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 Exercise Program For Recovery After Transcatheter Aortic Valve Replacement (NCT02805309), a randomized na study. The primary outcome is Change in the Late-Life Function and Disability Instrument (LLFDI) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02805309 |
| Phase | NA |
| Condition | Aortic Valve Stenosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 64 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Brigham and Women's Hospital |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing transcatheter aortic valve replacement (TAVR) for aortic valve stenosis. The registry summary describes the intended population as older adults with severe symptomatic aortic stenosis who were considered high risk for surgical aortic valve replacement. The record does not give further eligibility details.
Intervention
A home-based exercise program delivered during physical therapist home visits, together with cognitive behavioral interventions. Visits were to begin within 1 week of discharge. The program targeted endurance, strength, and balance.
Comparator
The randomized comparison included exercise alone and an attention control education program, as well as the combined exercise and cognitive behavioral intervention. The education program consisted of telephone-based sessions from a study health professional.
Primary question
The intended primary endpoint was change in the Late-Life Function and Disability Instrument (LLFDI) score, assessed at baseline and week 8. The registry record says the LLFDI change could not be analyzed because the software could not be run after a Windows operating system upgrade. The primary question therefore has no reported LLFDI change estimate in the registry record.
3. Trial Design
This was a randomized, single-masked, parallel pilot study of a home-based program after TAVR. The registry record lists enrollment as 64 and the status as completed. It lists the start date as 2017-08-01 and primary completion date as 2020-05-06. The identity of the masked parties is not reported in the registry record.
The intervention groups were exercise with cognitive behavioral interventions and exercise alone. A third group received an attention control education program. The exercise interventions were described as individualized and delivered in home visits by a physical therapist, beginning within 1 week of discharge. The education comparator used telephone sessions. The registry record does not report the number, length, or full schedule of sessions.
The study rationale was that patients may experience functional decline after TAVR despite symptomatic and survival benefits. Its stated aim was to test the feasibility of a home-based intervention directed at physical functioning and disability. The record does not provide a complete feasibility definition or results for such measures.
The planned primary measure was LLFDI change at baseline and week 8. Secondary outcomes included change in the Short Physical Performance Battery summary score, 2-Minute Walk Distance, and dominant hand grip strength, along with the number of participants who experienced adverse events. Although the record lists 11 outcome measures, it reports zero analyses. No arm-specific results for the functional secondary outcomes are included in the registry record.
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: 10 participants were disenrolled due to medical complications (n=5), rehabilitation facility discharge (n=2), and unavailability of the research team for assessment (n=3).
Overall Study
| Stage | Exercise & Cognitive Behavioral Int. | Exercise Alone | Attention Control Education Program |
|---|---|---|---|
| STARTED | 18 | 17 | 19 |
| COMPLETED | 16 | 13 | 16 |
| NOT COMPLETED | 2 | 4 | 3 |
Reasons for not completing this period:
| Reason | Exercise & Cognitive Behavioral Int. | Exercise Alone | Attention Control Education Program |
|---|---|---|---|
| Lost to Follow-up | 2 | 2 | 2 |
| Post-Randomization Exclusion | 0 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: The LLFDI Computer Adaptive Test software for Windows could not be run after the Windows operating system upgrade during our study period. LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks. Therefore, we were unable to analyze the LLFDI score change. Instead, we measured a disability score (count of 22 daily activities and physical tasks that a person cannot perform without another person's help) post-hoc (see post-hoc outcome measure).
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: Three patients (exercise alone n=2, attention control education n=1) were disenrolled after randomization because they developed medical complications or were discharged to a rehabilitation facility (exclusion criteria).
