Improving Physical Activity With Cognitive Impairment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Physical Activity With Cognitive Impairment (NCT05370118), a randomized na study. The primary outcome is TPAB Intervention Participant Retention.

2. Clinical Question

The study addresses a feasibility question as well as preliminary physical-activity improvement. Its brief summary describes physical inactivity as a modifiable risk factor and presents activity promotion as a motivation for developing an intervention for people with amnestic mild cognitive impairment. However, the primary posted outcome is retention, not change in physical activity or a measure of cognitive progression.

The study was randomized and parallel, with a single masking designation in the record. The record does not identify who was masked. The brief summary describes planned recruitment of 30 dyads and randomization to the intervention or usual care, but posted enrollment is 16. The registry record does not explain this difference. The posted primary outcome counts are five intervention patients and five intervention care partners, and three control patients and three control care partners. Those values describe the reported retention outcome; they should not be read as a treatment-effect estimate.

3. Trial Design

This is a randomized, parallel-group pilot study sponsored by Creighton University. The registry lists the phase as NA and the masking designation as single. It does not specify who was masked, how masking was maintained, or whether allocation concealment was used. Random allocation is recorded, but further details of sequence generation and allocation procedures are not reported in the registry record.

The intervention is named the telerehabilitation physical activity behavioral (TPAB) intervention. Its description says participants attend a weekly session with their primary caregiver and a research interventionist for 12 weeks. The brief summary describes a mobile-health technology behavior-change intervention. The control group is described as receiving usual care and no intervention over the same 12 weeks. The registry record does not provide a complete protocol description in the posted arm text.

The study record lists a start date of 2023-02-01, a primary completion date of 2025-06-30, and a status of completed. The posted enrollment is 16. In contrast, the brief summary describes a plan to recruit 30 dyads, with 15 dyads assigned to each group. The record does not explain whether the planned recruitment target changed, why the posted enrollment differs, or how many dyads were initially randomized.

Results are reported separately for patients and care partners in the intervention arm, and separately for patients and care partners in the control arm. For the primary retention outcome, the registry posts counts of five for intervention patients, five for intervention care partners, three for control patients, and three for control care partners. These are not a single patient-only outcome or a pooled dyad-level result. The registry lists six outcome measures, one posted secondary outcome, and one analysis. The listed secondary outcome is change in average daily steps. A full statistical analysis plan, follow-up schedule beyond the stated outcome timing, and details of analysis populations are not reported 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.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as TPAB Intervention Participant Retention, measured over The outcome will be reported at the end of the 12 week intervention..

The primary outcome is titled “TPAB Intervention Participant Retention.” It is defined as the number of participants who complete the 12-week intervention, with reporting at the end of that intervention. The measure is a count of participants, not a continuous measure such as activity level and not a direct measure of cognitive change.

Retention is used in a pilot study to describe whether participants remain engaged through the intervention period. This can inform the practical feasibility of delivering the program and completing planned sessions or assessments. As a general statistical point, a count is most informative when its population and denominator are clear: a count alone does not show the proportion completing, and a comparison between groups also needs an interpretable definition of who was assigned and analyzed. No retention proportion is calculated.

The posted values are organized by participant role and trial arm: five intervention patients, five intervention care partners, three control patients, and three control care partners. The registry does not report a two-arm comparative estimate for this binary endpoint; its record indicates that values were missing or not estimable for such a comparison. It also does not provide a confidence interval or a p-value for retention. The available counts therefore describe the reported outcome, but do not establish the precision of a between-group difference.

Average daily steps is listed as a secondary outcome, but no result for that outcome is included in the posted results described in the record. Retention should not be treated as evidence of change in physical activity: these are distinct outcomes, measured in different ways.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization assigns participants to study groups by chance, which is intended to reduce systematic differences between groups at the point of assignment. It does not guarantee that small groups will be alike in every relevant respect. This record identifies the study as randomized and parallel, but does not report the randomization sequence method, allocation concealment, or the characteristics of participants by group. The masking designation is single; who was masked and how masking was implemented are not reported in the registry record.

What does a count outcome tell the reader?

The primary measure is a count of participants completing the 12-week intervention. A count reports how many people met the defined outcome in a group. It differs from a proportion, which relates the count to a denominator, and from a comparative effect, which contrasts groups using a defined measure. The posted result gives separate counts for patients and care partners, rather than one pooled result for dyads. The registry record does not report a two-arm comparison estimable from the posted values. It therefore does not support a calculated effect estimate for retention.

For a binary outcome, each participant is classified according to whether the event occurred. In this study, the outcome description defines completion as the event. A comparative analysis would need an unambiguous definition of the analysis groups and their denominators, as well as the outcome status for each relevant participant. The record says the values were missing or not estimable for a two-arm comparison. No statistical method for such a comparison is reported, so the reason a comparison could not be estimated cannot be specified from the registry record.

How should uncertainty be understood?

An estimate is a summary of the observed data; uncertainty describes how much that estimate might vary under repeated sampling and the assumptions of the analysis. A confidence interval is a general way to express uncertainty around an estimate. It does not guarantee that the true value lies in the interval, and its interpretation depends on the method and assumptions used. The registry record does not post a confidence interval or comparative estimate for retention. Thus, the precision of any difference between TPAB and usual care cannot be evaluated from the posted primary outcome.

