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 Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial (NCT05568511), a randomized na study. The primary outcome is Safety (Number of Adverse Events).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05568511 |
| Phase | NA |
| Condition | Exercise Program, Standard Care Control |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 21 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Florida |
| Results posted | Yes |
2. Clinical Question
Population
Older sepsis survivors recruited at discharge from hospital to home are the population described in the registry summary. The summary identifies distance from research facilities and limited access to rehabilitation services as problems motivating remote delivery. Specific age thresholds, eligibility criteria, and details of the enrolled participants are not reported in the registry record.
Intervention
The intervention is an app-based exercise program, also described as a home-based, digitally delivered exercise training program. The registry record does not report the exercise schedule, intensity, duration, progression, adherence expectations, or how support was delivered.
Comparator
The comparator is standard care, identified in the record as the standard care control group. The nature and content of standard care are not described in the registry record, so the contrast cannot be characterized as exercise versus a specified rehabilitation regimen.
Primary question
The posted primary outcome is safety, measured as the number of adverse events recorded from baseline to 3 months. The record lists 11 events for the exercise intervention arm and 16 for the standard care control group. These are event counts, not a reported estimate of a causal treatment effect; a two-arm inferential analysis is not reported in the registry record.
The trial title and summary also frame the research around physical function and the possibility of remotely delivered rehabilitation. Two posted secondary outcomes are the 30-second Sit-to-Stand Test and the 4-Stage Balance Test. However, the registry record does not post their results or an analysis comparing the arms on those measures. As a result, the posted primary outcome should not be treated as a direct measure of physical function, and the trial description alone does not answer whether the exercise program changed physical function. The record gives a randomized, parallel design, but it does not report details sufficient to establish how assignment was implemented or how masking was maintained.
3. Trial Design
The HEAL Sepsis Trial is listed as a randomized, double-masked, parallel study sponsored by the University of Florida. Its status is completed. The registry record lists enrollment of 21 and two arms: Exercise Intervention, with 10 participants, and Standard Care Control Group, with 11 participants. The intervention is named an app-based exercise program; the control is named standard of care. The record does not describe the allocation sequence, concealment procedures, or which people were masked. The meaning and practical implementation of double masking are therefore not reported in the registry record.
The study dates recorded are a start date of 2023-03-29 and a primary completion date of 2025-07-29. The phase is listed as NA. The summary describes recruiting older sepsis survivors at discharge from hospital to home and assigning them to exercise training or standard care. More specific eligibility criteria, recruitment details, sites, and participant characteristics are not reported in the registry record.
The primary outcome is safety, expressed as the number of adverse events from baseline to 3 months. Two secondary outcomes are named: the 30-second Sit-to-Stand Test and the 4-Stage Balance Test. The record indicates four outcome measures, but only two secondary outcomes are identified in the posted information. The other outcome measures are not reported in the registry record. It also records no posted analysis entries. This means the registry entry does not offer an inferential comparison for the listed outcomes; it does not establish whether analyses were conducted outside the registry.
The arm descriptions contain no further details. Exercise content, delivery frequency, adherence monitoring, control-group care, follow-up procedures, and rules for handling changes in participation are not reported in the registry record. Those omissions limit assessment of what the randomized contrast represented in practice.
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 | Exercise Intervention | Standard Care Control Group |
|---|---|---|
| STARTED | 10 | 11 |
| COMPLETED | 9 | 11 |
| NOT COMPLETED | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: One participant in the exercise group withdrew from the study; therefore, nine participants were included in the exercise adherence analysis.
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 | Exercise Intervention | Standard Care Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 11 | 21 | |
| Age, Continuous | years old | 69.6 (SD 8.5) | 72.3 (SD 7.9) | 71 (SD 8.1) |
| Sex: Female, Male: Female | Participants | 4 | 5 | 9 |
| Sex: Female, Male: Male | Participants | 6 | 6 | 12 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 9 | 9 | 18 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Total Sequential Organ Failure Assessment (SOFA) score | scores on a scale | 3.1 (SD 0.7) | 2.7 (SD 1.1) | 2.9 (SD 0.9) |
6. Primary Endpoint
The registry lists the primary outcome as Safety (Number of Adverse Events), measured over Baseline to 3 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events recorded from baseline to 3 months. The registry record describes it as a number of events, rather than as a proportion of participants with an event or a time-to-event measure. It lists 11 events in the Exercise Intervention arm and 16 in the Standard Care Control Group. The record does not provide an accompanying measure of variability, a confidence interval, or a statistical test for this endpoint.
Counting events can be useful in a safety assessment because it records the burden of events over the study period. But an event count and a count of participants experiencing at least one event answer different questions: a participant can experience more than one event. The registry record does not explain event-level counting rules, whether recurrent events were included, or how events were attributed to the follow-up period. Nor does it provide participant-level distributions or time at risk. These details matter when interpreting event totals, particularly when the arms differ in size.