| Characteristic | Unit | Exercise & Cognitive Behavioral Int. | Exercise Alone | Attention Control Education Program | Total |
|---|---|---|---|---|---|
| Participants analysed | 18 | 15 | 18 | 51 | |
| Age, Continuous | years | 85.1 (SD 9.1) | 84.9 (SD 5.1) | 82.8 (SD 8.0) | 84.2 (SD 7.6) |
| Sex: Female, Male: Female | Participants | 9 | 1 | 9 | 19 |
| Sex: Female, Male: Male | Participants | 9 | 14 | 9 | 32 |
| 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 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 18 | 15 | 17 | 50 |
| 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 | 18 | 15 | 18 | 51 |
| New York Heart Association Class 3-4 | Participants | 8 | 9 | 6 | 23 |
| Aortic valve area | cm^2 | 0.79 (SD 0.21) | 0.80 (SD 0.22) | 0.80 (SD 0.20) | 0.80 (SD 0.20) |
| Left ventricular ejection fraction | % | 60.6 (SD 9.4) | 57.0 (SD 8.1) | 56.1 (SD 15.6) | 58.0 (SD 11.6) |
| Body mass index | kg/m2 | 27.5 (SD 6.4) | 27.9 (SD 4.8) | 30.6 (SD 6.3) | 28.7 (SD 6.0) |
| At risk of malnutrition | Participants | 8 | 4 | 6 | 18 |
| Mini-Mental State Examination score | units on a scale | 25.8 (SD 3.0) | 25.8 (SD 3.0) | 25.4 (SD 4.0) | 25.7 (SD 3.3) |
| Activities of daily living dependence | Participants | 1 | 2 | 1 | 4 |
| Instrumental activities of daily living dependence | Participants | 6 | 7 | 9 | 22 |
| Gait speed | meter/second | 0.73 (SD 0.29) | 0.65 (SD 0.25) | 0.58 (SD 0.23) | 0.65 (SD 0.26) |
6. Primary Endpoint
The registry lists the primary outcome as Change in the Late-Life Function and Disability Instrument (LLFDI) Score, measured over At baseline and week 8.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The planned primary endpoint was change in the Late-Life Function and Disability Instrument (LLFDI) score, measured at baseline and week 8. The LLFDI is a patient-reported questionnaire intended to capture aspects of functioning that may matter in daily life after a major procedure. Its Activity Limitation domain concerns difficulty performing physical tasks; its Participation Restriction domain concerns difficulty carrying out major life tasks and social roles. The domains are analyzed separately, and each has a range of 0-100. Higher values indicate better function, meaning lower limitation or disability.
These domains address related but distinct experiences: ability to perform physical tasks and participation in life roles. Measuring both can offer a broader account of function than a single measure of physical performance. Patient-reported measures also capture the participant’s perspective rather than relying only on a performance test.
The endpoint’s intended use does not establish that a change was measured or observed. The registry record states that LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks. Because the LLFDI software could not be run after a Windows operating system upgrade during the study period, the investigators were unable to analyze score change. No LLFDI change estimate is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the planned primary endpoint was not analyzed. The registry record describes LLFDI change between baseline and week 8, but reports that scores were available for 36 participants at baseline and 10 participants at 8 weeks. It attributes the inability to analyze change to a software problem following a Windows operating system upgrade. No mean change, uncertainty interval, test result, or arm comparison for LLFDI is reported. Consequently, the posted results do not quantify the primary functional outcome.
The record also lists several secondary outcomes, including physical performance, walking distance, grip strength, and adverse events. It does not report analyses for the functional secondary outcomes. The record lists 11 outcome measures and zero analyses; this means that the registry record does not provide analyzed results for those measures. It does not establish whether analyses were performed elsewhere or whether additional results exist outside the registry record.
The adverse-event information is descriptive. Serious adverse events were reported for 1 participant in the exercise and cognitive behavioral intervention group, 2 in the exercise-alone group, and 1 in the attention control education group. Other adverse events were reported for 12, 8, and 8 participants in those groups, respectively. Deaths were reported as 0 in each group. These counts describe the posted record; they do not provide an adjusted comparison or establish that the groups differed. The registry record does not report definitions, event-level timing, or an inferential analysis for these figures.
The absence of a reported LLFDI estimate is not evidence that the interventions had no effect, nor does it establish that they improved function. There is no primary-outcome estimate in the record to assess the direction or precision of an effect. The study’s pilot purpose and the availability problem are important context, but neither supplies the missing treatment comparison.
For readers considering the numerical adverse-event entries, a count is a description of events or participants as categorized in the record, not a measure of causal attribution. The registry does not indicate which events were considered related to the intervention. The listed serious-event terms and percentages also do not replace a full account of definitions, timing, overlap, or clinical review.
