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 Developing an Activity Pacing Framework: Feasibility and Acceptability (NCT03497585), a registered phase not stated study. The primary outcome is Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03497585 |
| Phase | Phase not stated |
| Condition | Chronic Pain, Fibromyalgia, Chronic Fatigue Syndrome |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 112 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pennine Acute Hospitals NHS Trust |
| Results posted | Yes |
2. Clinical Question
Population
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. The registry lists chronic pain, fibromyalgia, chronic fatigue syndrome and chronic low back pain as conditions of interest. A total of 112 participants were enrolled; 107 commenced the programme and provided baseline data.
Intervention
A behavioral activity pacing framework intended to standardise how healthcare professionals instruct activity pacing within rehabilitation programmes. The registry describes the programme as lasting 6 weeks.
Comparator
No like-for-like control comparison is described. Allocation is not stated, and the record identifies the study as not being a randomized comparison. The listed arm is the Activity Pacing Framework arm.
Primary question
How does the mean Activity Pacing Questionnaire score change from baseline, measured up to one week before the programme, to the end of the 6-week programme? The registry identifies this as a feasibility and acceptability study, but a numerical change estimate and its 95% confidence interval are not reported in the registry record.
3. Trial Design
This completed study is titled “Developing an Activity Pacing Framework: Feasibility and Acceptability.” Its official title identifies it as Stage III of work to develop an activity pacing framework for managing chronic pain or fatigue. The study was sponsored by Pennine Acute Hospitals NHS Trust. The registry lists a start date of 2018-05-21, a primary completion date of 2019-12-31, and an enrollment of 112.
The intervention was behavioral: adult patients attended rehabilitation programmes underpinned by the activity pacing framework. The record lists one arm, Activity Pacing Framework. Allocation is not stated, and the registry explicitly characterizes the study as not being a randomized comparison. There is therefore no like-for-like control group described from which to estimate a comparative treatment effect.
The primary outcome concerns change in APQ-28 scores from baseline to the end of the 6-week programme. The registry also lists activity pacing, pain and depression outcomes at specified time points, including activity pacing and pain at 3-month follow-up. The registered secondary outcomes include APQ-28, an 11-point Numerical Rating Scale of Pain, and the Patient Health Questionnaire-9. A total of 28 outcome measures are recorded, but the registry lists zero analyses.
Of the 107 participants who commenced the programme and provided baseline data, 65 completed data collection at the end of the 6-week rehabilitation programme. These counts describe the recorded baseline and end-of-programme populations; the reason that data were not available for all participants is not reported in the registry record. No comparator group, allocation procedure or detailed analysis plan is 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.
Before assignment: This was a single-arm feasibility study. All patients received the same treatment, that is, they all attended the same rehabilitation programme that was underpinned by the activity pacing framework. Excluded from the study were those patients who did not meet the inclusion/exclusion criteria.
Overall Study
| Stage | Activity Pacing Framework |
|---|---|
| STARTED | 112 |
| COMPLETED | 57 |
| NOT COMPLETED | 55 |
Analysis population for the primary outcome, as defined in the registry: Of the 107 participants who commenced the rehabilitation programme and provided baseline data (T1), 65 participants completed the data collection at the end of the 6-week rehabilitation programme. There were two missing answers for APQ-28 Activity adjustment.
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.
Population: All 107 participants were included in the baseline analyses. Some questions have fewer than 107 responses in instances of missing answers. For the question regarding participants' conditions, they were able to check more than one answer.
| Characteristic | Unit | Activity Pacing Framework |
|---|---|---|
| Participants analysed | 107 | |
| Age, Continuous | years | 55.25 (SD 12.83) |
| Sex: Female, Male: Female | Participants | 92 |
| Sex: Female, Male: Male | Participants | 15 |
| Race/Ethnicity, Customized: Ethnicity – White (British, Irish, Other) | Participants | 99 |
| Race/Ethnicity, Customized: Ethnicity – Black (Caribbean, African) | Participants | 1 |
| Race/Ethnicity, Customized: Ethnicity – Mixed (White/Black, White/Asian, other) | Participants | 3 |
| Race/Ethnicity, Customized: Ethnicity – Asian (Indian, Pakistani, Bangladeshi, other) | Participants | 3 |
| Race/Ethnicity, Customized: Ethnicity – Asian Eastern (Chinese, other) | Participants | 0 |
| Conditions: Low back pain | Participants | 79 |
| Conditions: Chronic widespread pain | Participants | 52 |
| Conditions: Fibromyalgia | Participants | 29 |
| Conditions: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) | Participants | 12 |
| Conditions: Other (e.g. osteoarthritis) | Participants | 21 |
| Number of conditions: 1 condition | Participants | 41 |
| Number of conditions: 2 conditions | Participants | 49 |
| Number of conditions: 3 conditions | Participants | 12 |
| Number of conditions: 4 conditions | Participants | 2 |
| Number of conditions: 5 conditions | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme, measured over Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme.
| 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 the Activity Pacing Questionnaire score from baseline to the end of the 6-week programme. Baseline was defined as pre-treatment, up to one week before the programme. The APQ was developed to assess different themes of activity pacing. Its earlier version, the APQ-26, contained 26 items and was initially validated among patients with chronic pain or fatigue. Factor analysis identified five themes: activity adjustment, activity consistency, activity planning, activity acceptance and activity progression.
