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 Impact of Respiratory Training in Lymphoma Survivors (NCT05938127), a na na study. The primary outcome is Total Participants Recruited.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05938127 |
| Phase | NA |
| Condition | Hodgkin Lymphoma, Non Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Colorado, Denver |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns survivors of Hodgkin lymphoma and non-Hodgkin lymphoma. The registry record does not report further eligibility details. It describes a participant who withdrew after the first visit and before randomization; no baseline measures were analyzed.
Intervention
The study names inspiratory muscle strength training and personalized exercise prescription. The listed device interventions are inspiratory muscle strength training and sham inspiratory muscle strength training. The record does not report that the withdrawn participant received either intervention.
Comparator
A sham inspiratory muscle strength training device is listed, but no randomized assignment or like-for-like comparison is reported. The registry record identifies the study as single-group, with allocation not reported.
Primary question
The stated primary endpoint is the total number of participants recruited over 12 weeks. It is a recruitment count, not a measure of metabolism, cardiovascular function, fitness, or the effect of training. No treatment-effect question can be answered from the reported primary endpoint.
The study title frames a broader question about the impact of inspiratory muscle strength training and personalized exercise prescription on metabolism, cardiovascular function, and cardiorespiratory fitness in lymphoma survivors. Listed secondary outcomes include estimated VO2max, physical function assessed primarily by the 6MWT, metabolomics from blood samples, quality of life assessed with FACT-G, and fatigue assessed with FACIT-Fatigue. These outcomes indicate areas the study intended to assess, but the registry record reports no analyses for them. The record therefore documents a research aim and planned outcome domains, not evidence about whether the interventions change those outcomes.
3. Trial Design
The registry identifies this as a single-group study, with allocation listed as not reported and masking listed as none. The two device interventions named are inspiratory muscle strength training and sham inspiratory muscle strength training. However, the record does not describe a randomized comparison, and its arm description concerns a pre-randomization group: participants who withdrew before group randomization. The record states that the participant withdrew after the first visit and before randomization. It also states that no baseline measures were analyzed.
The enrollment entry is 1, and the study status is terminated. The listed study dates are September 16, 2024, for study start and December 9, 2024, for primary completion. The primary endpoint is the number of participants recruited over 12 weeks. The registry lists 11 outcome measures and zero analyses. The record does not report a phase beyond NA, a detailed allocation procedure, or an assigned treatment for the participant described as withdrawing.
This design information limits what can be learned from the record. A single-group designation does not establish a treatment comparison, and the named sham device does not by itself mean that a control group was recruited or analyzed. The pre-randomization withdrawal means the record does not describe an observed randomized treatment experience. The study’s termination and absence of outcome analyses further mean that no intervention effect can be estimated from the posted results. The registry record does not report why the study was terminated, whether recruitment was expected to continue, or whether any participants completed an intervention.
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: Patient withdrew prior to randomization. No baseline measures were analyzed.
Overall Study
| Stage | Pre-Randomization |
|---|---|
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Analysis population for the primary outcome, as defined in the registry: Patient withdrew after visit one and prior to randomization. No baseline measures were analyzed.
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: Only one participant enrolled and subsequently withdrew before randomization. No baseline measures were analyzed.
| Characteristic | Unit | Pre-Randomization |
|---|---|---|
| Participants analysed | 0 | |
| Age, Customized: Age | Participants | — |
| Sex/Gender, Customized: Gender | Participants | — |
| Race/Ethnicity, Customized: Race/Ethnicity | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Total Participants Recruited, measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the total number of participants recruited, measured as a count over 12 weeks. Recruitment counts describe enrollment or study accrual; they do not directly measure a participant’s health, physical function, or response to an intervention. They can be relevant to whether a study enrolled participants, but interpreting recruitment also depends on the study’s intended recruitment target and the period over which recruitment was planned. Those details are not reported in the registry record.
