Yoga and Female Concussion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Yoga and Female Concussion (NCT07170488), a non-randomized na study. The primary outcome is Post Traumatic Growth.

2. Clinical Question

3. Trial Design

This completed study, NCT07170488, is titled “Yoga and Female Concussion,” with the official title “Post Traumatic Growth After Concussion in Women.” The sponsor is the University of Pittsburgh. The registry lists the phase as NA and the study as non-randomized, with no masking and a sequential model. Enrollment was 27. The study start date was 2023-11-10 and primary completion was 2024-04-24.

The two behavioral interventions were yoga and yoga for a wait-list control group. The yoga group received a six-week, light-intensity yoga and meditation curriculum developed for people living with traumatic brain injury. It was delivered online and synchronously. The wait-list group received the yoga intervention after data collection for the yoga group was completed. The record does not provide a detailed account of how participants were assigned to the groups, or whether the groups were comparable at baseline.

The non-randomized design matters for interpreting any comparison. Random allocation is one way to balance measured and unmeasured participant characteristics across groups; it was not used in this study. Differences between groups could therefore reflect pre-existing differences, timing, or other factors in addition to the intervention. The registry record does not report adjustment methods or other approaches used to address this possibility. No masking was used, so participants and study personnel were not masked to group assignment according to the record.

The primary outcome was post-traumatic growth, assessed at baseline, 1 week post-yoga (Week 7), 4 weeks post-yoga (Week 10), and Week 19, after the wait-list control group had completed its yoga sessions. The record lists Female Sexual Function Index-6 (FSFI-6), resilience, and flourishing as secondary outcomes. It does not provide the full outcome schedule or results for these measures.

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

Analysis population for the primary outcome, as defined in the registry: Response rate at week 19 was much lower than earlier timepoints, leading to a smaller size. We completed the analyses for those without missing data.

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 Post Traumatic Growth, measured over Baseline (at enrollment), 1 week post-yoga (Week 7) and 4 weeks post-yoga (Week 10), and Week 19 (after the wait-list control group had completed their yoga sessions).

The primary endpoint is post-traumatic growth, measured with the Post Traumatic Growth Inventory-Expanded (PTGI-X). The registry describes it as a score on a scale, with scores ranging from 0-125 and higher scores indicating greater post-traumatic growth. It also identifies scores of at least 75 as a cutoff for moderate to high post-traumatic growth, and scores below 75 as low post-traumatic growth.

The measure is intended to capture positive psychological changes that may follow struggle with a life-changing event. That focus differs from measuring only impairments associated with concussion. The study’s stated question is whether a pilot yoga intervention improves PTGI-X scores for women who have had concussions. The scheduled measurements cover baseline and later follow-up points, including a timepoint after the wait-list group had completed yoga.

Scores, changes over time, and group comparisons are not reported in the registry record. The cutoff provides a way to categorize scores as described in the record, but does not itself show how participants scored or whether scores changed. Nor does the registry explain whether the principal analysis treated the outcome as a continuous score, a category, or both. That analytical detail is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a non-randomized, unmasked, sequential study with 27 enrolled participants. It does not report a detailed statistical analysis plan. In particular, the statistical test or model for the primary outcome, any adjustment variables, the handling of repeated measures, and the approach to between-group comparisons are not reported in the registry record. The entry lists 0 analyses, so there are no posted inferential results to interpret.

What a non-randomized comparison can establish

General explanation: randomization aims to make comparison groups similar, on average, with respect to factors that could affect outcomes. In a non-randomized study, group membership may be associated with participant characteristics, preferences, timing, or other factors. If outcome scores differ between groups, the difference may reflect the intervention, these other factors, or a combination. Statistical adjustment can address measured characteristics when appropriate data and a prespecified method are available, but cannot automatically resolve unmeasured differences.

For this study, the yoga group and wait-list control group followed different intervention timing. The wait-list group received yoga after data collection for the yoga group. The study used no masking. These features are important context for any outcome comparison, but the registry record does not describe the group assignment process, baseline balance, or adjustment methods. The record therefore does not support attributing a possible difference to yoga alone.

