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 Flexibility and Strength Training in Asthma (NCT02370004), a na na study. The primary outcome is Forced Expiratory Volume at One Second - FEV1 % Predicted.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02370004 |
| Phase | NA |
| Condition | Asthma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Brigham and Women's Hospital |
| Results posted | Yes |
2. Clinical Question
Population
People with asthma were the intended study population. The registry record lists an enrollment of 11. It does not provide further eligibility details in the record, so characteristics such as asthma severity, age range, and prior treatment cannot be established from this information.
Intervention
Participants underwent Resistive Flexibility and Strength Training (RFST) with a trained practitioner. The registry describes the study as a proof-of-concept and feasibility effort, with a future goal of testing RFST in a larger randomized trial. Details of the training schedule and its delivery are not reported in the registry record.
Comparator
There was no concurrent control group. The record classifies the study model as single group and allocation as NA. Although the longer-term research aim mentions comparison with conventional physical therapy, that comparison was not part of this study. Any change over time therefore cannot be separated from other explanations using a randomized between-group contrast.
Primary question
The primary endpoint was change from baseline to end of study—5 weeks—in mean Forced Expiratory Volume at One Second (FEV1) % predicted. It measures pulmonary function. The registry record does not report the numerical change or its confidence interval, so it is not possible to determine the observed direction, magnitude, or precision of that endpoint from the record.
3. Trial Design
FASTA is the registry name for a study titled “Flexibility and Strength Training in Asthma.” The record lists Brigham and Women's Hospital as sponsor, asthma as the condition, and the study status as completed. The recorded start is 2014-07 and primary completion is 2015-04. Enrollment is listed as 11.
The design is single group, with allocation recorded as NA and masking recorded as none. The intervention was Resistive Flexibility and Strength Training, delivered with a trained practitioner. There was no control arm in this trial. In particular, the conventional physical therapy comparator described as a goal for future research should not be mistaken for a treatment group in this study.
The stated purpose was proof of concept and establishing feasibility of conducting a study of RFST in patients with asthma. The longer-term aim was to design a larger randomized trial to test a hypothesis about symptoms, pulmonary function tests, range of motion, and connective tissue mobility. This distinction matters: feasibility work can inform whether and how a later study might be organized, but a single-group study does not estimate a randomized treatment contrast.
The primary measure was mean FEV1 % predicted, with change from baseline to the end of study—5 weeks—as the stated timeframe. Secondary outcomes listed in the registry include the Asthma Control Test (ACT) and range-of-motion measurements using circumference and degree of motion. The record lists 4 outcome measures and 1 analysis. It does not describe the details of that analysis or how the secondary outcomes were handled.
Phase is recorded as NA. Sample-size justification, an interim-analysis plan, and additional design details are not reported in the registry record. The record's design description and stated feasibility purpose should guide interpretation rather than assumptions about a larger or controlled trial.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Resistive Flexibility and Strength Training |
|---|---|
| STARTED | 11 |
| COMPLETED | 10 |
| NOT COMPLETED | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Resistive Flexibility and Strength Training |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 22.8 (19 to 29) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Forced Expiratory Volume at One Second - FEV1 % Predicted, measured over Change from baseline to end of study - 5 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | % predicted |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is “Forced Expiratory Volume at One Second - FEV1 % Predicted.” FEV1 measures the volume of air forcibly exhaled in the first second of a breathing test. Expressing it as a percentage of predicted value relates the measurement to a reference expectation. The registry describes it as an assessment of pulmonary function.
The endpoint is specified as a mean, and the target is change from baseline to end of study—5 weeks. A change-from-baseline measure asks whether the group’s average value differed at the later assessment from its starting value. Because this is a single-group study, such a change describes a before-and-after pattern; it is not, by itself, an estimate of what would have happened under a control intervention.
General statistical explanation: a continuous pulmonary-function measure can capture variation across participants rather than reducing results to a simple event/no-event outcome. A mean gives a group-level summary, although it does not show the range of individual responses. A confidence interval conveys uncertainty around an estimated quantity: a narrower interval indicates greater precision, while a wider interval indicates less precision.
