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 Phone-Based Based Walk With Ease Program for Adults With Arthritis (NCT05289544), a randomized na study. The primary outcome is Change in Pain.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05289544 |
| Phase | NA |
| Condition | Arthritis, Gout, Fibromyalgia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 267 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of South Carolina |
| Results posted | Yes |
2. Clinical Question
Population
Adults with arthritis are the population named in the trial title. The registry also lists arthritis, gout, fibromyalgia, rheumatoid arthritis, osteoarthritis and systemic lupus erythematosus among the conditions. More detailed eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
A telephone-based version of the Arthritis Foundation’s Walk With Ease program, adapted for phone delivery. The registry describes the intervention as behavioral.
Comparator
A delayed phone-based Walk With Ease program. Its start is scheduled after the 1 year assessment, so the groups differ in the timing of program access during the primary endpoint period.
Primary question
What mean change in pain score is recorded from baseline to 6 weeks in each randomized group? The posted result gives separate group estimates; a direct between-group effect estimate is not reported in the registry record.
The study objective includes short-term assessment at 6 weeks and 6 months, as well as a longer-term assessment at 1 year. The primary endpoint described in the record is narrower: change in pain over the baseline-to-6-week interval. This distinction matters when interpreting the posted result. It addresses the primary pain measure at the stated early follow-up, not every outcome or follow-up period named in the study objective.
The registry reports 267 participants enrolled. It does not provide enough information in the listed result to characterize who contributed data to the primary endpoint, how representative they were of adults with the listed conditions, or whether the randomized groups were similar on baseline characteristics. Those details are not reported in the registry record.
3. Trial Design
This is a randomized, parallel-group behavioral study of a phone-based Walk With Ease program. The registry lists single masking, but does not identify who was masked; that detail is not reported in the registry record. The sponsor is the University of South Carolina. The record gives the study start as 2022-04-01, primary completion as 2024-09-10, and status as completed.
The intervention group is described as receiving a telephone-based Walk With Ease program adapted from the Arthritis Foundation program. The comparator is a delayed version, which starts after the 1 year assessment. This design makes the timing of access central to the comparison. At the primary endpoint, the relevant contrast would ordinarily be between assignment to the phone-based program and assignment to delayed access, but the registry record does not post a direct estimate of that contrast.
The registered enrollment is 267. The primary result lists 132 participants for the phone-based program and 135 for delayed access. These are the group counts associated with the posted primary endpoint; the record does not explain whether they represent everyone randomized, everyone measured, or a specific analysis population.
The study objective names assessment at 6 weeks, 6 months and 1 year. The primary endpoint is change in pain from baseline to 6 weeks. The record lists 21 outcome measures and reports 12 secondary outcomes, including changes in physical limitations, physical activity and arthritis-management self-efficacy. The analytic plan, allocation concealment procedures, and details of implementation or adherence 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
| Stage | Phone Based Walk With Ease | Delayed Phone Based Walk With Ease |
|---|---|---|
| STARTED | 132 | 135 |
| COMPLETED | 109 | 115 |
| NOT COMPLETED | 23 | 20 |
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 | Phone-Based Walk With Ease Program | Delayed Phone-Based Walk With Ease Program | Total |
|---|---|---|---|---|
| Participants analysed | 132 | 135 | 267 | |
| Age, Continuous | years | 64.06 (SD 9.38) | 64.13 (SD 9.36) | 64.1 (SD 9.4) |
| Sex: Female, Male: Female | Participants | 122 | 123 | 245 |
| Sex: Female, Male: Male | Participants | 10 | 12 | 22 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 80 | 80 | 160 |
| Race (NIH/OMB): White | Participants | 46 | 52 | 98 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 2 | 5 |
| Actigraph Measured moderate-vigorous intensity physical activity | minutes/week | 51.32 (SD 10.36) | 54.83 (SD 11.24) | 53.08 (SD 10.8) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Pain, measured over Baseline to 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in pain from baseline to 6 weeks, summarized as a mean on a visual analog scale. The scale is described as ranging from 0 mm for no or low pain to 100 mm for high pain. The registry reports the mean change and a 95% confidence interval separately for each randomized group.
A change score expresses how the measure differs from the participant’s baseline score over the specified interval. Given the scale direction, a negative change corresponds to a lower pain score at follow-up than at baseline. That describes the direction of the measure; it does not by itself establish that the program caused the change. Changes in both groups can reflect many factors, and the primary question in a randomized comparison is usually addressed by comparing changes between groups.