Repeated measurements and outcome summaries

General explanation: when an outcome is measured repeatedly in the same participants, measurements from one person are related rather than independent. An analysis may account for this correlation, or it may compare selected timepoints using another specified approach. The analysis choice affects which question is answered, such as change from baseline, a difference at follow-up, or an overall pattern over time. The registry lists baseline, 1 week post-yoga (Week 7), 4 weeks post-yoga (Week 10), and Week 19, but the statistical method for these measurements is not reported.

The PTGI-X is recorded as a score ranging from 0-125, with higher scores indicating greater post-traumatic growth. The registry also gives a cutoff: scores of at least 75 are used for moderate to high post-traumatic growth, and scores below 75 are deemed low post-traumatic growth. A score can be analyzed as a numerical scale or categorized using a threshold; these approaches answer different questions and retain different information. The record does not state which approach was used for the primary analysis.

Precision and uncertainty

General explanation: an estimate describes the size and direction of an observed pattern, while a confidence interval conveys uncertainty around that estimate under the chosen analysis. A p-value, when reported, addresses how compatible the observed data are with a specified null model; it does not measure the size or practical importance of an effect. These statistics are useful only when the estimate, analysis, and data are sufficiently described. No primary outcome estimate, confidence interval, or p-value is reported in the registry record, so none can be interpreted for this study.

The sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that a particular effect was detected. The effect magnitude and resulting participant counts for the illustration are not reported in the registry record. Such planning illustrations are not observed power and should not be treated as an outcome of the completed study.

Dispersion and distribution

General explanation: a mean describes the center of a set of scores, while a measure of dispersion describes how spread out those scores are. Distributions can be skewed, clustered, or otherwise different from the assumptions of a chosen model. For count outcomes, over-dispersion means the variability is larger than a model assumes; accounting for it can affect uncertainty estimates. These are general statistical considerations, not reported analyses for this trial. The record does not provide the distribution of PTGI-X scores or state which dispersion summary or model was used.

Because no primary outcome results or analysis details are posted, readers cannot assess the estimate’s precision, whether model assumptions were checked, or whether the analysis matched the longitudinal design. The design and timing identify questions an analysis could address, but do not establish which analysis was performed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures and identifies post-traumatic growth as primary. It names Female Sexual Function Index-6 (FSFI-6), resilience, and flourishing as secondary outcomes. It does not report the full set of outcome definitions and timepoints, or how multiple outcomes and time comparisons were handled. A multiplicity adjustment, hierarchy of tests, or other strategy to limit false-positive findings is not reported in the registry record.

General explanation: when many outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. A prespecified primary outcome and analysis can help readers distinguish the main question from additional exploratory questions. The registry identifies a primary outcome, but does not provide a statistical analysis plan or results that would show how the outcome and timepoints were analyzed. No conclusion about multiplicity control can be drawn from the record.

For missing data, the record states that the Week 19 response rate was much lower than at earlier timepoints, leading to a smaller size, and that analyses were completed for participants without missing data. This is a complete-case approach as described in the record. The number of participants with missing measurements, reasons for nonresponse, and missingness patterns are not reported. The record also does not report imputation, sensitivity analyses, or methods to account for differences between participants with and without observed data.

These omissions matter especially for the later follow-up. If participants with missing Week 19 outcomes differ systematically from those with observed outcomes, the complete-case results could give a distorted picture of the enrolled group. The direction or magnitude of any such distortion cannot be determined from the registry record.

11. 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 0 serious adverse events and 0 other adverse events among 12 participants at risk in the Yoga Group. For the Wait List Control Group, it lists 0 serious adverse events and 0 other adverse events among 15 participants at risk. The registry also lists 0 deaths in each group. These are the posted event counts for the groups and categories recorded.

Zero recorded events should be read as a description of the registry entry, not as proof that an intervention has no risks. The counts do not describe how events were solicited, what follow-up period was used for safety monitoring, or how complete the reporting was. The record does not list serious adverse event terms, and it does not provide event narratives or additional safety analyses.

The group counts are descriptive. Because the study was non-randomized, a direct comparison of the groups’ safety counts would not be a randomized comparison. The registry information also does not establish that the groups had identical time at risk or exposure. The event figures should therefore be interpreted narrowly as the counts posted for the participants listed at risk, rather than as a comparative estimate of safety.

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

The registry record describes a pilot study designed to explore post-traumatic growth after a yoga and meditation program for women who have had concussions. It specifies the PTGI-X as the primary outcome, gives its score range and interpretive cutoff, and records several planned measurement times. It also identifies a wait-list group that received yoga after data collection for the yoga group.