The endpoint is distinct from a treatment-effect endpoint. A treatment-effect endpoint would compare an outcome between treatment conditions or across time, using a defined measurement such as fitness or cardiovascular function. The primary endpoint does not quantify those outcomes. Although secondary measures are listed, the registry record reports zero analyses and no baseline measures analyzed. It therefore does not provide an analyzed result for the primary endpoint or evidence about any secondary outcome. The enrollment entry is a registry study characteristic, but it is not a substitute for a separately reported, analyzed endpoint result.
In general, a recruitment count is most informative when read alongside the protocol’s recruitment goal, recruitment period, and rules for defining an enrolled participant. Those details are not reported in the registry record. The count also cannot establish why a participant withdrew or whether a study procedure was acceptable to other potential participants.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a terminated single-group study with enrollment of 1. It identifies a participant who withdrew after the first visit and before randomization, and states that no baseline measures were analyzed. The registry lists the primary endpoint as total participants recruited over 12 weeks, but reports zero analyses. Accordingly, the enrollment entry should not be mistaken for an analyzed estimate of a treatment effect or for evidence about the planned health outcomes.
The interventions named in the record are inspiratory muscle strength training and sham inspiratory muscle strength training. Because the study is listed as single-group, allocation is not reported, and the participant withdrew before randomization, the record does not support a comparison between those interventions. In particular, there is no reported basis for attributing a change in fitness, metabolism, cardiovascular function, physical function, quality of life, or fatigue to either device or to personalized exercise prescription.
The record lists 11 outcome measures, including estimated VO2max, the 6MWT, blood-sample metabolomics, FACT-G, and FACIT-Fatigue. These are outcome domains, not results. No outcome analyses, baseline measurements, effect estimates, confidence intervals, or p-values are reported in the registry record. Without analyzed observations, the size and precision of any intervention effect cannot be assessed. A confidence interval, in general, describes the uncertainty around an estimate; no such interval is reported for an intervention effect.
The adverse-event listing reports zero participants at risk, zero participants affected by serious adverse events, zero participants affected by other adverse events, and zero deaths in the pre-randomization group. Because the listed number at risk is zero, these entries do not provide an informative estimate of adverse-event frequency among treated participants. They should not be read as evidence that the interventions are free of adverse events.
The record’s status is terminated, but it does not report the reason. It also does not report whether the termination followed recruitment difficulties, operational considerations, a safety concern, or another cause. Such explanations cannot be inferred from the status alone. Overall, the posted information describes study registration and withdrawal before randomization, rather than analyzed comparative clinical findings.
9. Statistical Methods Explained
Statistical methods are useful only when they match the design, endpoint, and available observations. In this record, the primary endpoint is a participant count, the study is listed as single-group, and no outcome analyses are reported. The methods described for a hypothetical two-arm sample-size illustration should therefore be understood as planning assumptions, not as an analysis of trial outcomes.
What does a count endpoint measure?
A count records how many events of a defined kind occurred; in this study the event is recruitment of a participant. Counts differ from continuous outcomes, such as a measured fitness score, because they take whole-number values and describe event frequency rather than the magnitude of a measurement. Interpretation depends on a clear event definition and an observation period. The registry names the recruitment count and gives a 12-week timeframe, but does not report a recruitment target or further rules for counting participants.
A count alone does not establish a rate. A rate requires a meaningful exposure period or population at risk, and that denominator must be defined. Nor does a recruitment count reveal whether participants completed the intervention or provided follow-up measurements. Those are distinct study processes and outcomes.
What can a treatment comparison establish?
In general, a comparative treatment analysis requires outcome data for the conditions being compared and a design that supports the comparison. Randomization can help create comparable groups by assigning participants to conditions, while masking can reduce some forms of bias in assessment or reporting. The registry lists no masking and allocation as NA, and describes a pre-randomization withdrawal. The record therefore does not report an analyzed randomized contrast. Merely listing an active device and a sham device does not establish that participants were assigned to both or that their outcomes were compared.