9. Statistical Methods Explained
What would a mean change describe?
The registry identifies the primary measure as a mean of a continuous score, with standard deviation as the dispersion measure. In general, a mean summarizes the central value of observed scores, while a standard deviation describes how spread out individual scores are around that mean. For a change endpoint, a mean change would summarize the direction and typical size of score changes over the stated assessment period. The standard deviation would describe variability in those individual changes. Neither a mean nor a standard deviation is reported for LLFDI change in this registry record.
What would an uncertainty interval contribute?
In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical procedure. It can show which effect sizes are compatible with the observed data and method. A narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave the direction uncertain. The registry record does not report a confidence interval for LLFDI change, and no interval can be inferred from the available description.
Why are the LLFDI domains separate?
The LLFDI description distinguishes Activity Limitation from Participation Restriction. The former concerns physical tasks; the latter concerns major life tasks and social roles. Since these are distinct domains with separate scores, interpreting one would not automatically answer the question addressed by the other. The record says the domains are analyzed separately and that higher scores indicate better function for both. It does not report analyzed changes for either domain.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable at the outset with respect to both measured and unmeasured characteristics, on average. This supports a causal comparison when outcomes are collected and analyzed appropriately. Randomization alone does not guarantee that outcome data are complete, that groups remain comparable in the observed data, or that an effect estimate is precise. Here, the main planned outcome could not be analyzed, so the registry record does not present a randomized comparison of LLFDI change.
What can be said about masking?
The record identifies the study as single-masked but does not identify who was masked or how masking was maintained. General discussions of masking often consider whether participants, clinicians, outcome assessors, or analysts knew group assignments; the registry record does not specify which applied. It is therefore not possible to assess masking procedures beyond the single-masked designation.
How should the event counts be read?
In general, adverse-event counts are descriptive unless accompanied by a clear event definition, a specified observation period, and a statistical comparison suited to the outcome. Serious events and other events are separate categories in the posted record. The participant counts reported for these categories should not be treated as a randomized treatment-effect estimate. The record does not report an inferential comparison or specify whether events could be counted in more than one category.
What do the planning assumptions mean?
The registry record describes sample-size planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that time-to-event illustrations use total event counts, while other illustrations use participants per arm. These are planning assumptions, not a description of the trial’s original design and not observed power. No numerical planning estimates are reported in the registry record. The record does not report the trial’s sample-size justification or a statistical analysis plan.
Why does over-dispersion matter in general?
For outcomes recorded as counts, some statistical models assume a particular relationship between the average count and its variability. Over-dispersion means that observed variability exceeds what that assumption allows. If it is ignored, uncertainty estimates can be too small and statistical evidence can appear stronger than warranted. This is a general consideration, not a reported feature of this trial: the registry record does not describe a count model or an analysis of event rates.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 11 outcome measures and zero analyses. It also states that the primary outcome has several categories or time points and is not reduced to one comparison. For LLFDI, the two domains are analyzed separately, and the planned assessment included baseline and week 8. The record does not identify a single reported treatment contrast or provide an analysis for either domain.
When a study examines multiple outcomes, domains, time points, or group comparisons, the chance of at least one apparently notable result can increase if each is tested separately. General approaches to multiplicity include prespecifying a primary comparison, adjusting tests, or interpreting secondary analyses as exploratory. Which approach was planned or used is not reported in the registry record. No correction method or hierarchy of outcomes is described, so no claim about control of multiplicity is supported.
The record identifies a specific data-availability problem for LLFDI: scores were available for 36 participants at baseline and 10 participants at 8 weeks, and the change could not be analyzed because the software could not be run after a Windows operating system upgrade. This is a documented limitation of outcome availability. The record does not report how missing scores were handled statistically, whether any imputation was attempted, or whether other analyses were used.
Analysis populations, such as an intention-to-treat population or a per-protocol population, are not reported in the registry record. The record also does not report reasons for missing data beyond the software issue, or a comparison of participants with and without available scores. These omissions limit assessment of selection and missing-data bias. They do not establish that any particular bias occurred, but they leave its direction and size unresolved.