A p-value, in general, measures how incompatible the observed data are with a specified null model, assuming that model and the analysis assumptions hold. It is not the probability that a treatment works, nor does it convey the size or practical importance of an effect. No p-value for the retention comparison is reported. The record does not report a hypothesis test for the primary outcome, so no statistical-significance conclusion is available.

Why does the pilot context matter?

The brief summary describes the project as a pilot and names feasibility and preliminary physical-activity improvement as aims. Pilot studies can provide descriptive information about recruitment, retention, delivery, and outcome measurement. They may also help plan later studies, but a small pilot is not automatically designed to estimate an effect precisely. Here, the record does not report a sample-size justification, target precision, or a statistical power calculation for the primary outcome. Those design details are not reported in the registry record.

The enrollment is 16. The brief summary describes planned recruitment of 30 dyads, while the posted primary outcome is reported by patient and care-partner role in both arms. The registry record does not explain the difference between planned and posted enrollment or fully document the number randomized, the number assessed, and the number with missing outcome data. This makes it difficult to reconstruct participant flow or determine how the outcome counts relate to all enrolled participants.

What is and is not available for the secondary outcome?

Change in average daily steps is named as a secondary outcome, but the record does not include a result for it among the posted results. No analysis method, estimate, uncertainty interval, or timing details for that secondary result are reported in the registry record. Without the result, the effect on activity cannot be interpreted statistically.

General statistical practice distinguishes prespecified outcomes and analyses from analyses chosen after viewing results. A statistical analysis plan can clarify the outcome definitions, time points, analysis populations, handling of missing data, and adjustment for multiple comparisons. The record does not report a complete statistical analysis plan or enough detail to assess these choices. There is no basis in the record to infer interim analyses, sample-size recalculation, covariate adjustment, or other modeling decisions.

For a count outcome, the analysis can also depend on whether the goal is simply to report totals, compare proportions, or model a count process. These approaches answer different questions and require different assumptions. No such modeling details are reported for retention. In particular, the presented counts should not be converted into a rate or relative effect without a clear denominator and specified analysis.

The record includes no planning sample-size illustration for a retention comparison in the registry entries described. More generally, a sample-size calculation is a design exercise based on assumptions about an effect, variability, allocation, and error rates. It is not an observed result and cannot supply evidence that an outcome effect occurred. The registry record does not report the assumptions behind its original recruitment plan.

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.

R code and output

arm    <- c("Telerehabilitation Physical Activity Behavioral (T", "Telerehabilitation Physical Activity Behavioral (T", "Control Group - Patient", "Control Group - Care Partner")
n      <- c(5, 5, 3, 3)
events <- c(5, 5, 3, 3)
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  Telerehabilitation Physical Activity Behavioral (T  5  5  100.0  47.8  100.0  56.6  100.0  54.1  99.6
ARM  Telerehabilitation Physical Activity Behavioral (T  5  5  100.0  47.8  100.0  56.6  100.0  54.1  99.6
ARM  Control Group - Patient  3  3  100.0  29.2  100.0  43.9  100.0  39.8  99.4
ARM  Control Group - Care Partner  3  3  100.0  29.2  100.0  43.9  100.0  39.8  99.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, one posted secondary outcome, and one analysis. The primary outcome is retention, and change in average daily steps is listed as a secondary outcome. A complete hierarchy of outcomes, the prespecified analysis plan, and any adjustment for multiple comparisons are not reported in the registry record. Multiplicity matters in general because testing several outcomes or time points can increase the chance of finding an apparently notable result by chance. The record does not say whether or how this issue was addressed.

The primary outcome result is reported as counts by patient and care-partner role and arm. A two-arm comparison is marked as missing or not estimable. The record does not explain whether this arose from unavailable values, the structure of the reported groups, or another reason. Missing outcome data, withdrawals, exclusions, and analysis populations are not described. It is therefore not possible to determine whether the posted counts include everyone randomized or only participants with observed completion status.

General statistical practice distinguishes an intention-to-treat population, based on assigned groups, from populations defined by treatment received or outcome availability. Which population was used is not reported in the registry record. The record also does not state how missing outcomes were handled, whether any participants were excluded from analysis, or whether sensitivity analyses were conducted. These omissions limit interpretation of the retention counts and prevent assessment of whether missingness could affect a comparison.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: collapsed lung (20.0%), surgery for collapsed lung (20.0%).

The registry reports serious adverse events for intervention patients, intervention care partners, control participants, and control care partners separately. One of five intervention patients is recorded as affected by a serious adverse event. No serious adverse events are reported for intervention care partners, control participants, or control care partners. The record reports zero deaths in each listed group.

The serious adverse-event terms listed are “Collapsed Lung” and “Surgery for Collapsed Lung,” each reported as 20.0%. The registry does not clarify whether these are separate events, related descriptions, or terms associated with the same participant. No additional event-level timing, attribution, or clinical detail is reported in the registry record.

