At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's (NCT04512040), a na na study. The primary outcome is Attendance.

2. Clinical Question

The central question is whether at-home yoga delivered by telehealth can be implemented for people living with Alzheimer disease and chronic musculoskeletal pain, together with their caregivers. The registry describes the study as a feasibility evaluation. Its primary outcome focuses on participation in the classes, rather than directly measuring pain relief or another clinical benefit.

The registry record lists enrollment of 30 and marks the study completed. It does not report a numerical attendance result, a pain outcome result, or an analysis estimate. Consequently, the question that can be framed from the record is about the feasibility outcome the study intended to assess, not about a measured treatment effect.

3. Trial Design

The study is registered as a completed feasibility study of at-home telehealth yoga for chronic pain in people with Alzheimer disease and their caregivers. The intervention is behavioral, and the record describes yoga classes delivered at home by video conferencing through a tablet computer. It identifies a single-group model, with no randomized allocation and no masking.

The registry lists enrollment of 30. It gives a start date of 2021-02-25 and a primary completion date of 2022-05-09. The record does not report a separate control condition or a randomized comparison. Its designation as completed describes the study status in the registry; it does not itself indicate that outcome results were posted.

The arm description refers to yoga for Alzheimer disease patients and caregivers, initially delivered in a one-to-one format between the yoga therapist and the dyad. It also contains a passage describing five outpatient adults with chronic musculoskeletal pain and mild Alzheimer disease and their caregivers. The description then trails off while discussing later delivery. The registry record does not explain how that passage relates to the enrollment of 30 or to the final delivery of the program.

The primary outcome is attendance, expressed as the percentage of classes attended during 12 weeks. The registry lists two outcome measures, but the other measure and its result are not reported in the registry record. It lists no analyses. The posted information therefore supports a description of the intended feasibility design, but not a reconstruction of the completed study’s analysis or its findings.

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 Attendance, measured over 12 weeks.

The primary endpoint is attendance, defined as the percentage of classes attended during 12 weeks of treatment. It is a continuous measure, and the record identifies the mean and standard deviation as its intended summary. Attendance is relevant to feasibility because it describes whether participants take part in the scheduled intervention. For a home-based program involving people with Alzheimer disease and caregivers, participation is an important aspect of whether the delivery approach can be carried out.

Attendance is not a direct measure of pain intensity, pain interference, or change in health. A high or low attendance value would describe participation, not by itself the effect of yoga on pain. Interpreting attendance also depends on knowing how many classes were offered, how attendance was recorded, whether participants could miss or discontinue classes, and how missing attendance records were handled. Those details are not reported in the registry record.

No numerical mean, standard deviation, or other attendance result is reported in the registry record. Thus, the endpoint’s definition and timeframe can be described, but the observed level of attendance and its precision cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

A continuous endpoint is measured on a scale where values can vary across a range. The registry classifies attendance as continuous and specifies a mean with a standard deviation. In general, the mean describes the average observed value, while the standard deviation describes how spread out individual values are around that average. Neither quantity is reported for attendance in the registry record, so the distribution and its variability cannot be evaluated.

What a confidence interval would tell readers

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrower interval indicates greater precision for that estimate, while a wider interval indicates more uncertainty. The record does not report an attendance estimate or confidence interval. It is therefore not possible to describe precision from the posted results or to infer it from the enrollment number alone.

Why the single-group structure matters

The registry identifies the model as single-group and allocation as NA. In general, a single-group study can describe what happened among participants who received the intervention, but it does not provide a concurrent control group for estimating what would have happened without that intervention. A comparison to an external or historical group would require information and assumptions not described in this record. No such comparison is reported. The lack of masking is also listed; the record does not describe procedures that might reduce awareness of treatment or outcome status.

Interpreting attendance as a feasibility measure

Attendance can help describe whether people participate in an intervention delivered in their homes. In general, a feasibility measure answers a different question from an efficacy measure: it concerns implementation and participation rather than whether an intervention changes a health outcome. Attendance may be influenced by scheduling, access to technology, caregiver availability, health, and other factors. These are general possibilities, not explanations established for this study. The registry record does not report the reasons for missed classes or the number of classes offered.

