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 Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health (NCT03771417), a randomized na study. The primary outcome is Skeletal Muscle Strength.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03771417 |
| Phase | NA |
| Condition | Aging, Sarcopenia, Disability Physical |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Louisiana State University and A&M College |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns older adults. Its official title describes skeletal muscle and cardiometabolic health in older adults, and the record lists aging, sarcopenia, physical disability, cardiovascular diseases, insulin resistance, and diabetes mellitus among its conditions. The registry record does not report detailed eligibility criteria, such as age thresholds or how these conditions related to enrollment.
Intervention
One group was assigned to supervised resistance exercise two days per week. A second group combined supervised resistance exercise two days per week with regular, unsupervised low-intensity physical activity breaks in sedentary time five days per week. The description specifies six ten-minute breaks per day at two metabolic equivalents, or approximately 30-40% of peak oxygen consumption.
Comparator
The posted results include a third group: supervised resistance exercise combined with supervised, calorically matched moderate-intensity physical activity. That activity was planned for three days per week, with 50-minute sessions at four metabolic equivalents and approximately 500 kcal per week above resting metabolism. The registry record does not identify a formal primary comparison in the results.
Primary question
The primary endpoint asks how leg press one-repetition maximum strength changed from baseline to week 16 in each group. The registry's study questions also concern skeletal muscle and cardiometabolic health, but the posted primary result is skeletal muscle strength. It gives a mean change for each group, not an estimated difference between groups.
3. Trial Design
This is a randomized, parallel-group pilot study with no masking reported. The registry record lists an enrollment of 24 and a completed status. The study start date is 2019-01-16, and the primary completion date is 2023-02-09. The record identifies Louisiana State University and A&M College as the sponsor. The phase is listed as not applicable.
Three exercise groups appear in the posted primary results. The resistance-exercise group was assigned supervised resistance exercise two days per week. The RE plus low-intensity physical activity group combined the same resistance-exercise schedule with unsupervised activity breaks on five days per week. The RE plus moderate-intensity exercise group combined resistance exercise with supervised, calorically matched moderate-intensity physical activity three days per week. These are the registry descriptions; the record does not provide information about adherence or the amount of exercise participants completed.
For the primary outcome, the registry reports a result for each group: resistance exercise, n = 6; RE plus moderate-intensity exercise, n = 8; and RE plus low-intensity physical activity, n = 7. The record's enrollment figure and these outcome-specific group counts describe different items; it does not explain the relationship between them. The record does not report a participant flow account or explain why the outcome counts differ across groups.
The study is labeled a pilot study, but its protocol, objectives for pilot feasibility, and rationale for its planned enrollment are not reported in the registry record. Random allocation indicates that participants were assigned by chance, but the record does not describe the randomization procedure or allocation concealment. No masking is listed. The record does not specify whether participants, study staff, or outcome assessors were masked, and no masking should not be read as proof about every individual involved in measurement.
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: 24 participants were enrolled in the present study, 23 participants were randomized. 1 participant did not complete baseline testing.
Overall Study
| Stage | Resistance Exercise | RE Plus Low Intensity Physical Activity | RE Plus Moderate Intensity Exercise |
|---|---|---|---|
| STARTED | 7 | 8 | 8 |
| COMPLETED | 6 | 7 | 8 |
| NOT COMPLETED | 1 | 1 | 0 |
Reasons for not completing this period:
| Reason | Resistance Exercise | RE Plus Low Intensity Physical Activity | RE Plus Moderate Intensity Exercise |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 |
| Covid-19 Shutdown | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Change is Leg Press 1-RM
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.