The registry identifies a 95% confidence interval as the dispersion measure for this endpoint. However, the numerical mean change and interval are not reported in the registry record. Consequently, the result's direction, magnitude, and precision cannot be evaluated from the recorded information. The endpoint is identified, but its observed estimate is not available in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record establishes the study's question and structure, but not the numerical primary result. It identifies mean change in FEV1 % predicted from baseline to end of study—5 weeks—and specifies a 95% confidence interval. The actual estimate and interval are not reported in the registry record. Without them, there is no basis for describing whether the mean changed upward or downward, how large the change was, or how uncertain the estimate may be.
The trial is a single-group study of RFST in people with asthma. Its stated purpose was proof of concept and feasibility, with a future randomized comparison as a longer-term goal. This structure supports description of what was observed in the group over time, but it cannot isolate the effect of RFST from other causes of change. For example, in general, repeated measurement, changes in participants' circumstances, or natural fluctuation can contribute to a before-and-after difference. Those are general considerations, not findings reported for this trial.
The registry also lists ACT and range-of-motion outcomes. Their inclusion indicates that the study considered more than pulmonary function, but the record does not provide numerical results for them. It is therefore not possible to characterize their observed changes or compare their precision with the primary endpoint. The stated future hypothesis also mentions connective tissue mobility, but a hypothesis for a future trial is not evidence of an observed result in this trial.
The registry lists enrollment of 11. That context is important when considering how precisely a mean might be estimated, but the absence of the actual confidence interval prevents an assessment of precision. Enrollment alone does not establish what effect was observed, whether any result was statistically distinguishable from no change, or how broadly it might apply. No p-value for the primary outcome is reported in the registry record.
There was no concurrent randomized control group, and the record lists no masking. These features limit causal interpretation: a change between baseline and follow-up cannot be attributed uniquely to the intervention based on this design. The record does not report participant-level outcomes, adjustment procedures, or enough analysis detail to assess how those issues were addressed.
The registry reports zero serious adverse events and zero other adverse events in the intervention group among 11 at risk. These are the reported event counts, not a guarantee that every possible harm was assessed or that no unrecorded event occurred. Deaths are not numerically reported. Overall, the posted information supports a description of the study as completed feasibility work with a specified primary endpoint, but does not support a conclusion about the endpoint's observed effect.
9. Statistical Methods Explained
What does the primary measure summarize?
The registry defines the primary outcome as a continuous measure: mean FEV1 % predicted. A continuous variable can take values along a scale, and the mean summarizes the central level of a group’s measurements. The endpoint is framed as change from baseline to end of study—5 weeks. In a before-and-after analysis, the quantity of interest is the group-level change across those assessments, not a comparison between separate treatment arms.
The registry specifies a 95% confidence interval as the dispersion measure. General statistical explanation: a confidence interval describes uncertainty around an estimate under the assumptions of the analysis. It is not a display of every participant’s measurement, and it does not by itself resolve whether an observed change is clinically meaningful. Interpretation depends on the estimate, the interval, the measurement context, and the design. Here, neither the numerical mean change nor its interval is reported in the registry record.
What can a single-group design estimate?
The model is single group, with no concurrent control group. Such a design can describe measurements before and after an intervention, but it does not provide a randomized contrast against an alternative. General statistical explanation: a control group helps distinguish changes associated with the intervention from changes that might occur over time for other reasons. Random allocation, when used, helps make groups comparable on average at the outset. Neither a randomized comparison nor a control arm is reported for this study.
As a result, a before-and-after difference, even if its numerical value were available, would not alone establish that RFST caused it. This is a design limitation rather than a judgment about the size or direction of the unreported estimate. The registry’s stated goal of informing a future larger randomized trial is consistent with separating feasibility work from a later comparative test.
How should uncertainty be read?
General statistical explanation: estimates from a study are subject to sampling variability. A confidence interval communicates some of that uncertainty by giving a range of values compatible with the estimate under the chosen statistical procedure and assumptions. The interval's width is informative about precision; it is not a direct measure of bias, and it does not correct for limitations such as the lack of a control group.
The registry identifies the interval type but not its values. No numerical inference about precision can therefore be made. The enrollment of 11 is reported, but no result should be reconstructed from enrollment alone. The record also does not report a p-value for the primary outcome or specify a statistical model, assumptions, or adjustment strategy for the primary analysis.