Over-dispersion and count outcomes

General statistical note: over-dispersion occurs when variation in count data is greater than a model expects. It can make standard errors too small if the model does not account for that extra variation. This concept is not a reported feature of the primary endpoint in this record: attendance is specified as a percentage with a mean and standard deviation, and no model or count analysis is reported. It would not be appropriate to assert that over-dispersion occurred in this study.

What the analysis record does not establish

The registry lists two outcome measures and zero analyses. The specific analysis methods, analysis populations, adjustment variables, and handling of missing observations are not reported in the registry record. No p-value, confidence interval, or effect estimate is listed. In general, statistical significance and clinical importance are distinct: a test addresses compatibility with a statistical null under its assumptions, while clinical importance requires interpretation in context. Neither can be assessed for attendance without a posted estimate and analysis details.

The registry also includes general assumptions for a sample-size planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of an observed effect. Such assumptions describe a planning illustration, not the trial’s own design or observed power. They do not match the registered single-group model as a description of the study’s allocation. Because an observed effect and corresponding planning results are not reported in the record, this information cannot establish a study-specific sample-size justification or the precision achieved.

For a continuous outcome, a sample-size calculation generally depends on the target effect, variability, significance level, desired power, and design. These are planning inputs, not findings from participants. A planning illustration cannot replace an observed estimate, and it cannot show that a study had a particular probability of detecting an effect after results are known. No trial-specific sample-size justification is reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("AD Patients", "Caregivers")
n   <- c(14, 14)
m   <- c(85.12, 86.31)
sp  <- c(15.75, 15.19)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  AD Patients  14  85.120  15.750  76.026  94.214
CARM  Caregivers  14  86.310  15.190  77.540  95.080

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but it identifies only attendance in the record details available for interpretation. The other outcome’s name, definition, timing, and analysis are not reported in the registry record. It also lists zero analyses. The record therefore does not establish which measures were analyzed, which results were designated primary in the analysis, or how outcome results were selected for reporting.

Multiplicity is the issue that arises when multiple outcomes, comparisons, or statistical tests are considered. In general, testing more hypotheses can increase the chance of a false-positive finding if the analysis does not account for the number of tests. No multiplicity strategy, such as a hierarchy of outcomes or an adjustment procedure, is reported in the registry record. Because no test results are posted, there is no multiplicity-adjusted or unadjusted result to interpret.

Missing data handling is also not reported in the registry record. The record does not state how many participants completed the intervention, whether attendance records were incomplete, how missing observations were treated, or whether any imputation was used. These details matter because an analysis based only on participants with observed attendance may differ from an analysis that handles missing values using a stated model or assumptions.

The analysis population is not reported in the registry record. It is not clear which participants contributed to each outcome or whether caregivers and patients were analyzed separately, together, or in another way. The presence of separate AD Patients and Caregivers safety groups does not establish the analysis population for attendance. Without a prespecified analysis description and posted results, the extent of selective reporting, missing-data influence, or multiplicity cannot be determined.

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.

The registry lists AD Patients and Caregivers separately. For each group, 15 people are listed as at risk. The record reports zero serious adverse events, zero other adverse events, and zero deaths in each group. These are counts in the registry record, not estimates of comparative safety.

A zero count means that no event in that category is recorded for the listed group in the posted data. It does not prove that the intervention is free of risk or that no event occurred outside the recorded categories or observation process. The record does not report the safety surveillance period, the method for collecting events, or whether every participant was monitored for the same duration.

The safety groups do not create a treatment-control comparison. No comparator is described, and the study model is single-group. The counts should therefore be read descriptively, without calculating or implying a between-group safety difference. The posted information supports only the statement that the registry reports no serious adverse events, other adverse events, or deaths for either listed group.

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

The record documents a completed feasibility study of at-home telehealth yoga for people with Alzheimer disease and chronic pain and their caregivers. It identifies attendance during 12 weeks as the primary outcome and provides a definition for that measure. This establishes what the study intended to assess as its primary endpoint, but the registry does not provide the numerical attendance result.

Without the observed result, its variability, or a confidence interval, the degree of participation and the precision of any estimate cannot be evaluated. The registry also does not report an analysis of pain change. Attendance should not be treated as a proxy for improvement in pain, and the study’s stated purpose does not substitute for a posted clinical outcome.