Population: One participant in the resistance training group withdrew from the study due to time conflict, and one participant in the RE plus Low Intensity Physical Activity was lost to follow-up due to shutdown of campus during the beginning of the covid 19 pandemic.
| Characteristic | Unit | Resistance Exercise | RE Plus Low Intensity Physical Activity | RE Plus Moderate IntensityExercise | Total |
|---|---|---|---|---|---|
| Participants analysed | 7 | 8 | 8 | 23 | |
| Age, Continuous | years | 70.3 (SD 2.9) | 70.4 (SD 3.9) | 69.5 (SD 5.0) | 70.0 (SD 3.9) |
| Sex: Female, Male: Female | Participants | 5 | 6 | 5 | 16 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 3 | 7 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 1 | 4 |
| Race (NIH/OMB): White | Participants | 5 | 7 | 7 | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 7 | 8 | 8 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Skeletal Muscle Strength, measured over Measured at week 0 (baseline) and week 16.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Change in Lbs |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in leg press one-repetition maximum strength, reported in pounds. It is measured at baseline, identified as week 0, and again at week 16. The registry describes the broader primary outcome as skeletal muscle strength and says measurements were performed using isokinetic dynamometry and one-repetition maximum testing. The population-specific endpoint reported in the results is change in leg press one-repetition maximum.
A one-repetition maximum is the greatest load a person can lift once under the test conditions. As a measure of strength, it gives a direct, interpretable performance result rather than an indirect laboratory marker. Reporting change from baseline focuses on how the measured value differs over the intervention period, while reporting results by group allows readers to inspect each group's observed mean change.
The posted values are mean changes with standard errors. The resistance-exercise group had a mean change of 93.9 lbs (standard error 17.9; n = 6). The RE plus moderate-intensity exercise group had a mean change of 50.0 lbs (standard error 15.2; n = 8). The RE plus low-intensity physical activity group had a mean change of 78.6 lbs (standard error 15.2; n = 7). These are within-group summaries. The registry record does not report an estimated between-group difference or a confidence interval for such a difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results describe mean change in leg press one-repetition maximum strength from baseline to week 16, in pounds. All three group estimates are positive: 93.9 lbs for resistance exercise, 50.0 lbs for RE plus moderate-intensity exercise, and 78.6 lbs for RE plus low-intensity physical activity. The record gives standard errors of 17.9, 15.2, and 15.2, respectively, and outcome counts of 6, 8, and 7. These summaries describe the observed results in each group; they do not establish which group had a greater average change.
A group mean is not an individual participant's result. It condenses the outcomes within a group into one average, so it does not show the full spread of individual changes or how many participants improved, stayed the same, or changed in another direction. The standard error describes uncertainty around an estimated group mean, not the range of individual responses. The record does not provide standard deviations or individual-level results for this endpoint.
Most importantly for a randomized comparison, the registry record does not report a direct contrast between any two groups for the primary endpoint. It also does not report a confidence interval or p-value for a between-group contrast. Comparing the three mean changes informally is not a substitute for a randomized treatment-effect estimate: a valid comparison needs to account for the uncertainty in both groups and follow the trial's analysis plan. That plan is not reported in the registry record. The record specifically lacks values needed to estimate a two-arm comparison for this continuous endpoint.
The values therefore support a descriptive reading of what was posted, not a conclusion about comparative effectiveness. They do not establish that one exercise program caused a larger change than another, nor do they establish that the observed group means would be reproduced in a wider population. The study is identified as a pilot, and the outcome counts are modest; the record does not provide a sample-size justification or precision target. The reported standard errors indicate that the group means themselves have uncertainty, while the absence of a reported contrast leaves the uncertainty about differences between groups unquantified.
One secondary outcome is listed as mitochondrial function, and the record indicates three outcome measures overall. The posted primary result alone does not describe that secondary outcome or other unreported outcomes. The registry record also does not report adherence, details of missing outcome data, or an analysis population definition. Those omissions limit interpretation of how completely the results reflect the randomized groups and how they relate to the full set of planned study questions.
9. Statistical Methods Explained
The primary endpoint is continuous: it is a numerical change in leg press one-repetition maximum strength, measured in pounds. The registry reports each group's mean change and standard error. A mean is a measure of the group's average result. A standard error expresses the statistical uncertainty in that estimated average. It is not the same as a standard deviation, which describes how spread out individual observations are within a group.
General statistical explanation: Confidence intervals are a way to express uncertainty around an estimate. A confidence interval for a mean difference would show a range of values compatible with the data and the statistical model. The registry record does not report a confidence interval for a between-group difference in the primary outcome. The posted standard errors for separate group means are not a replacement for such an interval, because they do not themselves state the estimated contrast and its uncertainty.