What is over-dispersion, and is it relevant?
General statistical explanation: over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make uncertainty estimates too small if the model does not accommodate the extra variability. The term is often relevant to count outcomes, but the listed primary outcome is continuous. The registry record does not report a variance model or an over-dispersion assessment, and there is no basis to say that over-dispersion was present or tested in this analysis.
How does planning relate to observed results?
The registry includes sample-size assumptions for a planning illustration based on an observed effect: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not a description of the actual single-group design. The illustration does not turn the study into a two-arm trial, and the registry does not provide resulting planning counts in the registry record.
General statistical explanation: a planning calculation asks how much information a future study might need under specified assumptions. Such a calculation is different from observed power, which is not an appropriate substitute for examining an estimate and its uncertainty after results are available. The planning illustration is not evidence that the current study had a particular power, nor does it supply a missing primary result. A sample-size justification for the trial itself is not reported in the registry record.
What analysis details remain unknown?
The record lists 4 outcome measures and 1 analysis, but does not provide enough information to identify the analysis population, handling of missing measurements, precise statistical test, or treatment of repeated measures. It also does not report whether any covariates were included. These details matter because different analytic choices can affect estimates and uncertainty. They should not be inferred from the outcome title or the reported study design.
In general, an analysis plan should clarify the outcome definition, the population included, how missing data are handled, and the method used to calculate uncertainty. Those elements are not reported in the registry record. Accordingly, interpretation should remain limited to the registry's stated endpoint and design, without implying that an unreported method was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and secondary outcomes that include the Asthma Control Test (ACT) and range-of-motion measurements based on circumference and degree of motion. It also lists 4 outcome measures and 1 analysis. The record does not explain how many statistical comparisons were planned, whether all listed outcomes were analyzed, or whether any adjustment was made for examining multiple outcomes.
General statistical explanation: when several outcomes or comparisons are examined, the chance of finding an apparently unusual result by chance can increase. Multiplicity procedures can address that issue, but their use depends on the analysis plan and the questions being tested. No such procedure is reported in the registry record, so it is not appropriate to assume either that an adjustment was made or that it was needed in a particular way.
Missing-data methods are not reported in the registry record. The record does not state how many participants contributed measurements at each assessment, whether any follow-up measurements were unavailable, or how missing values were handled. Enrollment of 11 does not answer those questions.
The analysis population is also not reported in the registry record. The available information does not specify whether the analysis included all enrolled participants, only those with measurements at both time points, or another defined group. There is no reported interim-analysis plan or detailed statistical analysis plan. These omissions constrain assessment of bias and reproducibility; they do not establish that a particular problem occurred.
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 |
|---|---|---|---|
| Resistive Flexibility and Strength Training | 0 | 11 | 0.0% |
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 |
|---|---|
| Resistive Flexibility and Strength Training | 0 of 11 |
The registry reports the intervention group as having 11 participants at risk for serious adverse events and 0 affected. It also reports 11 at risk for other adverse events and 0 affected. These figures describe the event counts entered in the registry for the listed group. They do not provide detail about event definitions, surveillance procedures, duration of safety follow-up, or whether every possible event was captured; those details are not reported in the registry record.
Zero reported events should be read as a count, not as proof that the intervention has no risks. In general, a small study can provide limited information about uncommon events, and the absence of a recorded event does not establish the absence of risk. The record gives no comparative safety estimate because there was no concurrent control group.
Deaths are listed as null rather than as a numerical count. The number of deaths is therefore not reported in the registry record. The serious and other adverse-event entries should not be interpreted as a complete clinical safety assessment beyond what the registry reports.
12. What the Result Does, and Does Not, Mean
The study record documents a completed, single-group investigation of RFST in people with asthma, with a stated feasibility and proof-of-concept purpose. Its primary endpoint was mean FEV1 % predicted, measured as change from baseline to end of study—5 weeks. The design and intended future research aim are clear, but the numerical primary outcome is not reported in the registry record.
That missing estimate is decisive for interpreting the result. Without the mean change and its 95% confidence interval, the direction and size of the observed primary outcome cannot be described, and its precision cannot be assessed. It is also not possible to determine from the registry record whether the observed estimate would be considered statistically distinguishable from no change. No conclusion about the primary endpoint should be inferred from the study title, its completion status, or its enrollment.