Pain is a patient-reported experience, and a numeric scale offers a consistent way to record its level and change. A mean summarizes the group’s average change, but it does not show the range of individual experiences or how many participants improved, stayed the same or worsened. The registry record does not report a threshold for a clinically important change, nor a direct between-group estimate for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the phone-based program group, the reported mean change in pain from baseline to 6 weeks is -4.0, with a 95% confidence interval from -11.3 to 3.3. For the delayed-program group, the mean change is -4.49, with a 95% confidence interval from -11.59 to 2.6. The estimates are group-specific mean changes, not an estimate of the difference between randomized groups.
Both mean changes are negative, corresponding to lower pain scores at follow-up on the scale described in the record. Each confidence interval includes values on both sides of zero. This indicates that the interval estimates are compatible with a range of mean changes, including a change in either direction. The intervals are not a direct test of whether the randomized groups differ, and their individual limits should not be treated as a substitute for a between-group confidence interval or test.
The two posted mean changes are close in magnitude, but a quantitative contrast should not be inferred by subtracting one group estimate from the other. The registry does not report a direct comparison, its confidence interval, or a p-value for the primary endpoint. The record also does not provide an adjusted analysis. Accordingly, the posted values describe what was recorded in each group, while leaving the comparative effect and its precision unreported.
Confidence intervals convey uncertainty around estimates under the statistical approach used to construct them. They do not display participant-level variation, establish the likelihood that a particular effect is true, or account automatically for bias from missing observations. The methods used to calculate these intervals and handle missing data are not reported in the registry record.
The study objective includes later follow-up at 6 months and 1 year, but the primary result is for baseline to 6 weeks. The posted values therefore should not be treated as a summary of the full follow-up period or as results for the secondary outcomes. The registry lists secondary outcome categories, but their estimates and methods are not reported in the registry record.
9. Statistical Methods Explained
The primary measure is continuous: pain is recorded on a numeric scale, and the result is summarized using a mean change. The two group means describe the average baseline-to-6-week change within each randomized group. The registry reports a 95% confidence interval alongside each mean. The record does not identify the exact statistical procedure used to calculate these intervals.
What does a confidence interval convey?
General statistical explanation: A confidence interval expresses the precision of an estimate under the model and procedure used to construct it. A narrower interval indicates greater precision than a wider interval, while an interval spanning a range of plausible values signals uncertainty about the exact underlying mean. It is not a range that contains every individual participant’s change, and it does not indicate how much participants’ outcomes varied around the mean.
For the phone-based group, the interval extends from -11.3 to 3.3 around a mean change of -4.0. For delayed access, it extends from -11.59 to 2.6 around a mean change of -4.49. The scale’s direction helps interpret these signs: lower scores indicate less pain on the stated scale. Because the intervals include zero, the group-specific estimates do not rule out no mean change under the interval procedure. This observation alone does not answer whether the groups differ.
Why is a direct group comparison important?
General statistical explanation: In a randomized trial, the treatment effect is usually expressed as a contrast between assigned groups. For a continuous endpoint, that contrast might be a difference in mean change, potentially with an interval reflecting uncertainty. Separate within-group estimates answer a different question: how much did the mean score change in each group? It is not valid to decide whether the group contrast is statistically distinguishable from zero simply by inspecting whether the separate confidence intervals overlap or include zero.
The registry record does not report a direct primary-outcome contrast, its confidence interval, or a p-value. It also does not state whether the means were adjusted for baseline values or other covariates. No unadjusted re-calculation is reported in the available record. As a result, the arm-level summaries cannot be used to recover the trial’s intended comparative estimate or its uncertainty without additional information.
What can be inferred from the randomized design?
General statistical explanation: Random assignment is intended to make groups comparable in expectation, so a properly conducted comparison can support a causal interpretation of assignment. That interpretation also depends on how participants were analyzed, follow-up completeness, adherence, outcome measurement and other design features. Randomization alone does not show that these conditions were met. Details about allocation procedures, the identity of the masked party, adherence, and the analysis population are not reported in the registry record.
The record identifies a parallel-group design and a delayed-start comparator. This means the registered comparison concerns assigned groups over a period when the delayed group has not yet begun the program. The record does not give the timing or results of analyses at the later assessment points, so the early endpoint should not be extended to those follow-ups.
How should planning illustrations be read?
General statistical explanation: Sample-size calculations estimate how many participants per arm a future study might require under stated assumptions. They are planning exercises, not estimates of what happened in the completed trial and not observed power. The registry’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation, a normal approximation, and a target effect described as a fraction of the observed effect. The record states that continuous-outcome illustrations are expressed as participants per arm; time-to-event illustrations, when applicable, use total events.