For a treatment comparison, an effect estimate describes the observed contrast in outcomes, and a confidence interval conveys the estimate’s uncertainty. A p-value addresses compatibility of the data with a specified statistical null model; it does not measure the size or clinical importance of an effect. No treatment-effect estimate, confidence interval, or p-value is reported in the registry record. Since there are no reported analyses, these quantities cannot be interpreted for this study.
What do the planning assumptions mean?
The stated sample-size illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of an observed effect. These are planning assumptions, not a record of what happened in the study. The illustration is not the trial’s own design justification, and the registry record does not report a sample-size justification. No observed analyzed treatment effect is reported from which the illustration’s effect scale could be interpreted.
In general, a planning sample size estimates how many participants would be needed under specified assumptions to achieve a chosen chance of detecting an effect at a chosen significance threshold. It is not “observed power,” and it cannot compensate for absent outcome data. When an assumed effect is smaller, more participants are generally needed to detect it under otherwise comparable assumptions; that general relationship does not establish the appropriate sample size for this study. The illustration’s assumptions do not show that the trial enrolled enough participants, nor do they describe an analysis that was conducted.
The normal approximation is a mathematical approach that can simplify planning calculations. Its appropriateness depends on the outcome and assumptions about the sampling distribution. For count outcomes, the distribution and variation may not behave like a normal distribution, particularly when observations are sparse or variable. Over-dispersion is a general situation in which count variation exceeds what a simple count model expects; accounting for it can affect uncertainty and planning. The registry record does not report a count model, an over-dispersion assessment, or a detailed statistical analysis plan. These general considerations should not be mistaken for methods documented as used in this study.
What can be inferred from no analyses?
With zero analyses listed, there is no reported inferential result to evaluate. There is no basis to decide whether an apparent difference is statistically distinguishable from chance, how precise an estimate is, or whether a result is robust to alternative assumptions. A missing analysis is not a null finding: it does not show that an intervention had no effect. It means the registry record does not report an analysis from which an effect could be estimated.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Pre-Randomization | 1 | 1 | 100.0% | 2.5% to 100.0% | 20.7% to 100.0% | 15.8% to 98.7% |
R code and output
arm <- c("Pre-Randomization")
n <- c(1)
events <- c(1)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Pre-Randomization 1 1 100.0 2.5 100.0 20.7 100.0 15.8 98.711. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and identifies several secondary domains: estimated VO2max for cardiorespiratory fitness, the 6MWT for physical function, metabolomics from blood samples, FACT-G for quality of life, and FACIT-Fatigue for fatigue. The registry record does not report which outcomes were designated primary or secondary beyond the stated recruitment endpoint and these listed secondary outcomes, nor does it report a plan for controlling multiplicity across analyses.
Multiplicity arises when several hypotheses or outcomes are assessed. In general, testing many outcomes can increase the chance of obtaining at least one apparently unusual result by chance. Statistical plans may address this through a prespecified hierarchy or adjustment, but no such approach is reported in the registry record. Since zero analyses are listed, there are no reported outcome tests for which multiplicity adjustment can be evaluated.
Missing-data procedures and analysis populations are also not reported in the registry record. The record says the participant withdrew after visit one and before randomization, and that no baseline measures were analyzed. It does not describe any imputation method, rules for handling incomplete follow-up, or a population definition for an efficacy analysis. With no reported outcome analyses, there is no information about how missing observations would affect estimates.
The record does not report interim analyses, a monitoring plan, or a statistical analysis plan. Their absence from the registry record should not be filled in by assumption. The pre-randomization withdrawal and the absence of baseline analysis are directly relevant to interpretation: the record does not contain the analyzed follow-up data needed to assess the listed clinical outcomes.
12. What the Result Does, and Does Not, Mean
The posted results support a narrow description: the registry reports enrollment of 1, identifies a participant who withdrew after the first visit and before randomization, and states that no baseline measures were analyzed. The study is marked terminated, and the registry lists zero analyses. These registry entries describe the status of the study record and its reported data, not the effects of inspiratory muscle strength training, sham training, or personalized exercise prescription.