In general, safety endpoints may be reported as event counts, affected-participant counts, event rates, or time-to-event outcomes. Each uses different information and supports different interpretations. Here, the posted primary endpoint is a count, and no adjusted or unadjusted treatment-effect estimate is reported in the registry record. The endpoint is used to describe safety during follow-up; by itself, the listed pair of counts does not establish whether the arms differ beyond what could be explained by chance or by differences in exposure and event recurrence.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome values are 11 adverse events for the Exercise Intervention arm and 16 for the Standard Care Control Group. Enrollment is listed as 10 and 11 participants, respectively. These figures describe the recorded totals, but the registry record does not provide a treatment-effect estimate, confidence interval, or p-value for the primary outcome. The comparison therefore has no posted inferential result from which to assess the precision of an arm difference.
Event totals should not be read as the number of participants affected. The adverse-event information separately reports serious events affecting 1 of 10 participants in the exercise arm and 1 of 11 in standard care, and other adverse events affecting 6 of 10 and 7 of 11, respectively. These participant figures are not interchangeable with the primary outcome event totals. The registry does not describe whether participants could experience multiple events, how each event was classified, or whether an event could appear in more than one category.
The registry identifies the study as randomized, which describes the intended design for comparing assigned groups. Randomization does not, on its own, make the posted event counts a conclusive estimate of a treatment effect. Interpretation also depends on event definitions, follow-up completeness, analysis methods, and uncertainty. These details, along with the statistical comparison, are not reported in the registry record. Because the enrollment is limited, the event totals should be treated as descriptive information rather than as a precise estimate of relative safety.
Physical function is part of the trial's motivation, but the registry record does not post results for the 30-second Sit-to-Stand Test or the 4-Stage Balance Test. The primary endpoint is safety, not a physical-function measure. The record therefore does not support a conclusion about the effect of the exercise program on physical function. The listed results also do not establish that either intervention is safer or less safe; there is no reported statistical analysis that quantifies uncertainty around the comparison.
In general, a confidence interval communicates the range of effect estimates compatible with the data under an analysis model. Without one, readers cannot judge the precision of a treatment-effect estimate for this endpoint. The event totals remain useful as a description of what the registry records, but they do not resolve the comparative question. The registry record does not report a sample-size justification, interim analyses, or a statistical analysis plan, so the rationale for the enrollment and the planned inferential approach cannot be assessed from the posted information.
9. Statistical Methods Explained
The study is recorded as randomized, double-masked, and parallel. In general, random assignment is intended to make comparison groups similar on average with respect to factors that could affect outcomes. A parallel design assigns participants to one group for comparison with the other group. These are design descriptions, not evidence that allocation procedures or masking were implemented in a particular way. The allocation method, concealment, and identities of those masked are not reported in the registry record.
What does the primary event count represent?
The primary outcome is the number of adverse events during the period from baseline to 3 months. A count outcome records how many events occurred, rather than measuring the time until an event or simply whether a participant had any event. In general, count analyses may account for differences in observation time and for variation in event counts between participants. Whether such methods are appropriate depends on how the data were collected and on the distribution of event counts. The registry record does not report the event-level data, a dispersion measure, a model, or an analysis of the count endpoint.
In general, over-dispersion means that the observed variation in counts is greater than expected under a simple count model. If present, it can affect the uncertainty estimated for a comparison. The record does not provide information to assess over-dispersion or say whether it was considered. No model choice, covariate adjustment, or treatment-effect scale is reported in the registry record.
Why are the arm totals not an inferential comparison?
The posted primary values are 11 events and 16 events, with 10 and 11 participants listed in the respective arms. The registry entry identifies the endpoint as a count and indicates that values are missing or not estimable for a two-arm comparison of this count-other endpoint. It reports no analysis entries. As a result, there is no posted estimate of the difference between groups, no confidence interval, and no p-value to interpret. The values should be read as descriptive arm totals, not as a recalculated or adjusted comparison.
In general, an inferential comparison combines an effect estimate with uncertainty under a stated statistical model. A confidence interval describes uncertainty around an estimate; a p-value addresses compatibility of the data with a specified null hypothesis under the analysis assumptions. Neither can be reconstructed responsibly from the posted arm totals alone without additional information about the data structure and analysis. No such inferential result is reported in the registry record.
What do the planning assumptions mean?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It specifies that the effect to detect is a stated fraction of the observed effect. Such a calculation is a planning exercise, not observed power and not evidence that a particular effect was detected. Sample-size illustrations indicate how many participants per arm might be needed under their assumptions; they do not change the trial's observed enrollment or establish the precision of its results. For this count-other endpoint, the record flags the values as not estimable for a two-arm comparison. No usable planning sample-size values are reported in the registry record.