General statistical explanation: In a randomized parallel-group trial, the main comparative question is usually addressed by estimating a difference between assigned groups, rather than treating each group's change as a separate test. The comparison should be tied to a prespecified analysis, including how baseline measurements and missing observations are handled. The registry record does not report the statistical analysis plan, an adjusted or unadjusted contrast, or a test of a between-group difference. No comparison should be inferred simply from the ordering of the displayed mean changes.
The endpoint is defined as change from baseline, with measurements at week 0 and week 16. Change scores summarize the movement between those measurements. The record does not say whether the comparison was to be analyzed using change scores, a model adjusting for baseline, or another method. These approaches can differ in their assumptions and precision; without the analysis plan or a posted comparison, the choice cannot be established from the registry record.
General statistical explanation: A standard error depends on the variability in the data and the amount of information available. In a small group, the estimated mean can be sensitive to the results of individual participants. Standard errors can help readers understand uncertainty in group averages, but they do not reveal the complete distribution of outcomes. The registry does not post individual observations or standard deviations for the primary endpoint, so those features cannot be assessed from these summaries.
The posted group counts for the primary endpoint are 6, 8, and 7. The registry separately lists enrollment as 24. It does not explain the relationship between overall enrollment and the outcome counts, nor does it report reasons for missing endpoint results. The analysis population—such as whether results include all randomized participants or only participants with an available measurement—is not reported in the registry record. That information matters because excluding participants with missing results can affect how representative the reported means are of the randomized groups.
The study has three intervention groups, so a complete comparative analysis could involve multiple group contrasts. The registry record does not state which contrast was primary, whether additional comparisons were planned, or how multiplicity was addressed. Multiplicity refers generally to the increased chance of a false-positive finding when several hypotheses are tested. This is a concern to consider when reading a set of multiple comparisons, but no inferential comparisons are posted for this outcome. The record indicates three outcome measures and lists mitochondrial function as a secondary outcome; it does not give a full analysis plan for these outcomes.
General statistical explanation: Over-dispersion is a concern for some count-data models when the observed variability is greater than the model assumes. It is not a feature that can be assessed from these continuous mean-change summaries, and the registry does not report a count-data analysis for the primary endpoint. Likewise, time-to-event methods are not relevant to the posted strength outcome as described; the primary endpoint is a continuous measure at two assessment times.
The record does not provide a sample-size justification, anticipated treatment effect, or statistical power target for the trial. The sample-size illustration described alongside the posted results is a planning exercise based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations ask what sample size would be needed under stated assumptions to detect a chosen fraction of an observed effect. They are not the trial's own design justification and are not observed power. No numerical illustration results are stated in the registry record, so none can be interpreted.
These distinctions separate descriptive summaries from inferential results. The means and standard errors characterize posted group-level results. A randomized comparison would require an estimated contrast and its uncertainty, accompanied by a clear account of the analysis population and approach to missing values. Those elements are not reported in the registry record, so the posted summaries cannot answer the comparative question on their own.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Resistance Exercise | 6 | 93.900 | 43.846 | 47.887 to 139.913 |
| RE Plus Moderate Intensity Exercise | 8 | 50.000 | 42.992 | 14.058 to 85.942 |
| RE Plus Low Intensity Physical Activity | 7 | 78.600 | 40.215 | 41.407 to 115.793 |
R code and output
arm <- c("Resistance Exercise", "RE Plus Moderate Intensity Exercise", "RE Plus Low Intensity Physical Activity")
n <- c(6, 8, 7)
m <- c(93.9, 50, 78.6)
sp <- c(17.9, 15.2, 15.2)
sd <- sp * sqrt(n) # standard errors converted to SDs
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Resistance Exercise 6 93.900 43.846 47.887 139.913
CARM RE Plus Moderate Intensity Exercise 8 50.000 42.992 14.058 85.942
CARM RE Plus Low Intensity Physical Activity 7 78.600 40.215 41.407 115.79311. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and identifies mitochondrial function as a secondary outcome. It does not report a complete statistical analysis plan, a hierarchy of outcomes, which comparisons were prespecified, or whether any multiplicity adjustment was planned. Multiplicity refers generally to the challenge of interpreting several statistical tests together. Because no two-arm result is posted for the primary continuous endpoint, the record does not permit an assessment of how a family of comparative tests was handled.
