Time Course Adaptations Using Deuterated Creatine (D3Cr) Method: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Time Course Adaptations Using Deuterated Creatine (D3Cr) Method (NCT03573583), a randomized na study. The primary outcome is Muscle Mass.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, parallel-group pilot study. The registry record gives an enrollment of 21 and a status of completed. It lists the condition as sarcopenia and names the University of Florida as sponsor. The study began on 2019-02-01, and the primary completion date was 2020-08-01. The phase is listed as NA.

The two behavioral interventions were Resistance Training and Successful Aging. The resistance-training description specifies full-body sessions three days per week, with intensity, volume, tempo, and progression based on Federal Physical Activity guidelines. The Successful Aging group was scheduled for stretching and health education classes every 2-5 weeks, up to 7 total visits. Details on how masking was implemented, which people were masked, adherence, and intervention fidelity are not reported in the registry record.

The primary outcome is a continuous measure: change in muscle mass measured by D3Cr, in Kg, at baseline and week 16. The posted arm summaries report a mean and standard deviation for each group. The registry also lists Appendicular Lean Mass, Lean Body Mass, and correlation between changes in muscle mass as secondary outcomes. Numerical results are posted for the first two; results for the correlation outcome are not reported in the registry record.

The registry does not report the trial’s original sample-size justification, its detailed statistical analysis plan, or analysis-population definitions. The planning illustrations accompanying the posted results are calculations based on the observed effect and are distinct from the original design rationale.

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: A total of 54 participants were assessed for eligibilty and 33 were excluded ( 23 not meeting inclusion criteria (18 SPPB out of range) and 10 withdrew pre-randomization). Twenty-one participants met eligibility criteria and were subsequently randomized into 2 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 Muscle Mass, measured over Baseline and week 16.

The primary endpoint is change in muscle mass measured using the Deuterated Creatine (D3Cr) method, expressed in Kg, from baseline to week 16. The registry describes the outcome as a continuous measure and reports group means with standard deviations. The posted means are 3.47 for the Resistance Training group and 1.19 for Successful Aging. These are group-level summaries of change, not individual responses.

The study’s stated purpose is to assess the feasibility of using D3Cr to measure muscle mass and to understand the role of muscle mass in functional outcomes in older adults. Thus, the endpoint is relevant to the measurement-method focus as well as to the intervention comparison. The registry record does not provide details about the measurement procedure, its repeatability, or the criteria used to judge feasibility. It also does not report a primary outcome for functional performance in the results presented.

In general, measuring change between baseline and a later assessment can describe how a continuous outcome shifted over the observation period. Comparing average changes between groups addresses whether their reported changes differ on average. Such a comparison does not, by itself, establish why a difference occurred or show how representative the result would be in other populations. The registry’s sponsor analysis is reported as an ANCOVA comparison of final values, which is a different statistical summary from the unadjusted comparison of mean changes.

7. Results Posted in the Registry

• Successful Aging: mean 1.19 versus 3.47 on control; difference -2.28 (95% CI -3.88 to -0.68), standardized effect d = -1.23; z-test p = 0.005.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Appendicular Lean Mass (ALM)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Successful Aging: mean -0.23 versus 0.81 on control; difference -1.04 (95% CI -1.63 to -0.45), standardized effect d = -1.51; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Successful Aging than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Lean Body Mass (LBM)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Successful Aging: mean -0.19 versus 1.10 on control; difference -1.29 (95% CI -2.34 to -0.24), standardized effect d = -1.08; z-test p = 0.016.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Successful Aging than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary results provide a broadly similar direction of group averages to the primary result for the two outcomes with numerical values posted: Appendicular Lean Mass and Lean Body Mass. In both, the reported mean changes are higher in the Resistance Training group than in Successful Aging. This directional pattern is consistent with the primary muscle-mass summaries, but it does not make the secondary measures interchangeable with the primary D3Cr endpoint. They are distinct measures and may reflect different aspects of body composition.

The registry lists correlation between changes in muscle mass as another secondary outcome, but its numerical result is not reported in the registry record. The available secondary findings therefore do not support a complete account of all listed secondary outcomes. The registry reports 3 secondary outcomes posted, and the correlation result is not included among the numerical summaries described.

