, rounded up to 2,745 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
delta <- 10.67 # observed difference in means
sigma <- 141.077291194966 # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")
# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1080196)
n <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n)) # difference in sample means
s2 <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1)) # pooled sample variance
tstat <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))
Output from running the code
100% of observed effect: n per arm = 2,745 (80% power), 3,674 (90% power)
75% of observed effect: n per arm = 4,879 (80% power), 6,532 (90% power)
50% of observed effect: n per arm = 10,977 (80% power), 14,696 (90% power)
power.t.test: 2745.2
Simulated power at n = 2,745 per arm: 0.803 (20000 replicates)The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
13. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures, but no secondary outcome results are posted. The primary outcome is reported, while the posted record does not show results for the other measures. Their definitions, analysis results, and relationship to any prespecified hierarchy are not reported in the registry record. The trial description mentions muscle conditioning, falling risks, and fall incidence, but those statements do not supply results for these outcomes.
Multiplicity arises when more than one hypothesis or outcome is tested. In general, conducting many tests can increase the chance of at least one apparently unusual result, so a statistical plan may specify how to interpret or adjust across comparisons. The registry record does not report whether multiplicity adjustments were planned or used, or whether the primary outcome was the sole confirmatory analysis. The reported p-value is unadjusted. Without a fuller analysis plan, the effect of other planned comparisons on interpretation cannot be assessed.
Missing-data handling is also not reported in the registry record. The posted primary outcome summaries include 68 RENEW participants and 66 traditional exercise participants, while total enrollment is recorded as 134. The record does not explain whether every enrolled participant contributed an endpoint value, how unavailable observations were handled, or whether sensitivity analyses were conducted. It also does not specify whether the primary analysis followed assignment regardless of adherence or used another analysis population.
These details matter because missing outcomes and choices about analysis population can affect the estimate and its uncertainty. In general, analysis according to randomized assignment preserves the original group comparison, while analyses restricted by adherence or outcome availability can introduce differences between the analyzed groups. This is a general methodological point, not a claim about what occurred in this trial. The registry record does not report enough information to identify the approach used.
The record identifies randomization and single masking, but does not give the statistical analysis plan, any interim analysis information, or the precise analysis population. Those elements should not be inferred from the presence of a posted result. Consequently, the result can be described as reported, but the registry alone does not allow a full assessment of prespecification, missingness, or the multiplicity strategy.
14. 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 |
|---|---|---|---|
| RENEW | 0 | 68 | 0.0% |
| TRADITIONAL | 0 | 66 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RENEW | 4 of 68 |
| TRADITIONAL | 3 of 66 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RENEW | TRADITIONAL |
|---|---|---|---|
| joint and muscle pain | Musculoskeletal and connective tissue disorders | 4 of 68 | 3 of 66 |
The registry lists zero participants affected by serious adverse events among 68 participants at risk in the RENEW arm and zero among 66 at risk in the traditional exercise arm. No serious adverse event terms are listed. These figures describe the serious adverse events recorded in the registry; they do not establish that no serious events could have occurred outside the recorded information or that the arms have identical safety profiles.
For other adverse events, the record lists 4 affected participants among 68 at risk in RENEW and 3 among 66 at risk in traditional exercise. These are the posted affected-participant counts, not a comparison adjusted for follow-up or other factors. The registry record does not report the specific other adverse event terms in the information available for these results, their severity, or the timing and duration of events.
Deaths are not reported in the registry record. The adverse-event figures should be interpreted as descriptive registry counts. They do not establish a causal difference between arms, and they do not support a broad conclusion about safety beyond the recorded event information.
15. What the Result Does, and Does Not, Mean
The posted primary result is an estimated mean difference of 10.67 days in days survived without a fall, with the traditional exercise mean higher than the RENEW mean. The confidence interval, -37.03 to 58.37, includes values in either direction and zero. The result is therefore uncertain about both the direction and size of the underlying group difference. The unadjusted p-value of 0.661 does not provide evidence that the groups differ on this endpoint.
This does not prove that the approaches have the same effect. A failure to establish a difference is not the same as demonstrating equivalence, especially when the confidence interval remains compatible with effects in either direction. Equivalence would require a prespecified margin and an analysis designed for that question; these are not reported in the registry record.
The endpoint result also does not answer every question raised in the trial description. The description refers to muscle conditioning, falling risks, and fall incidence, and anticipates that muscle conditioning may mediate effects. No secondary results or mediation analysis are posted in the registry record. The primary outcome should not be used to infer whether muscle conditioning changed or whether a proposed mechanism was confirmed.