In general, planning calculations depend on assumptions about the outcome, effect size, variability, allocation, significance threshold, and desired power. If the assumptions do not match the trial's endpoint or analysis, the illustration may not reflect the actual design. The registry record does not report a trial-specific sample-size justification or a planned power target. It is therefore not possible to assess whether the enrollment of 21 was selected to detect a particular safety difference.
What can be inferred from the other safety summaries?
The safety record distinguishes serious events from other adverse events and provides counts of affected participants in each arm. It also lists deaths as 1 in the exercise arm and 0 in the standard care arm, and identifies Death at 10.0% and Hospitalization at 9.1% among the top serious terms. These details are descriptive. The record does not provide confidence intervals or tests for these safety categories, nor does it explain whether categories overlap or how terms were coded. No comparative risk estimate should be inferred from the summaries alone.
More generally, safety assessment can consider event severity, frequency, timing, recurrence, and the number of participants exposed. The registry information does not include enough detail to examine those dimensions fully. The record also does not state whether any interim safety reviews occurred or describe a monitoring process. Such procedures are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names the primary safety outcome and two secondary outcomes: the 30-second Sit-to-Stand Test and the 4-Stage Balance Test. It indicates four outcome measures overall, but does not identify all of them in the posted information. A multiplicity strategy for handling multiple outcomes or multiple tests is not reported in the registry record. In general, when several outcomes are examined, the chance of at least one apparently notable result can increase; planned procedures can address that issue. No such procedure can be assessed from the posted record.
The registry contains no analysis entries. It does not report whether the named secondary outcomes were analyzed, whether additional time points or subgroups were examined, or whether any adjustments were planned. The absence of posted analyses does not establish that analyses were not conducted elsewhere; it means that the registry record does not give their methods or results.
Missing-data rules and the handling of withdrawals are not reported in the registry record. There is no posted description of outcome completion, reasons for missing observations, imputation, or sensitivity analyses. Likewise, the analysis population is not specified: the record does not say whether analyses were planned by randomized assignment, by treatment received, or under another definition. These omissions matter because incomplete follow-up or different analysis populations can affect interpretation, especially when the outcome is collected over a follow-up period.
The randomized design is recorded, but the registry information does not establish how the analysis preserved the randomized comparison or handled participants with unavailable outcomes. Statistical methods, multiplicity procedures, missing-data methods, and analysis populations are therefore not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Exercise Intervention | 1 | 10 | 10.0% |
| Standard Care Control Group | 1 | 11 | 9.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Exercise Intervention | 1 of 10 |
| Standard Care Control Group | 0 of 11 |
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 |
|---|---|
| Exercise Intervention | 6 of 10 |
| Standard Care Control Group | 7 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Exercise Intervention | Standard Care Control Group |
|---|---|---|---|
| Hospitalization | Renal and urinary disorders | 0 of 10 | 1 of 11 |
| Death | General disorders | 1 of 10 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Exercise Intervention | Standard Care Control Group |
|---|---|---|---|
| Musculoskeletal pain or associated issues | Musculoskeletal and connective tissue disorders | 2 of 10 | 4 of 11 |
| Urinary tract or kidney associated issues | Renal and urinary disorders | 0 of 10 | 2 of 11 |
| Respiratory issues | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 1 of 11 |
| Cardiac issues | Cardiac disorders | 1 of 10 | 1 of 11 |
| Infections (non-UTI/respiratory) | Infections and infestations | 1 of 10 | 1 of 11 |
| Falls or injuries | Injury, poisoning and procedural complications | 1 of 10 | 1 of 11 |
| Fatigue/malaise/dizziness/nausea | General disorders | 2 of 10 | 0 of 11 |
| Eye disorders | Eye disorders | 0 of 10 | 1 of 11 |
Serious events with the highest arm-level rate: death (10.0%), hospitalization (9.1%).
The serious adverse-event summary lists 1 of 10 participants affected in the Exercise Intervention arm and 1 of 11 in the Standard Care Control Group. For other adverse events, it lists 6 of 10 and 7 of 11 participants affected, respectively. These are affected-participant counts, distinct from the primary endpoint's total event counts of 11 and 16. The record also lists 1 death in the exercise arm and 0 in standard care. Death and Hospitalization are named as top serious terms, with 10.0% and 9.1% recorded beside them.
These figures are descriptive registry entries, not a statistical comparison. No uncertainty estimates or tests are reported for these categories. The record does not explain whether people could have multiple events, whether serious-event terms overlap, or how the listed percentages were defined. The death count and the serious-term percentage should not be assumed to represent different or equivalent measures without those definitions.