The sponsor’s ANCOVA results for the secondary measures do not have identical statistical evidence: the registry reports p = 0.009 for Appendicular Lean Mass and p = 0.07 for Lean Body Mass. These values should be considered alongside the estimates and intervals, not as a ranking of which outcome matters most. The registry record does not report a prespecified hierarchy among secondary outcomes or a multiplicity-adjustment procedure.

In general, when several outcomes are examined, the chance of observing at least one apparently notable result can increase if no adjustment or interpretive hierarchy is used. That general issue means unadjusted secondary findings carry less weight than a clearly prespecified primary analysis. It does not erase their descriptive value, but it limits how confidently they can be treated as confirmatory evidence. The results are also from a small pilot, and the registry does not describe whether these secondary analyses were planned before data were examined.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Appendicular Lean Mass (ALM)
• Lean Body Mass (LBM)
• Correlation Between Changes in Muscle Mass

9. Statistical Interpretation

10. Statistical Methods Explained

The outcomes in this study are continuous measures summarized by group means and standard deviations. A mean describes the average value in a group; a standard deviation describes how spread out the individual values are around that average. In general, the standard deviation is not the uncertainty interval for the mean or for a group difference. The registry gives no participant-level observations, so the reported summaries cannot show the full distribution of values or identify unusual observations.

What does the unadjusted comparison represent?

The recalculated primary contrast is a simple, unadjusted comparison of the posted summary statistics. It reports Successful Aging minus Resistance Training, giving a mean difference of -2.28. Its interval runs from -3.88 to -0.680, and its unadjusted p-value is 0.005. The sign depends on the order of subtraction; it should be read together with the group means. With the stated order, a negative estimate means the posted mean change was lower for Successful Aging than for Resistance Training.

This re-calculation is not the sponsor’s model-based result. It does not adjust for baseline values or other covariates. The registry identifies the sponsor’s method as ANCOVA but does not report the covariates, model details, or analysis population. The sponsor reports a mean difference in final values of 2.29, with a 95% confidence interval from 0.22 to 4.36 and p = 0.03. That contrast is oriented in the reverse direction from the recalculated contrast and addresses final values under the reported ANCOVA method, rather than the difference between the posted mean changes.

How should a p-value be understood?

In general, a p-value describes how incompatible the observed data are with a specified null model, under the assumptions used for the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a difference. The p-values in the registry should be interpreted alongside the estimated differences and their intervals. The registry does not report the full hypothesis-testing plan, including whether the primary test was prespecified in the same form as the posted analysis.

The recalculated p-value is explicitly unadjusted. The registry does not report a multiplicity adjustment for the secondary outcomes, nor does it state whether any planned tests were selected from a larger set. Consequently, a reader should not interpret isolated secondary p-values as if they had been protected against the possibility of multiple testing. The sponsor’s reported p-values are part of the registry’s analysis record; the adjustment details beyond the stated ANCOVA method are not reported.

What does ANCOVA contribute?

In general, analysis of covariance (ANCOVA) compares outcome values while accounting for one or more covariates. Depending on the specified model, this can make a comparison more precise or account for measured baseline differences. Those are general properties, not claims about the exact model used in this trial. Although the registry labels the sponsor analysis ANCOVA, the covariates, model specification, assumptions, and handling of missing observations are not reported in the registry record. It is therefore not possible to reconstruct or assess the sponsor’s adjustment from the available summary.

The sponsor’s reported comparison and the recalculation use different summaries and contrast directions. The first is the sponsor’s ANCOVA mean difference in final values; the second is an unadjusted re-calculation from posted change means and standard deviations. Their numeric estimates need not match because they do not describe precisely the same estimand or analysis. The registry record does not identify a discrepancy between them. When an official sponsor analysis is reported, it should be distinguished from a simple re-calculation rather than presented as though the two methods were the same.

Why do randomization and masking matter?

In general, random allocation is intended to reduce systematic differences between groups at the point of assignment, while masking can reduce some forms of influence on care, measurement, or assessment. This study is recorded as randomized and single-masked, but the registry does not identify who was masked or describe the allocation procedure. With a small pilot enrollment, chance differences between groups may remain despite randomization. The record does not give enough detail to assess those differences or determine how masking was maintained.

The registry identifies a parallel design, meaning the groups were assigned to separate interventions rather than described as crossing over between them. It does not report an analysis plan for repeated measurements, adherence, or deviations from the assigned interventions. The reported endpoint timeframe is baseline and week 16; the registry entries do not establish how incomplete follow-up or missing measurements were handled.