For this study, two items were added to the APQ-26 to reflect aspects of pacing not included in that version. The resulting APQ-28 is described as reflecting the content of the activity pacing framework. Each of the five themes is calculated as a mean score on a 0–4 scale, with higher scores indicating more implementation of pacing strategies.
Assessing change from baseline to the end of the programme is intended to describe how reported pacing strategies vary over the programme period. The endpoint is a continuous measure, and the registry specifies a mean with a 95% confidence interval as its summary. However, the numerical change, confidence interval and theme-specific results are not reported in the registry record. Two APQ-28 Activity adjustment answers were missing, according to the endpoint description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a study of feasibility and acceptability, not a randomized comparison of the framework against a control intervention. Its primary question is whether APQ-28 activity pacing scores changed between baseline and the end of the 6-week programme. The record identifies the intended summary as a mean change with a 95% confidence interval, but it does not report the numerical estimate or the interval. Consequently, the direction, size and precision of the primary outcome cannot be described from the registry record.
There is a distinction between an outcome being named and an outcome result being reported. The APQ-28 endpoint is defined in detail, including the score range and the interpretation of higher values, but no actual baseline, end-of-programme or change values appear in the record. The registry lists 28 outcome measures and zero analyses. The recorded outcome definitions alone do not establish whether activity pacing changed, how large any change was, or how consistently change was observed across participants.
Participant counts provide context for the available data. The primary outcome description states that 107 participants commenced the programme and provided baseline data, while 65 completed data collection at the end of the programme. These counts indicate that end-of-programme data were available for fewer participants than baseline data. The reasons for missing end-of-programme data, and whether the analysis included any participants without complete measurements, are not reported in the registry record. No missing-data method is reported.
The study has no like-for-like control comparison, and allocation is not stated. A change observed over time in a single intervention arm would not, by itself, separate the effect of the framework from other explanations for change. The registry record does not report an adjusted or unadjusted estimate, a comparison between arms, or a statistical analysis of the primary endpoint. It therefore supports a description of the study question and measurement approach, but not a numerical conclusion about change or a comparative effect.
The record’s stated planning assumptions concern an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. The record does not list numerical planning outputs. Those assumptions do not describe observed power, and the equal-allocation illustration should not be mistaken for the design of the listed single-arm study. No sample-size justification for this study is reported in the registry record.
9. Statistical Methods Explained
The primary outcome is continuous: the APQ-28 theme scores are means on a 0–4 scale. For a continuous measure, a mean describes the central value of the observations being summarized. The registry specifies that the primary endpoint is change from baseline to the end of the 6-week programme and that the result is to be summarized with a 95% confidence interval. The actual mean change and interval are not reported in the registry record, so the precision of the endpoint estimate cannot be assessed from the registered results.
What does a confidence interval convey?
In general, a confidence interval expresses uncertainty around an estimated quantity. A narrower interval indicates greater statistical precision than a wider interval, while the interval’s location describes the range of values compatible with the data and the method used. It is not a guarantee that the true value lies within a particular interval. Because this record gives no numerical interval for the APQ-28 change, neither its width nor the values it covers can be interpreted.
What does a change score represent?
In general, a change score compares measurements made at different times for the same outcome. Its interpretation depends on how the difference is defined, which participants contribute data, and how incomplete observations are handled. Here the registry identifies baseline and end-of-programme measurements and calls the outcome change, but it does not report a numerical estimate, the exact calculation used, or the analysis population. No direction or magnitude of change can therefore be inferred.
Why does the study design matter?
The registry lists one intervention arm and says the study was not a randomized comparison; allocation is not stated. In general, a before-and-after description can show how measurements in participants vary over time, but without a comparable control group it cannot isolate the intervention’s contribution from other possible influences. This is a design limitation for causal interpretation, not a reason to reinterpret the endpoint as a comparative result. The registry record does not report a control-arm estimate or an adjusted comparison.
What does the planning illustration mean?