In general, serious-event summaries need context about event definitions, timing, relatedness, follow-up, and exposure. Those details are not reported in the registry record. The arm counts should therefore be read as the recorded safety information, not as proof of a difference in safety between groups.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, parallel study comparing a home-based digital exercise program with standard care among older sepsis survivors. It reports enrollment of 21 and a primary safety endpoint defined as adverse-event counts from baseline to 3 months. The posted values are 11 events in the exercise arm and 16 in the standard care arm. Separate safety summaries report serious and other adverse events affecting participants, as well as death counts and serious-event terms.
Those figures describe what is posted, but they do not provide a quantified treatment effect or its precision. There is no reported confidence interval, statistical test, or analysis model for the primary outcome. The registry record marks the count endpoint as not estimable for a two-arm comparison, and it lists no analysis entries. The observed totals alone do not establish a difference in event burden or explain whether any difference would be attributable to assigned treatment.
The trial's motivation includes improving physical function after sepsis, but the primary endpoint is safety. Although the 30-second Sit-to-Stand Test and 4-Stage Balance Test are named as secondary outcomes, their results are not posted in the registry record. No conclusion about physical function follows from the reported primary safety counts.
These data do not establish that the digital exercise program works, does not work, is safer, or is less safe than standard care. They also do not show whether the program was followed as intended, how standard care was delivered, or whether participants completed follow-up. A reader can use the record to understand the study's broad design and the recorded event totals, while recognizing that the comparative statistical evidence and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This study addresses a practical research question described in the registry summary: whether exercise training can be delivered remotely to older sepsis survivors who may live far from research facilities and lack access to rehabilitation services. Statistical interpretation matters because the primary outcome is a safety count, while the motivation also concerns physical function. Keeping those questions distinct prevents the safety endpoint from being mistaken for evidence about functional outcomes.
The randomized design offers a framework for comparing assigned groups, but meaningful interpretation also requires an analysis that reflects the endpoint and its uncertainty. Here, the registry lists arm-level adverse-event totals and affected-participant counts, yet does not report a two-arm inferential analysis. The record therefore illustrates why descriptive counts and comparative estimates are not interchangeable. Without an estimate and uncertainty measure, the degree of precision in a group contrast cannot be assessed.
The study's listed enrollment is 21. With a relatively limited number of participants, event summaries can be informative as a record of observed safety experience, while still leaving uncertainty about how representative the totals are of a broader population. The registry does not report a trial-specific sample-size justification, so the enrollment cannot be evaluated against a stated target effect or precision goal.
Finally, the missing analysis details are themselves relevant to statistical reading. Definitions of event counting, outcome completion, analysis populations, missing-data handling, and multiplicity procedures are not reported in the registry record. These details help determine what a comparison estimates and how robustly it can be interpreted. The record is useful for identifying the design and posted outcomes, but it does not furnish enough statistical results to resolve the comparative safety or physical-function questions.
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 posted record gives limited detail for evaluating the trial results. It lists the primary endpoint as an event count and gives arm totals, but does not report an inferential comparison, confidence interval, p-value, or analysis model. The record specifically indicates that values are not estimable for a two-arm comparison of the count-other endpoint. Consequently, the precision and statistical uncertainty of a group contrast cannot be assessed.
The record does not describe adverse-event counting rules, recurrent-event handling, event attribution, follow-up completeness, or time at risk. It also does not explain the relationship between the primary event totals and the participant counts in the serious and other adverse-event summaries. The definitions behind the top serious-event percentages are not reported in the registry record.
Participant eligibility details, baseline characteristics, intervention content, adherence, and the content of standard care are not reported. The masking implementation and allocation procedures are also not described. These omissions limit assessment of the treatment contrast and the groups' comparability beyond the randomized design label.
Only two secondary outcomes are named, while the registry indicates four outcome measures. The other measures, secondary-outcome results, multiplicity plan, missing-data approach, and analysis population are not reported in the registry record. The record also does not report a trial-specific sample-size justification or interim-analysis procedures. These gaps mean that the posted information supports a description of recorded counts and design features, but not a complete evaluation of the planned or performed statistical analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial — NCT05568511.
- Registry record last updated 2026-03-18; status last verified 2025-08.
- Results first posted 2026-03-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The HEAL Sepsis Trial, sponsored by the University of Florida, is listed as a completed, randomized, double-masked, parallel study with enrollment of 21. It compares an app-based home exercise program with standard care among older sepsis survivors, as described in the registry summary. The study dates recorded are 2023-03-29 and 2025-07-29 for start and primary completion.
The primary outcome is the number of adverse events from baseline to 3 months. The registry lists 11 events in the exercise arm and 16 in standard care, but does not report an inferential two-arm analysis. It also lists serious and other adverse-event participant counts, and names the 30-second Sit-to-Stand Test and 4-Stage Balance Test as secondary outcomes. Results for those secondary outcomes, analysis methods, missing-data procedures, and a trial-specific sample-size justification are not reported in the registry record.