What do the planning calculations mean?

In general, power is the probability that a planned statistical test will reject its null hypothesis under a particular assumed effect and analysis model. The planning illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Their rows consider stated fractions of the observed effect, and the columns describe participants per arm for 80% or 90% power. These calculations are planning illustrations, not a report of the trial’s original design assumptions. The original sample-size justification is not reported in the registry record.

The illustrative estimates depend on the observed effect, which is uncertain in a small pilot. In general, planning for a smaller effect requires more participants to achieve the same target power, all else held fixed. The calculations do not show that the trial had any particular power after completion, and no statement about observed power is warranted. The registry record does not report whether the trial used interim analyses or other monitoring rules.

11. Confidence Intervals and Precision

The primary sponsor analysis reports a 95% confidence interval from 0.22 to 4.36 for its mean difference in final values. The interval is centered on an estimate of 2.29 and is expressed in the sponsor’s contrast direction, with Resistance Training higher than Successful Aging. The interval does not describe every possible individual response; it quantifies uncertainty in the estimated group comparison under the analysis used.

The unadjusted re-calculation gives a mean difference of -2.28, with an interval from -3.88 to -0.680, using the contrast Successful Aging minus Resistance Training. The registry record does not state the confidence level for this recalculated interval, so no confidence level should be attached to it. Its signs are consistent with the stated group order and the posted mean changes. It is not the same estimate as the sponsor’s ANCOVA result.

In general, a confidence interval represents a range of values compatible with the observed data under a specified statistical method. A narrower interval indicates greater precision for that method, while a wider interval indicates more uncertainty. An interval does not account automatically for every source of bias, missing data, model misspecification, or selective reporting. The registry does not provide enough analysis detail to assess all such sources for the sponsor’s model.

The outcome groups are small, with posted outcome counts of 10 for Resistance Training and 11 for Successful Aging. The interval estimates therefore need to be read in the context of a pilot study, rather than as highly precise estimates of a stable effect. The record does not report a target precision, a minimal important difference, or an uncertainty threshold for the primary endpoint. No conclusion about whether the interval is clinically important can be drawn from the registry information alone.

12. 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.

The planning illustrations report participants per arm, not total events. This is a continuous-outcome setting, and the sample-size figures are expressed as participants per arm for 80% power and participants per arm for 90% power. The rows show planning for the full observed effect, 75% of the observed effect, and 50% of the observed effect. The curve should be read as an illustration of how the estimated requirement changes with the effect size being planned for, not as a record of actual enrollment requirements.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. These are planning assumptions for the illustration; the registry record does not report the trial’s original sample-size assumptions or justification.

In general, the 80% power column gives the estimated participants per arm under which the planned test would have an 80% chance of detecting the assumed effect, if the assumptions hold. The 90% power column gives the corresponding planning target for a 90% chance. Power is tied to a specified effect, significance level, design, and analysis; it does not guarantee that a particular study will detect an effect.

Smaller assumed effects require more participants to attain the same power target, all else equal. The planning values are based on an effect estimated from this pilot, so they are sensitive to uncertainty in that estimate and should not be treated as a definitive target for another study. These calculations are not observed power.

13. 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 z_1−α/2 = 1.960) and the desired power (z_1−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

1. Observed difference Δ = -2.280; pooled standard deviation σ = 1.853.
2. n = 2 × (1.96 + 0.842)² × 1.853² / -2.280² = 10.4, rounded up to 11 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 <- -2.28                      # observed difference in means
sigma <- 1.85331708310432                     # 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(3573583)
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 = 11 (80% power), 14 (90% power)
 75% of observed effect: n per arm = 19 (80% power), 25 (90% power)
 50% of observed effect: n per arm = 42 (80% power), 56 (90% power)
power.t.test: 11.4 
Simulated power at n = 11 per arm: 0.783 (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.

14. Analyses Reported by the Sponsor

The sponsor’s reported primary analysis is ANCOVA of final values. It gives a mean difference of 2.29, a 95% confidence interval from 0.22 to 4.36, and p = 0.03. The reported contrast is oriented so that a positive estimate corresponds to a higher final value in Resistance Training than in Successful Aging. The registry does not report the covariates or other model details used for this analysis.