Even if the before-and-after estimate were available, the single-group design would limit causal interpretation. The study does not include a randomized control comparison with conventional physical therapy. A measured change over time could reflect the intervention, other changes over time, or a combination; the design cannot separate these explanations as a controlled randomized comparison would.
The registry's stated aim was to establish feasibility and inform the design of a larger randomized trial. This is distinct from demonstrating a treatment effect. The record lists secondary outcomes, but their numerical results are not reported in the information. The listed safety counts are zero serious and zero other adverse events among 11 at risk, while deaths are not reported as a numerical count. Those entries do not establish absence of risk.
In statistical terms, the record supports understanding what the researchers set out to measure and the limits of the study structure. It does not support claims about the magnitude, reliability, or clinical importance of an observed change, because the endpoint estimate itself is not reported.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a feasibility study and a comparative efficacy study. FASTA was designed as proof-of-concept and feasibility work, with the longer-term aim of informing a larger randomized trial. Its single-group structure is suited to describing the study's approach and the measurements collected, but it cannot provide a randomized comparison with conventional physical therapy.
The record also makes clear why identifying an endpoint is not the same as reporting a result. FEV1 % predicted and the baseline-to-end-of-study timeframe are specified, as is a 95% confidence interval. Yet the estimate and interval are not reported in the registry record. Without those values, the reader cannot assess either the direction of change or how precisely it was estimated.
General statistical explanation: reporting an estimate together with an uncertainty interval helps readers judge the range of results compatible with the analysis. Design information remains equally important: precision does not remove confounding, and a narrow interval from a single-group study would not create a control comparison. Statistical interpretation depends on both the numerical evidence and how the data were generated.
The registry's longer-term goal is to test a hypothesis in a larger randomized study. Such a future study would address a different question from whether a single-group feasibility effort could be conducted. The record does not report a sample-size justification for this trial or enough analysis detail to reconstruct its primary result. Recognizing these boundaries helps prevent a feasibility record from being read as proof for or against a treatment effect.
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 central limitation for interpreting the outcome is that the numerical primary result is not reported in the registry record. The primary endpoint is identified as mean change in FEV1 % predicted with a 95% confidence interval, but neither the estimate nor the interval is available. The direction, magnitude, and precision of the change therefore cannot be assessed.
The design is single group, with no randomized comparator and masking listed as none. As a result, a before-and-after pattern cannot establish that any change was caused by RFST or distinguish it from other explanations. The conventional physical therapy comparison appears as a future research aim, not as a control group in this study.
Enrollment is listed as 11. The record does not report detailed participant characteristics or enough information to judge how broadly the findings might apply. It also does not describe the intervention schedule in detail. Missing-data handling, the analysis population, statistical model, and covariate adjustment are not reported in the registry record.
Although secondary outcomes are listed, their numerical results are not reported in the registry record. The record does not explain multiplicity handling or provide a detailed analysis plan. The sample-size justification for the trial itself is not reported; the planning assumptions described for a future two-arm illustration should not be treated as the study's own design or as observed power.
Safety reporting is limited to the recorded adverse-event counts. Serious and other adverse events are reported as 0 among 11 at risk in the intervention group, while deaths are not reported as a numerical count. Further safety follow-up details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Flexibility and Strength Training in Asthma — NCT02370004.
- Registry record last updated 2020-06-04; status last verified 2020-05.
- Results first posted 2020-06-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
FASTA (NCT02370004) is a completed single-group study of Resistive Flexibility and Strength Training in people with asthma. The registry lists Brigham and Women's Hospital as sponsor, enrollment of 11, and no masking. The recorded study start is 2014-07, with primary completion in 2015-04.
The primary endpoint was mean FEV1 % predicted, measured as change from baseline to end of study—5 weeks, with a 95% confidence interval specified. The registry record does not report the numerical endpoint result. Listed secondary outcomes include ACT and range-of-motion measurements. The study's stated purpose was proof of concept and feasibility, to inform a future larger randomized trial.
The record reports 0 serious and 0 other adverse events in the intervention group among 11 at risk. Deaths are not reported as a numerical count. The single-group design does not provide a controlled estimate of the effect of RFST.