The record also reports one intervention patient with another adverse event, with zero affected participants reported for the other listed groups. Safety counts are descriptive. Because the groups are small and the record does not provide a comparative safety analysis, these figures do not establish whether the intervention changes risk. A zero count means no affected participant was reported in that group; it does not prove that an event could not occur.

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

The results show reported retention counts at the end of the 12-week intervention: five intervention patients, five intervention care partners, three control patients, and three control care partners. They do not provide an estimable two-arm comparison for the primary binary endpoint. The counts therefore describe what is posted but do not quantify how retention differed between TPAB and usual care, or how precisely any difference might be estimated.

The study's stated motivation concerns physical activity in people with amnestic mild cognitive impairment. However, retention is the primary outcome, and change in average daily steps is the listed secondary outcome. A retention count does not measure activity. The record does not post a result for average daily steps, so it cannot establish whether activity changed. The record also does not report a cognitive outcome result, and it does not support conclusions about progression to dementia or Alzheimer's disease.

The study is described as a pilot, and the brief summary discusses feasibility and preliminary improvement. The posted enrollment is 16, whereas the summary describes planned recruitment of 30 dyads. The reason for that difference is not reported in the registry record. Along with the absence of an estimable retention comparison and missing details about participant flow and analysis, this limits what can be learned from the counts.

The safety record reports one intervention patient with a serious adverse event and one with another adverse event, with no deaths reported. These observations are not a comparative safety estimate. Overall, the results are descriptive and do not establish a treatment effect, the absence of an effect, or the precision of a between-group difference. Any broader inference would require outcome data and analysis details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial raises statistical questions that often arise in early-stage clinical research: whether recruitment and retention can be described clearly, whether outcomes align with the study's aims, and whether results support a comparison between randomized groups. The registry identifies retention as the primary outcome and reports counts split by patient and care-partner roles. That distinction matters because patient-level and caregiver-level counts do not automatically represent a single dyad-level outcome.

The study summary describes planned recruitment of 30 dyads, while the registry reports enrollment of 16. Reporting the difference and participant flow would help readers understand the scale of the study and the relationship between the recruitment plan, randomization, and observed outcomes. The registry record does not give that explanation. Similarly, an explicit denominator and a comparison estimate would make a retention result easier to interpret than counts alone.

The gap between the stated focus on physical activity and the primary retention endpoint is also important. Feasibility and activity change are related but distinct questions. A study can report retention without establishing whether activity changed, and the listed secondary activity outcome has no posted result in the record. Clear outcome reporting helps prevent a process measure from being mistaken for a clinical or behavioral effect.

Finally, the record illustrates why uncertainty and analysis details matter alongside observed results. Randomization is valuable, but it does not by itself provide an effect estimate, confidence interval, or explanation of missing data. The available information supports a descriptive reading of a small pilot, not a precise comparative conclusion.

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.

The posted enrollment is 16, while the brief summary describes a plan to recruit 30 dyads. The reason for the discrepancy is not reported in the registry record. Counts are posted separately for patients and care partners, but a full account of the number randomized, the number completing follow-up, withdrawals, and missing outcome status is not reported. This limits the ability to reconstruct participant flow or identify the denominator for each count.

The record does not provide an estimable two-arm comparison for the primary binary endpoint, nor does it report a confidence interval or p-value. Details of the randomization method, allocation concealment, masking roles, statistical analysis plan, analysis populations, and missing-data procedures are also not reported. These omissions prevent assessment of how the reported counts were generated and how precise a comparative result might be.

The record lists change in average daily steps as a secondary outcome but does not post its result. It also does not report a complete description of the intervention in the arm text, or specify the planned outcome-assessment procedures beyond the stated retention time point. The registry record does not report a sample-size justification or the rationale for the original recruitment target. As a pilot, the study may be useful for descriptive feasibility information, but the available results do not support a precise estimate of a treatment effect.

Safety information is also limited to the posted affected-participant counts and terms. The record does not clarify whether “Collapsed Lung” and “Surgery for Collapsed Lung” refer to separate events or related descriptions. Event timing, attribution, and detail are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Improving Physical Activity With Cognitive Impairment — NCT05370118.
• Registry record last updated 2026-05-14; status last verified 2025-08.
• Results first posted 2026-05-14.
• 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.

19. Record Summary

NCT05370118, “Improving Physical Activity With Cognitive Impairment,” is a completed, randomized, parallel pilot study sponsored by Creighton University. The record lists a single masking designation, an enrollment of 16, a start date of 2023-02-01, and a primary completion date of 2025-06-30.

The intervention is a 12-week telerehabilitation physical activity behavior-change program, compared with usual care. The primary outcome is the number of participants completing the intervention. Posted counts are five intervention patients, five intervention care partners, three control patients, and three control care partners. A two-arm comparison for the binary endpoint is not estimable in the posted results. Change in average daily steps is listed as a secondary outcome, but no result is reported. The registry also records one serious adverse event in an intervention patient and no deaths in the listed groups.

The record does not explain the difference between posted enrollment and the recruitment target described in its summary. Statistical analysis, missing-data, and participant-flow details are limited.