These assumptions do not establish that the original trial used the same design criteria. The original sample-size justification and statistical plan are not reported in the registry record. The observed group summaries alone do not establish a valid effect for planning without a defined contrast and its uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures and 12 secondary outcomes. The secondary outcome categories include changes in physical limitations, physical activity and arthritis-management self-efficacy. A study with multiple outcomes or follow-up assessments raises a multiplicity question: examining many results can increase the chance of at least one apparently notable finding by chance. Whether and how this was addressed is not reported in the registry record.
The record does not report a prespecified hierarchy among secondary outcomes, a multiplicity adjustment, or an analysis plan specifying which outcomes were confirmatory. It also records zero analyses in the analysis listing. The posted primary endpoint summaries are arm-specific means and confidence intervals; no direct group comparison is recorded for the primary endpoint. Estimates for the secondary outcomes are not reported in the registry record.
Missing-data handling is also not reported in the registry record. The primary result gives group counts, but does not explain whether these counts refer to randomized participants, participants with observed pain measures, or another analysis population. There is no reported description of missing endpoint values, reasons for loss to follow-up, imputation, sensitivity analyses, or how participants who did not follow the assigned program were handled.
These omissions limit interpretation because a mean based on observed outcomes can be affected if outcome availability is related to pain or group assignment. Without the analysis population and missing-data approach, the extent and direction of any such concern cannot be assessed from the registry record. The record also does not state whether the primary analysis followed randomized assignment regardless of program participation.
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 |
|---|---|---|---|
| Phone-Based Walk With Ease Program | 3 | 132 | 2.3% |
| Delayed Phone-Based Walk With Ease Program | 0 | 135 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Phone-Based Walk With Ease Program | 0 of 132 |
| Delayed Phone-Based Walk With Ease Program | 0 of 135 |
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 |
|---|---|
| Phone-Based Walk With Ease Program | 37 of 132 |
| Delayed Phone-Based Walk With Ease Program | 28 of 135 |
Most frequent serious adverse event terms
| Event term | Organ system | Phone-Based Walk With Ease Program | Delayed Phone-Based Walk With Ease Program |
|---|---|---|---|
| stroke | Vascular disorders | 1 of 132 | 0 of 135 |
| Aortic stenosis | Cardiac disorders | 1 of 132 | 0 of 135 |
| Brain surgery to remove tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 132 | 0 of 135 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Phone-Based Walk With Ease Program | Delayed Phone-Based Walk With Ease Program |
|---|---|---|---|
| Knee injury/swelling | Musculoskeletal and connective tissue disorders | 6 of 132 | 5 of 135 |
| Fall | Musculoskeletal and connective tissue disorders | 6 of 132 | 4 of 135 |
| Foot or ankle injury | Musculoskeletal and connective tissue disorders | 3 of 132 | 7 of 135 |
| Back injury/issue | Musculoskeletal and connective tissue disorders | 7 of 132 | 2 of 135 |
| Knee replacement | Musculoskeletal and connective tissue disorders | 3 of 132 | 3 of 135 |
| car accident | Injury, poisoning and procedural complications | 4 of 132 | 0 of 135 |
| Shoulder injury or surgery | Musculoskeletal and connective tissue disorders | 2 of 132 | 1 of 135 |
| Hip injury or surgery | Musculoskeletal and connective tissue disorders | 3 of 132 | 0 of 135 |
| Heart condition or procedure | Cardiac disorders | 1 of 132 | 2 of 135 |
| Gastrointestinal related diagnosis | Gastrointestinal disorders | 1 of 132 | 2 of 135 |
Serious events with the highest arm-level rate: stroke (0.8%), aortic stenosis (0.8%), brain surgery to remove tumor (0.8%).
The registry reports serious adverse events for each group. For the phone-based Walk With Ease Program, it records 3 affected participants among 132 at risk; for the delayed phone-based program, it records 0 among 135 at risk. Deaths are recorded as 0 in both groups. These are descriptive counts in the registry record and do not by themselves establish whether an event was caused by the program.
Other adverse events are recorded for 37 among 132 at risk in the phone-based group and 28 among 135 at risk in the delayed group. The record lists stroke, aortic stenosis and brain surgery to remove tumor among the top serious-event terms, each reported as 0.8%. The record does not provide further context about event timing, severity criteria, relatedness assessments, or whether terms refer to unique participants or events.
Serious and other adverse-event counts should be read separately. The counts do not establish comparative risk without a prespecified analysis and information about follow-up and ascertainment. The registry does not report a statistical comparison of adverse events. These figures are a record of reported events, not a basis for medical advice.