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 & Cognitive Behavioral Int. | 1 | 18 | 5.6% |
| Exercise Alone | 2 | 15 | 13.3% |
| Attention Control Education Program | 1 | 18 | 5.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Exercise & Cognitive Behavioral Int. | 0 of 18 |
| Exercise Alone | 0 of 15 |
| Attention Control Education Program | 0 of 18 |
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 & Cognitive Behavioral Int. | 12 of 18 |
| Exercise Alone | 8 of 15 |
| Attention Control Education Program | 8 of 18 |
Most frequent serious adverse event terms
| Event term | Organ system | Exercise & Cognitive Behavioral Int. | Exercise Alone | Attention Control Education Program |
|---|---|---|---|---|
| Chest pain | Cardiac disorders | 0 of 18 | 1 of 15 | 0 of 18 |
| Diarrhea | Gastrointestinal disorders | 1 of 18 | 0 of 15 | 0 of 18 |
| Dizziness | Nervous system disorders | 0 of 18 | 1 of 15 | 0 of 18 |
| Hallucination | Psychiatric disorders | 0 of 18 | 1 of 15 | 0 of 18 |
| Heart failure | Cardiac disorders | 0 of 18 | 0 of 15 | 1 of 18 |
| Epistaxis | Blood and lymphatic system disorders | 1 of 18 | 0 of 15 | 0 of 18 |
| Seizure | Nervous system disorders | 0 of 18 | 0 of 15 | 1 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Exercise & Cognitive Behavioral Int. | Exercise Alone | Attention Control Education Program |
|---|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 5 of 18 | 3 of 15 | 3 of 18 |
| Chest pain | Cardiac disorders | 3 of 18 | 1 of 15 | 2 of 18 |
| Fatigue | General disorders | 3 of 18 | 1 of 15 | 2 of 18 |
| Dizziness | Nervous system disorders | 2 of 18 | 2 of 15 | 1 of 18 |
| Fall | Injury, poisoning and procedural complications | 1 of 18 | 1 of 15 | 1 of 18 |
| Abnormal blood test | Investigations | 1 of 18 | 0 of 15 | 1 of 18 |
| Elevated blood pressure | Cardiac disorders | 1 of 18 | 1 of 15 | 0 of 18 |
| Leg swelling | Cardiac disorders | 1 of 18 | 1 of 15 | 0 of 18 |
| Abdominal pain | Gastrointestinal disorders | 1 of 18 | 0 of 15 | 0 of 18 |
| Angina | Cardiac disorders | 0 of 18 | 1 of 15 | 0 of 18 |
Serious events with the highest arm-level rate: chest pain (6.7%), dizziness (6.7%), hallucination (6.7%), diarrhea (5.6%), heart failure (5.6%).
The registry record gives serious and other adverse-event participant counts separately for each randomized group. Serious adverse events were reported for 1 participant in the exercise and cognitive behavioral intervention group, 2 participants in the exercise-alone group, and 1 participant in the attention control education group. Other adverse events were reported for 12, 8, and 8 participants in those groups, respectively. Deaths were recorded as 0 in each group.
The record also lists serious adverse-event terms with percentages: chest pain, dizziness, and hallucination at 6.7% each; diarrhea, heart failure, and epistaxis at 5.6% each. These entries are descriptive. The registry record does not give enough detail to determine from these figures whether terms represent unique participants, repeated events, or events that overlap with other terms.
Counts alone do not establish that the intervention caused an event or that one group had more risk than another. The registry record does not report event attribution, definitions, observation duration, or a statistical comparison. The figures should therefore be read as reported safety counts, not as evidence for a causal difference between groups.
12. What the Result Does, and Does Not, Mean
This record documents a randomized pilot study of home-based exercise after TAVR, including an exercise program with cognitive behavioral interventions, exercise alone, and telephone-based education. Its planned primary measure concerned patient-reported function and disability at baseline and week 8. The record explains why that outcome could not be analyzed: a software problem followed a Windows operating system upgrade, and LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks.
Without a reported LLFDI change estimate, there is no primary-outcome effect size to interpret, and no confidence interval to indicate its precision. The record therefore cannot establish from this outcome whether function changed differently among groups. It also cannot establish that there was no difference: missing analysis is not the same as a finding of no effect.