For the primary endpoint, the record reports outcome counts of 6 for resistance exercise, 8 for RE plus moderate-intensity exercise, and 7 for RE plus low-intensity physical activity. It also reports total enrollment of 24. It does not explain the relationship between these figures, identify participants with missing week 16 measurements, or state how missing endpoint data were treated. The reason for any difference between enrollment and outcome counts is not reported in the registry record.
The analysis population is also not reported in the registry record. It is therefore unclear whether these summaries represent all randomized participants, participants who completed the intervention, or another group defined for analysis. The registry does not describe imputation, sensitivity analyses, exclusions, or how participants who did not complete follow-up were handled. These details matter because the method used to handle unavailable outcomes can influence estimates and their uncertainty.
The record reports zero posted analyses. That does not establish that no analyses were conducted; it means the registry record does not provide analysis details or comparative estimates to evaluate. Consequently, interpretation should remain limited to the descriptive group means and standard errors that are posted.
12. 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 |
|---|---|---|---|
| Resistance Exercise | 0 | 7 | 0.0% |
| RE Plus Moderate Intensity Exercise | 0 | 8 | 0.0% |
| RE Plus Low Intensity Physical Activity | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Resistance Exercise | 0 of 7 |
| RE Plus Moderate Intensity Exercise | 0 of 8 |
| RE Plus Low Intensity Physical Activity | 0 of 8 |
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 |
|---|---|
| Resistance Exercise | 0 of 7 |
| RE Plus Moderate Intensity Exercise | 0 of 8 |
| RE Plus Low Intensity Physical Activity | 2 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Resistance Exercise | RE Plus Moderate Intensity Exercise | RE Plus Low Intensity Physical Activity |
|---|---|---|---|---|
| Fall | Investigations | 0 of 7 | 0 of 8 | 1 of 8 |
| Vasovagal | Cardiac disorders | 0 of 7 | 0 of 8 | 1 of 8 |
The adverse-event figures are reported by group. For serious adverse events, the registry lists 7 participants at risk in the resistance-exercise group, 8 in the RE plus moderate-intensity exercise group, and 8 in the RE plus low-intensity physical activity group. The number affected by a serious adverse event is 0 in each group. The record lists 0 deaths in each group.
For other adverse events, the record lists 0 affected among 7 at risk in the resistance-exercise group, 0 among 8 at risk in the RE plus moderate-intensity exercise group, and 2 among 8 at risk in the RE plus low-intensity physical activity group. These are the posted counts; they should not be treated as rates or as evidence about whether an event was caused by an intervention. No serious adverse-event terms are listed.
General interpretation: an at-risk count identifies the group size used in the adverse-event summary, while the affected count states how many participants were recorded with the event category. Small group counts provide limited information about uncommon harms. The registry record does not describe event definitions, severity grading beyond the serious/other categories, timing, or the method for assessing attribution. These counts are therefore a compact record of reported events, not a complete safety profile.
13. What the Result Does, and Does Not, Mean
The posted results answer a descriptive question: what mean change in leg press one-repetition maximum strength was recorded in each group from baseline to week 16? The mean changes are 93.9 lbs with resistance exercise, 50.0 lbs with RE plus moderate-intensity exercise, and 78.6 lbs with RE plus low-intensity physical activity. The standard errors and group counts provide context for those summaries.
They do not answer the central comparative question of whether one assigned program produced a larger change than another. The registry record does not report a between-group estimate, confidence interval, or p-value for the primary endpoint. The group means alone cannot establish a treatment effect or determine whether apparent differences between groups are compatible with chance variation. Any statement that ranks the programs as statistically different would go beyond what is reported.
Nor do these results describe the experience of every participant. A mean can conceal varied individual changes, and the record does not provide individual-level values or a distribution of responses. The group counts are limited, and the registry does not report an enrollment rationale or precision target. The results therefore should not be taken as a precise estimate of what would occur in a broader population.