The accompanying re-calculation is an unadjusted comparison of the posted mean changes. It subtracts Resistance Training from Successful Aging and reports -2.28, with an interval from -3.88 to -0.680 and p = 0.005. This is not a reproduction of the ANCOVA model: it uses change summaries, does not adjust for covariates, and uses the opposite contrast direction. The two estimates therefore should not be compared as though they were results from one identical calculation.

The registry record does not flag a discrepancy. The sponsor analysis is the study’s reported model-based result, while the recalculation is a straightforward comparison from posted summary statistics. Both point in the same general direction once their contrast orders are taken into account, but the sponsor result should be identified as the sponsor’s analysis and not replaced by the recalculated estimate. The registry does not provide enough detail to independently reproduce the ANCOVA result.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary outcome and lists secondary outcomes, but it does not report a multiplicity strategy. It does not say whether secondary tests were adjusted, whether a hierarchy of hypotheses was prespecified, or whether the analyses were intended to be confirmatory or exploratory. In general, testing several outcomes without an adjustment or testing hierarchy can increase the possibility of a nominally notable result arising by chance. For that reason, secondary p-values should be read as descriptive evidence unless a prespecified inferential strategy is documented.

The posted secondary findings include results for Appendicular Lean Mass and Lean Body Mass. A correlation between changes in muscle mass is also listed as a secondary outcome, but its result is not reported in the registry record. The record does not explain whether that outcome was not analyzed, was analyzed but not posted, or was unavailable for another reason; no explanation should be inferred.

Missing-data handling is not reported in the registry record. The record does not specify how missing outcome measurements, withdrawal, or incomplete follow-up were treated, nor does it provide imputation methods or sensitivity analyses. It also does not state whether the analyses followed intention-to-treat, per-protocol, or another analysis-population definition. The reported outcome counts and adverse-event at-risk counts are not identical in every group and category, but the record does not explain the differences. They should be reported as given rather than reconciled by assumption.

The registry’s description of randomization and single masking does not substitute for details about the analysis population or missingness. In general, the treatment of missing data can affect estimates if missingness is related to outcomes or group assignment. Without the reasons for missingness and the analysis methods, the potential impact cannot be assessed from this record. The original statistical analysis plan, interim-analysis plan, and any rules governing multiple looks at the data are not reported in the registry record.

16. 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 5% reporting threshold.

The adverse-event record reports zero serious adverse events for the Resistance Training group, with 10 at risk, and zero for Successful Aging, with 10 at risk. For other adverse events, it reports zero in Resistance Training, with 10 at risk, and zero in Successful Aging, with 11 at risk. Deaths are recorded as zero in each group. The registry lists no top serious adverse-event terms.

These are event counts and at-risk counts as recorded for the respective categories. The difference in the recorded at-risk counts between the Successful Aging serious-event and other-event entries should not be silently reconciled; the registry does not explain it. The figures describe what was recorded during the study, not the full range of possible events or future risk.

The registry does not report detailed adverse-event definitions, collection procedures, severity grading, relatedness assessment, or the duration of safety follow-up. With a pilot study of this size, zero recorded events does not establish that an intervention has no safety risks. It means only that the registry’s adverse-event results report zero events in the stated categories.

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

The posted results describe a randomized pilot comparison of resistance training with stretching and health education classes in older adults, with muscle-mass change measured using D3Cr from baseline to week 16. The mean change in the Resistance Training group was 3.47, compared with 1.19 in Successful Aging. The sponsor’s ANCOVA reports a higher final-value result in the Resistance Training group, with a mean difference of 2.29 and a 95% confidence interval from 0.22 to 4.36. The unadjusted re-calculation of mean changes also points in the same general direction when its contrast order is taken into account.

These findings do not establish that resistance training caused the observed difference, nor do they establish that the same estimate would be seen in a larger or different population. Randomization is a design feature, but the small pilot size, limited reporting on analysis details, and absence of participant-level data constrain interpretation. The registry does not report detailed eligibility criteria, adherence, missing-data methods, or the covariates in the sponsor’s ANCOVA.

The study’s stated purpose includes assessing the feasibility of the D3Cr method. The registry record does not provide feasibility criteria or detailed measurement-performance results, so the posted efficacy-style comparison alone cannot answer every question about feasibility. The record also does not provide numerical results for the listed correlation between changes in muscle mass.