The record does not show that either device improved or worsened cardiorespiratory fitness, cardiovascular function, metabolism, physical function, quality of life, or fatigue. It also does not show that either device had no effect. Without analyzed outcome data and a valid comparison, neither conclusion follows. The named outcome measures indicate what the study intended to assess, but naming a measure is not the same as reporting a result.
Likewise, the adverse-event entries do not establish safety. The pre-randomization group has zero participants listed at risk, with zero affected by serious or other adverse events and zero deaths. Those entries do not describe adverse-event experience among participants who received an intervention. They cannot support a conclusion about the presence or absence of harms during treatment.
The recruitment count may be relevant to study feasibility, but the registry record does not report a recruitment goal or a separately analyzed endpoint result. It does not explain why the participant withdrew or why the study was terminated. Conclusions about acceptability, recruitment barriers, or causes of termination would therefore go beyond the record. The results should be interpreted as incomplete for evaluating intervention effects, rather than as evidence for or against a clinical benefit.
13. Why This Trial Matters Statistically
This record illustrates why a trial’s design and analysis status matter as much as its intervention names. A registry may list active and sham interventions and a range of clinically relevant outcomes, yet still provide no comparative result. Here, the study is described as single-group, the participant withdrew before randomization, and no baseline measures were analyzed. Those features mean the record does not contain an analyzed treatment contrast.
It also illustrates the difference between a study characteristic and an endpoint result. The enrollment entry is 1, while the primary endpoint is defined as total participants recruited over 12 weeks. The record lists zero analyses, so the enrollment entry should not be treated as an analyzed effect estimate. Recruitment counts answer a different question from outcomes such as estimated VO2max, the 6MWT, or quality-of-life scores.
Finally, the record distinguishes planning assumptions from completed analyses. The stated sample-size illustration describes assumptions for a hypothetical two-arm planning calculation; it is not evidence that the study conducted such a comparison or achieved a particular power. Reading those assumptions alongside the absence of analyses helps prevent planning quantities from being mistaken for clinical findings. For researchers, this is a reminder to distinguish registered intentions, study conduct, and analyzed evidence when interpreting a trial record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves important design details unreported. It lists the phase and allocation as NA and does not provide a detailed eligibility description, recruitment target, or statistical analysis plan. Although the two device interventions are named, the record does not report that the participant was assigned to either intervention. The single-group designation and pre-randomization withdrawal do not support a like-for-like comparison.
The primary endpoint concerns recruitment, not a clinical outcome. The record does not report an analyzed primary endpoint result, despite listing enrollment of 1. It lists 11 outcome measures but zero analyses. No baseline measures were analyzed, and no clinical outcome estimates, uncertainty intervals, or hypothesis tests are reported. This prevents assessment of both the magnitude and precision of any intervention effect.
The study is marked terminated, but the reason is not reported in the registry record. The record also does not explain the withdrawal, report whether any intervention was initiated, or describe follow-up beyond the withdrawal account. The adverse-event group lists zero participants at risk, limiting what can be inferred about harms. These limitations are specific to the information recorded for this study; they do not establish why the study stopped or what its unreported data might have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Impact of Respiratory Training in Lymphoma Survivors — NCT05938127.
- Registry record last updated 2026-02-27; status last verified 2026-02.
- Results first posted 2026-02-27.
- 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.
18. Record Summary
The registry record describes the study “Impact of Respiratory Training in Lymphoma Survivors,” sponsored by University of Colorado, Denver. It concerns Hodgkin lymphoma and non-Hodgkin lymphoma survivors and names inspiratory muscle strength training and sham inspiratory muscle strength training devices. The official title also refers to personalized exercise prescription and outcomes involving metabolism, cardiovascular function, and cardiorespiratory fitness.
The study is listed as single-group, with allocation NA and masking none. Enrollment is 1; the record describes a participant who withdrew after visit one and before randomization, with no baseline measures analyzed. The primary endpoint is total participants recruited over 12 weeks. The registry lists 11 outcome measures and zero analyses, and the status is terminated. No intervention-effect analysis or reason for termination is reported in the registry record.