The exercise descriptions clarify what each group was assigned, but adherence and actual activity completed are not reported in the registry record. Thus the posted outcome summaries do not show whether participants completed the prescribed schedules. Similarly, the record does not provide enough information about missing data or analysis populations to determine how fully the group summaries represent all randomized participants.
The record also lists mitochondrial function as a secondary outcome, but the primary strength result does not establish findings for that or other outcomes. The appropriate interpretation is narrow: these are the posted group-level mean changes and standard errors for the primary strength measure, without a reported inferential comparison. They neither prove nor disprove a comparative benefit, and they do not support medical advice.
14. Why This Trial Matters Statistically
This pilot study is statistically informative because it illustrates the difference between reporting group summaries and reporting a randomized comparison. The registry gives mean changes in strength for three exercise groups, along with standard errors and outcome counts. Those numbers allow a descriptive account of the observed group averages, but a reader seeking evidence about differences between programs needs a direct estimate of a contrast and its uncertainty.
The record does not post that contrast for the primary endpoint. This matters because a visual or informal comparison of group means does not account for the uncertainty in both groups, and it does not substitute for an analysis that reflects the randomized design. Without the analysis plan, it is also not possible to know which comparison was intended to answer the primary question or how multiple outcomes and contrasts were handled.
The study is identified as a pilot, and the primary endpoint counts are 6, 8, and 7. Pilot data can describe observed outcomes and may help frame questions for further study, but the registry does not report a sample-size justification or a precision target. Any planning exercise based on an observed effect is distinct from the original design rationale and should not be confused with observed power.
Finally, the record highlights why transparent reporting matters. Information about participant flow, missing outcomes, analysis populations, adherence, and uncertainty around between-group effects would help readers understand how the posted summaries were produced and what they can support. In their absence, careful statistical interpretation means keeping the conclusion descriptive and recognizing the unanswered comparative questions.
15. 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.
Several trial-specific limitations arise from what is and is not reported in the registry record. The study is labeled a pilot, but the record does not give its sample-size justification, target precision, or intended role in informing later research. The primary outcome counts are 6, 8, and 7, and the record does not explain how these counts relate to the enrollment of 24.
The primary results are group-specific means and standard errors, not an estimated randomized contrast. No confidence interval or p-value for a between-group comparison is reported. The statistical analysis plan, including any baseline adjustment or prespecified comparison, is not reported in the registry record. As a result, the posted values cannot establish a comparative effect.
Missing-data handling and analysis populations are not described. The registry does not report participant flow, reasons for unavailable measurements, imputation, or sensitivity analyses. Adherence and actual completion of the exercise schedules are also not reported. These gaps limit interpretation of how the assigned programs were delivered and how representative the outcome summaries are of all randomized participants.
The study has three groups and lists multiple outcome measures, including mitochondrial function as a secondary outcome. The record does not report a hierarchy of hypotheses or a multiplicity strategy. Further, the absence of masking may be relevant to the conduct of an exercise study, but the record does not specify which people were unmasked or how outcome assessment was conducted. These reporting limits should be distinguished from evidence that a particular bias occurred.
The safety summaries are counts, and details about event definitions, timing, severity, and attribution are not reported. Taken together, these limitations support a cautious, descriptive reading rather than a definitive comparative conclusion.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health — NCT03771417.
- Registry record last updated 2025-03-19; status last verified 2025-03.
- Results first posted 2025-03-19.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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.
19. Record Summary
The registry record describes a completed randomized, parallel-group pilot study with no masking reported, sponsored by Louisiana State University and A&M College. It lists enrollment of 24 and compares resistance exercise alone with resistance exercise combined with low-intensity activity breaks or supervised moderate-intensity activity. The primary endpoint is change in leg press one-repetition maximum strength from baseline to week 16, measured in pounds.
Posted mean changes are 93.9 lbs (standard error 17.9; n = 6) for resistance exercise, 50.0 lbs (standard error 15.2; n = 8) for RE plus moderate-intensity exercise, and 78.6 lbs (standard error 15.2; n = 7) for RE plus low-intensity physical activity. The registry record does not report a two-arm comparison for this continuous outcome. It lists mitochondrial function as a secondary outcome and reports adverse-event counts by group, including zero serious adverse events and zero deaths in all groups.