However, no primary outcome scores or statistical estimates are reported. The record does not show whether scores rose, fell, or remained similar over time, and it does not provide a between-group estimate. It is therefore not possible to determine from the posted results whether the study observed a change, how large any change was, or how precisely it was estimated. The absence of a reported result is not evidence of no change.

Even if an outcome comparison were available, its interpretation would need to account for the non-randomized design, lack of masking, and lower response rate at Week 19. These features limit how confidently a group difference could be attributed to the intervention and how well later measurements might represent all enrolled participants. The registry record does not report adjustment methods or missing-data sensitivity analyses.

The study can still be understood as an investigation of a relevant measurement question: whether post-traumatic growth scores change over time in this population during a yoga program and in a later wait-list sequence. But the record does not establish a treatment effect, a causal explanation, or a clinically meaningful change. Those conclusions require reported outcome data and sufficiently described analyses.

13. Why This Trial Matters Statistically

This study is statistically notable for examining a positive psychological outcome after concussion rather than focusing only on deficits. Its primary measure, the PTGI-X, gives the investigation a defined score range and a stated threshold for low versus moderate to high post-traumatic growth. That makes the outcome construct and its intended interpretation visible in the registry record.

The design also raises questions central to clinical research interpretation. Participants were not randomized, the study was unmasked, and the wait-list group received the intervention later. Those features shape the strength of any group comparison: a difference could reflect factors other than intervention timing, and a within-group change alone cannot separate intervention effects from changes over time or other influences. Clear reporting of assignment, baseline characteristics, analysis choices, and uncertainty would be important for understanding such results.

The Week 19 response rate was much lower than at earlier timepoints, and the registry says analyses were completed for participants without missing data. This highlights why outcome completeness and missing-data methods are part of the statistical evidence, not merely administrative details. Readers need to know how many measurements were available and how conclusions might depend on who remained observed.

Finally, this record illustrates the difference between a registered research question and a reported result. It contains the study design and outcome schedule, but no primary outcome estimates or analyses. That distinction prevents a planned measurement from being mistaken for evidence of an observed effect and clarifies what further reporting would be needed for an informative statistical interpretation.

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 main limitation for interpreting the primary question is that the registry record does not report PTGI-X results. There are no posted scores at baseline or follow-up, no change estimates, no group comparison, and no measure of uncertainty. Although the study is marked completed, completion status alone does not supply an outcome finding.

The non-randomized allocation limits causal interpretation. The record does not explain how participants entered each group, give baseline characteristics, or report whether statistical adjustment was used. With no masking, expectations or awareness of group assignment could also affect self-reported outcomes; the record does not describe procedures intended to address this possibility.

Follow-up completeness is another concern. The Week 19 response rate was much lower than at earlier timepoints, and analyses were completed for participants without missing data. The number missing and reasons for missingness are not reported, nor are sensitivity analyses. This leaves uncertainty about how representative the later observed outcomes would be of the full enrolled group.

The record also does not report the detailed statistical analysis plan, including the model for repeated measurements, treatment of the PTGI-X cutoff, adjustment for multiple outcomes, or handling of potential group differences. Eight outcome measures are listed, but the complete outcome and analysis details are not available. Finally, the enrollment was 27; the record does not establish how broadly the findings, if reported, would generalize beyond the study participants. These limitations restrict conclusions about magnitude, precision, causality, and applicability.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Yoga and Female Concussion — NCT07170488.
• Registry record last updated 2025-12-10; status last verified 2025-11.
• Results first posted 2025-12-10.
• 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.

18. Record Summary

NCT07170488, “Yoga and Female Concussion,” is a completed, non-randomized, unmasked study sponsored by the University of Pittsburgh. The registry lists 27 participants and a sequential model. The yoga group received a six-week online yoga and meditation curriculum; the wait-list control group received yoga after data collection for the yoga group.

Post-traumatic growth measured by PTGI-X was the primary outcome, scheduled at baseline, Week 7, Week 10, and Week 19. Secondary outcomes included FSFI-6, resilience, and flourishing. The record notes a lower response rate at Week 19 and complete-case analyses, but does not report outcome values, estimates, or inferential analyses. It lists 0 serious and 0 other adverse events in each group and 0 deaths in each group.