The listed adverse-event counts offer a descriptive account, but do not resolve whether events were related to an intervention or whether group differences are compatible with chance. The record reports deaths as 0 in each group, but that entry alone does not characterize all aspects of safety. Definitions, follow-up details, and formal comparisons are not reported.
In general, a pilot study can inform whether an intervention and its evaluation are feasible, and can help shape later research. However, the registry record does not report a full set of feasibility outcomes or a statistical plan, and it does not provide numerical planning estimates. It is not possible to infer the success of the intervention, the expected effect in a future study, or the adequacy of the study’s original sample size from the posted results.
The appropriate reading is bounded by what the record actually reports: the trial was completed, the intended primary measure could not be analyzed, and adverse-event counts are listed by group. Conclusions about comparative functional effects or causal safety differences are not supported by these registry entries.
13. Why This Trial Matters Statistically
This trial is statistically instructive because the primary question and the reported evidence do not align. The investigators intended to evaluate patient-reported functional change after TAVR, using a measure with separate activity and participation domains. Yet the registry record says a technical problem prevented analysis of that change. A clearly described endpoint is not enough to support an interpretation when the relevant outcome data cannot be analyzed.
The case also highlights why outcome availability is part of statistical validity, not merely a reporting detail. Scores were available for 36 participants at baseline and 10 participants at week 8. Without an analyzed change estimate and further information about data availability, readers cannot assess the direction, magnitude, or precision of the intended primary comparison. The cause of the missing analysis is documented, but the consequences for group comparability cannot be determined from the registry record.
The three-arm structure makes the identity of the intended comparison important. Exercise was tested with and without cognitive behavioral interventions, alongside an attention control education program. A result comparing one group with another would answer a different question from a comparison using a different reference group. The registry record does not report a specific analyzed functional contrast.
Finally, the record is a reminder that descriptive safety counts are not substitutes for comparative analyses, and that the presence of a sample-size planning illustration does not mean the study was powered to detect a particular effect. The record’s planning assumptions are explicitly illustrative rather than a description of the trial’s own design. Clear reporting of outcomes, missingness, analysis populations, and planned contrasts is necessary for readers to understand what evidence a trial contributes.
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 most direct limitation is that the planned primary LLFDI change was not analyzed. The registry record attributes this to the inability to run the LLFDI software after a Windows operating system upgrade during the study period. LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks. The record does not report a replacement primary analysis or explain what appears after the truncated phrase “Instead,” so no alternative primary result can be identified.
Although the record lists functional secondary outcomes, it reports zero analyses. There are no reported changes for the Short Physical Performance Battery, 2-Minute Walk Distance, or dominant hand grip strength. The record therefore does not permit comparison of these functional outcomes across the randomized groups.
Important analysis details are not reported in the registry record, including the analysis population, missing-data methods, prespecified contrasts, multiplicity approach, and statistical analysis plan. The record identifies the study as single-masked but does not identify who was masked. It also does not give detailed schedules or dosage for the home visits and telephone sessions.
Safety reporting is limited to participant counts, deaths, and a list of serious-event terms with percentages. Definitions, event attribution, timing, and inferential comparisons are not reported. The counts are therefore not sufficient to assess causal safety differences.
These limitations constrain interpretation of the registry record; they do not establish that unreported analyses or information do not exist elsewhere. The conclusions should remain limited to the outcomes and details actually recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement — NCT02805309.
- Registry record last updated 2021-07-21; status last verified 2021-06.
- Results first posted 2021-07-21.
- 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
NCT02805309 is a completed, randomized, single-masked, parallel pilot study of a home-based exercise program after TAVR. Enrollment is listed as 64. The intervention groups received exercise with cognitive behavioral interventions or exercise alone; the attention control group received telephone-based education.
The planned primary endpoint was LLFDI change at baseline and week 8. The registry record states that this change could not be analyzed because of a software problem after a Windows operating system upgrade. It reports LLFDI scores for 36 participants at baseline and 10 participants at 8 weeks. The record lists 11 outcome measures and zero analyses. Adverse-event counts and deaths are reported by group, but no statistical comparison is included.