The single-group design is descriptive rather than a randomized comparison. The record does not identify a control group or a comparative treatment estimate. Consequently, the posted information cannot establish that any observed change was caused by yoga. In this case, the registry does not report such a change in the first place.

The safety record lists zero serious adverse events, zero other adverse events, and zero deaths among 15 at risk in each of the AD Patients and Caregivers groups. Those counts are limited to what is recorded and do not prove that an intervention has no risks.

In short, the registry conveys the feasibility question, intervention format, design classification, enrollment, and endpoint definition. It does not supply the outcome results needed to determine how well attendance was achieved or whether pain changed. No treatment recommendation or claim of benefit or lack of benefit follows from the information recorded.

14. Why This Trial Matters Statistically

Feasibility studies address practical questions that can arise before a larger evaluation: can an intervention be delivered in the intended setting, and do participants take part? This study is notable for examining at-home video-based yoga with people living with Alzheimer disease and chronic pain alongside caregivers. The registry identifies attendance as the primary measure, which directly concerns participation in the proposed delivery format.

From a statistical perspective, clearly distinguishing feasibility outcomes from clinical outcomes is important. Attendance can characterize engagement, while a pain measure would address a different question. The registry describes the study as evaluating yoga for chronic pain, but its named primary endpoint is attendance. The distinction prevents an implementation measure from being interpreted as evidence of a clinical effect.

The record also illustrates why design labels and outcome results need to be read together. A completed status, enrollment of 30, and separate safety-group counts do not provide an estimated attendance value or a controlled comparison. The single-group designation means that the record does not describe a randomized control contrast. Without posted outcome analyses, even the feasibility endpoint cannot be quantitatively characterized.

For researchers planning similar work, the record points to the importance of reporting how attendance is defined and collected, how missing observations are handled, and which analysis population contributes to each result. Those details are not reported in this record. The study’s subject and delivery setting make feasibility a relevant statistical target, but the posted registry information does not permit a conclusion about the level of feasibility achieved.

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 main limitation for interpretation is the absence of posted outcome estimates. Although attendance is defined as the percentage of classes attended during 12 weeks, no mean, standard deviation, or other result is reported in the registry record. The record lists two outcome measures, but the second outcome is not described in the information available. No analyses are listed, so statistical methods and estimates cannot be assessed.

The design is recorded as single-group, with allocation listed as NA and no masking. A control comparison is not described, limiting any causal contrast. The registry does not report participant flow, completion, attendance denominators, or the handling of missing values. It also does not give the analysis population or explain whether patient and caregiver outcomes were analyzed separately.

The arm description is incomplete: it includes a passage referring to five outpatient adults with mild Alzheimer disease and chronic musculoskeletal pain and their caregivers, then cuts off while describing later delivery. The relationship of that passage to the enrollment of 30 and the final intervention delivery is not reported in the registry record. The record also does not specify the number of classes offered, session duration, adherence criteria, or reasons for missed classes.

The reported safety counts lack a stated observation window and collection procedure. Zero recorded events cannot establish the absence of events or risks. Finally, the listed planning assumptions describe equal allocation between two arms, whereas the registered model is single-group; the record does not report a trial-specific sample-size justification that resolves this distinction.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's — NCT04512040.
• Registry record last updated 2023-06-15; status last verified 2023-06.
• Results first posted 2023-06-15.
• 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

NCT04512040 is a completed feasibility study titled “At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's.” The official title is “Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain.” The sponsor is Palo Alto Veterans Institute for Research. The registry lists a start date of 2021-02-25, a primary completion date of 2022-05-09, and enrollment of 30.

The intervention is behavioral at-home yoga delivered by tablet-based video conferencing. The study is registered as single-group, with allocation listed as NA and masking as none. The primary measure is the percentage of classes attended during 12 weeks. The registry lists two outcome measures and zero analyses, but does not report the primary attendance result or the details of the other outcome.

For AD Patients and Caregivers, the record lists 15 at risk in each group, with zero serious adverse events, zero other adverse events, and zero deaths in each. The registry record does not report a control comparison, a statistical analysis, or a numerical treatment-effect estimate.