12. What the Result Does, and Does Not, Mean
The posted primary result describes mean pain-score change from baseline to 6 weeks in each randomized group. Both reported group means are negative, and both confidence intervals include zero. The registry does not provide the direct between-group estimate needed to quantify how assignment to the phone-based program compares with assignment to delayed access, or how precisely that contrast is estimated.
These findings should not be read as proof that the program works or does not work. A within-group change is not the same as a randomized treatment effect. Participants in both groups may experience changes over time, and the separate means do not isolate the contribution of program assignment. The record also does not provide a clinical-importance threshold for interpreting the scale change.
The result concerns the specified pain measure and the baseline-to-6-week timeframe. The study objective includes assessments at 6 months and 1 year, but those results are not described by the primary figures. Nor do the pain estimates summarize the listed secondary outcomes, such as physical limitations, physical activity or arthritis-management self-efficacy.
The confidence intervals communicate uncertainty about each group mean under the procedure used to calculate them, but that procedure is not reported. The registry record also does not report the analysis population, missing-data approach, adherence, or a direct comparison. These gaps mean the posted summaries offer a limited view of the trial’s evidence. They do not support a complete assessment of comparative effectiveness, clinical importance, durability, or the balance of benefits and harms.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it evaluates a behavioral intervention delivered by telephone and uses a delayed-start comparator. That setup makes the timing of access relevant: at the primary assessment, the groups represent immediate program access and delayed program access. A randomized comparison can be informative, but its interpretation depends on a direct analysis of the outcome between assigned groups.
The primary outcome is a continuous pain score summarized as mean change. This presentation is straightforward, but arm-specific means are not the same as the randomized contrast. The record’s lack of a direct between-group estimate is therefore important: readers can see the direction and uncertainty of each group’s mean change, but cannot determine the estimated difference attributable to assignment from the posted primary result.
The record also names multiple outcomes and follow-up periods. This creates statistical questions about which results were primary, how analyses across outcomes were handled, and how missing observations affected each result. The registry identifies the primary endpoint, but does not report the broader statistical plan or multiplicity approach. Those omissions make it difficult to distinguish confirmatory results from exploratory ones.
Finally, reporting group counts and adverse-event counts does not substitute for documenting analysis populations, follow-up completeness, or event definitions. These issues matter when assessing precision and potential bias. The trial record therefore illustrates why statistical interpretation relies not only on outcome values, but also on a clearly reported comparison, analysis methods and data completeness.
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 principal limitation of the posted primary result is that it reports separate group means rather than a direct comparison between randomized groups. No between-group estimate, confidence interval for that contrast, or p-value is reported in the registry record. Without that information, the comparative effect and its precision cannot be described from the posted result.
The record does not identify the statistical method used for the confidence intervals, whether the analysis adjusted for baseline pain or other factors, or which participants were included in the analysis. Although group counts accompany the result, their relation to the randomized population is not explained. Missing-data procedures, follow-up completeness, adherence and handling of departures from assigned treatment are not reported in the registry record.
The endpoint is limited to mean pain change from baseline to 6 weeks. The study objective also names 6-month and 1-year assessments, but their results are not reported in the primary result described. The registry lists secondary outcomes, but estimates for those outcomes are not reported in the registry record. The record also does not state a threshold for interpreting the clinical importance of a change in the pain scale.
Additional design information is limited. The record identifies single masking but not who was masked, and does not report allocation concealment or a detailed statistical plan. Serious and other adverse-event counts are available, but event definitions, timing and relatedness are not described. These limitations constrain interpretation; they do not establish that the trial was conducted improperly.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phone-Based Based Walk With Ease Program for Adults With Arthritis — NCT05289544.
- Registry record last updated 2026-03-06; status last verified 2026-02.
- Results first posted 2026-03-06.
- 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
NCT05289544 is a completed randomized, parallel-group study sponsored by the University of South Carolina. It evaluates a phone-based Walk With Ease program against a delayed phone-based program among adults with arthritis. The registry lists enrollment of 267 and describes the intervention as behavioral.
The primary endpoint is mean change in pain from baseline to 6 weeks on a visual analog scale, with 0 mm indicating no or low pain and 100 mm indicating high pain. The registry reports group-specific means and 95% confidence intervals: -4.0 with an interval from -11.3 to 3.3 for the phone-based program, and -4.49 with an interval from -11.59 to 2.6 for delayed access. A direct comparison is not reported in the registry record.
The objective includes follow-up at 6 weeks, 6 months and 1 year. The record lists secondary outcomes and adverse-event counts, but does not report the statistical analysis plan, missing-data methods, or analysis populations.