The secondary outcome pattern is descriptively aligned with the primary mean-change pattern, but these findings carry less weight when a multiplicity plan is not reported. The adverse-event record shows zero events in the listed categories, but the small study and limited safety-reporting detail do not support a broad conclusion about safety. Overall, the results are a small-study statistical signal and a record of the comparisons reported, not medical advice or a definitive assessment of treatment effects.

18. Why This Trial Matters Statistically

This trial is statistically notable because it centers on a measurement method as well as an intervention comparison. The study’s stated purpose is to assess the feasibility of the Deuterated Creatine method for measuring muscle mass and to understand the role of muscle mass in functional outcomes in older adults. This makes the distinction between measurement questions and treatment-effect questions important: an observed difference in an outcome does not, by itself, establish the performance or feasibility of the measurement method.

The record also illustrates why analysts should distinguish a sponsor’s model-based result from a simple recalculation using posted summaries. The sponsor reports ANCOVA on final values, while the recalculation compares mean changes without adjustment. The estimates use opposite contrast directions and describe different statistical quantities. Clear labeling of method and contrast order prevents apparent disagreements from being mistaken for a contradiction.

The pilot scale makes precision and planning especially relevant. The observed effect can be used in a planning illustration, but estimates from a small study are uncertain and may not be stable. Planning for a smaller effect requires a larger sample size to attain the same power target, all else equal. The illustrative calculations do not reveal the original rationale for the trial’s enrollment, which is not reported in the registry record.

Finally, the record shows the limits of interpreting a collection of outcome tests without a reported multiplicity strategy, analysis-population definition, or missing-data plan. These omissions matter because they affect how confidently readers can distinguish confirmatory evidence from exploratory patterns. The available results can be described precisely, while important questions about design and analysis remain unanswered by the registry record.

19. 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 gives limited detail on the study population. It identifies older adults and sarcopenia, but detailed eligibility criteria, participant characteristics, and age limits are not reported. This prevents assessment of how well the enrolled participants represent any particular clinical population.

The record does not explain who was masked, how masking was maintained, or whether masking could have been affected by the behavioral interventions. It describes the resistance-training schedule and the comparator visits, but does not report attendance, adherence, intervention delivery, or deviations from the planned activities. These details would help interpret how the assigned interventions were implemented.

The primary endpoint is described as change in muscle mass measured by D3Cr, but the registry does not provide technical details of the method, measurement reliability, or feasibility criteria. It does not report a functional-outcome result in the posted primary and secondary summaries. The listed correlation between changes in muscle mass is also not numerically reported.

The sponsor identifies ANCOVA as the primary reported method, but covariates and model specifications are not reported. Missing-data handling, analysis populations, the original sample-size justification, and any interim-analysis plan are not reported in the registry record. The record also does not describe a multiplicity strategy for the secondary outcomes. These gaps constrain the ability to reproduce the sponsor analysis, assess robustness, or determine how the secondary findings were intended to be interpreted.

The study is a pilot with an enrollment of 21. Its estimates and intervals should therefore be read with the uncertainty expected from a small study. The absence of detailed safety-collection information and the zero recorded event counts also limit what can be concluded about safety.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Time Course Adaptations Using Deuterated Creatine (D3Cr) Method — NCT03573583.
• Registry record last updated 2024-07-03; status last verified 2024-06.
• Results first posted 2024-07-03.
• 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.

23. Record Summary

The registry record describes a completed randomized, single-masked, parallel pilot study sponsored by the University of Florida. It lists sarcopenia and an enrollment of 21. The study compares full-body resistance training with stretching and health education classes in older adults.

The primary outcome is change in muscle mass measured by D3Cr from baseline to week 16. The posted mean changes are 3.47 for Resistance Training and 1.19 for Successful Aging. The sponsor reports an ANCOVA mean difference in final values of 2.29, with a 95% confidence interval from 0.22 to 4.36 and p = 0.03. An unadjusted re-calculation of mean changes gives -2.28 for Successful Aging minus Resistance Training, with an interval from -3.88 to -0.680 and p = 0.005.

Numerical secondary results are posted for Appendicular Lean Mass and Lean Body Mass; the correlation outcome is listed without a numerical result. The adverse-event record reports zero serious and other adverse events in the stated groups. The original sample-size justification, detailed analysis plan, missing-data methods, and multiplicity strategy are not reported in the registry record.