Both arms are described as exercise interventions delivered within a multicomponent exercise and fall-reduction program. The posted comparison is not an estimate of the effect of participating in such a program versus receiving no program. It is a comparison between the recorded RENEW and traditional resistance exercise arms, with incomplete details about the program components and progression.
The finding is limited to the recorded endpoint, population, and study context. Participant characteristics beyond the description of older adults who have fallen are not reported in the registry record. The record also does not provide sufficient detail about missing data, analysis populations, or the statistical plan to resolve all questions about how the estimate was produced. No medical or treatment recommendation follows from this statistical interpretation.
16. Why This Trial Matters Statistically
This trial illustrates why an estimated effect should be read together with its uncertainty. The point estimate of 10.67 days gives a concise description of the observed contrast, but the confidence interval from -37.03 to 58.37 shows that a broad range of effects remains compatible with the data. Reporting the estimate without the interval could make the result seem more definite than it is.
It also illustrates the distinction between not detecting a difference and demonstrating that two approaches are equivalent. The interval crosses zero, and the unadjusted p-value is 0.661, but these registry entries do not establish that the true difference is exactly zero. To support equivalence, investigators would need a suitable prespecified margin and an analysis designed around that question; this information is not reported in the registry record.
Outcome choice is another statistical issue. Days survived without a fall is a continuous summary of fall-free time, while the trial description also refers to fall incidence, falling risks, and muscle conditioning. Those outcomes represent related but distinct questions. The posted primary result cannot stand in for unreported results on the other measures, nor can it establish the proposed mediating role of muscle conditioning.
Finally, the planning illustrations show how sample-size needs depend on the effect a future study aims to detect. Smaller targeted effects require more participants under the stated assumptions. Because the observed effect is uncertain, planning from it is illustrative rather than definitive. The registry record does not report the original design assumptions, so the planning figures should not be mistaken for the rationale behind this trial's enrollment.
17. 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 registry record offers a limited account of trial procedures and analysis. The arm descriptions are incomplete, especially regarding program progression, and the detailed eligibility criteria and participant characteristics are not reported. The single-masking label does not identify who was masked. Randomization procedures, allocation concealment, adherence, and the handling of deviations from assigned exercise are also not reported in the registry record.
The primary outcome is described as days survived without a fall over 12 months, but operational details are absent. The record does not specify how a fall was defined and ascertained, whether all falls or only the first fall informed the measure, how death was handled, or what happened when follow-up was incomplete. Deaths are not reported in the adverse-event information. These gaps limit interpretation of the outcome's exact construction.
The displayed arm summaries and comparison do not include individual data or a detailed statistical analysis plan. Missing-data methods, analysis populations, covariate adjustment, model diagnostics, and interim analyses are not reported in the registry record. The record also does not explain the relationship between the five listed outcome measures and the absence of posted secondary results. These omissions prevent a full assessment of prespecification and robustness.
The primary comparison has a wide confidence interval, which leaves substantial uncertainty about the size and direction of the difference. The enrollment and planning estimates do not by themselves explain why the interval has this width, and the original sample-size justification is not reported. These limitations are specific to what the registry record documents; they do not establish that a particular procedure was or was not performed outside the record.
18. Related Tutorials
19. Related Statistical Calculators
20. Sources
- ClinicalTrials.gov: Reducing Falls With RENEW in Older Adults Who Have Fallen — NCT01080196.
- Registry record last updated 2022-06-21; status last verified 2022-05.
- Results first posted 2018-01-10.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
21. Record Summary
NCT01080196 is a completed, randomized, parallel-group trial with single masking, sponsored by the University of Utah. Enrollment is recorded as 134. The study compared RENEW with traditional resistance exercise among older adults who have fallen, with both interventions described in the context of a multicomponent exercise and fall-reduction program.
The primary endpoint was mean days survived without a fall over 12 months. The posted means were 239.0 days for RENEW and 249.7 days for traditional exercise. The reported mean difference was 10.67 days, with a 95% confidence interval of -37.03 to 58.37 and an unadjusted p-value of 0.661. The interval reflects substantial uncertainty and includes zero.
Secondary outcome results, missing-data methods, analysis populations, and the original sample-size justification are not reported in the registry record. The planning estimates are illustrations based on the observed effect, not the original design rationale.