In general, a sample-size calculation estimates how many observations may be needed under specified assumptions to detect a chosen effect with a chosen statistical procedure. The registry’s stated illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are planning assumptions, not a report of the study’s observed statistical power. The record lists no numerical planning results, and it does not report a sample-size justification for the study itself. Its equal-allocation assumption does not change the recorded design, which lists one intervention arm without a like-for-like control comparison.
Why can over-dispersion matter?
In general, over-dispersion occurs when outcome variability is greater than a statistical model assumes. If it is ignored, standard errors and confidence intervals can be too small, making estimates appear more precise than warranted. The primary outcome is described as a continuous mean, and the registry does not report a model, a variance assumption, or an over-dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was tested, found or corrected.
What can be learned from the listed analyses?
The registry lists 28 outcome measures and zero analyses. This does not supply numerical estimates for the primary or secondary outcomes. The record names APQ-28 activity pacing assessments at baseline, the end of treatment and 3-month follow-up; pain assessments at those time points; and depression assessments at baseline and the end of treatment. The registry does not report outcome values, hypothesis tests, model specifications, standard errors, confidence intervals for secondary outcomes or an analysis population. The endpoint description specifies a mean and a 95% confidence interval for the primary measure, but the corresponding results are not reported.
Interpretation should consequently distinguish the measurement plan from the statistical evidence. The described scale and time points establish what the investigators intended to assess. They do not substitute for reported estimates or uncertainty intervals. General statistical concepts can clarify what such estimates would mean, but no effect size, significance result or precision claim can be recovered from the information in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures, including repeated assessments of activity pacing, pain and depression. Considering multiple outcomes and time points can raise a multiplicity issue: in general, the more statistical tests conducted, the greater the chance of at least one apparently notable result arising by chance if each test is interpreted separately. A prespecified hierarchy, adjustment procedure or other approach can clarify how multiple results are to be interpreted. Such an approach is not reported in the registry record. The record lists zero analyses, so it does not report a set of test results or a multiplicity adjustment.
Missing data are relevant to the primary endpoint. The endpoint description says 107 participants commenced the programme and provided baseline data, while 65 completed data collection at the end of the 6-week programme. It also identifies two missing answers for APQ-28 Activity adjustment. The registry does not report why end-of-programme data were unavailable for some participants, whether the missing answers affected scoring, or how missing observations were handled in any analysis. Imputation, complete-case analysis and other missing-data methods are not reported in the registry record.
The analysis population is also not fully specified. The record gives counts for enrollment, baseline participation and end-of-programme completion, but it does not state which population was used to calculate the primary outcome or whether any eligibility or adherence criteria were applied to the analysis. No interim analyses or detailed statistical analysis plan are reported in the registry record. These omissions limit assessment of how the planned outcomes, incomplete observations and multiple measures would affect the interpretation of results.
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 |
|---|---|---|---|
| Activity Pacing Framework | 0 | 107 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Activity Pacing Framework | 0 of 107 |
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 |
|---|---|
| Activity Pacing Framework | 0 of 107 |
The registry lists the Activity Pacing Framework group with 107 participants at risk for serious adverse events and 0 affected. It also lists 107 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse event terms are listed. These are the adverse-event figures recorded for this study; they do not provide detailed event descriptions or a numerical account of the duration or completeness of safety follow-up.
A count of zero recorded events should be read as a report about events in the registry record, not as proof that no adverse events could occur. The record does not describe the adverse-event collection process, event definitions beyond the serious and other categories, or whether all enrolled participants contributed safety data. It also does not report a comparison group, so these figures cannot be used to estimate a comparative safety difference. The figures are limited to the recorded counts and should not be interpreted as a general safety conclusion.
12. What the Result Does, and Does Not, Mean
The registry record establishes that an activity pacing framework was evaluated in rehabilitation programmes for adults with chronic pain or fatigue, with feasibility and acceptability as the study’s focus. It defines a primary measure of change in APQ-28 scores from baseline to the end of a 6-week programme. It also identifies the scale’s five themes and states that higher theme scores indicate more implementation of pacing strategies. These details clarify what the primary outcome was intended to measure.
The record does not report a numerical primary outcome estimate, baseline or end-of-programme mean, or 95% confidence interval. It therefore does not show the size, direction or precision of any APQ-28 change. The registry lists zero analyses, and it does not report numerical results for the secondary outcomes. An outcome name, measurement schedule or study objective is not evidence that a particular result was observed.
The study is not described as a randomized comparison, and no like-for-like control group is listed. Even if a before-and-after change estimate were reported, a single-arm change would not by itself establish that the framework caused the change. In this record, the absence of the estimate means that even the magnitude of within-participant change cannot be assessed. The listed enrollment and completion counts describe the data collection context, but they do not supply an effect estimate or explain missing follow-up data.
Accordingly, the record supports an account of the study design, outcome definition, participant counts and recorded adverse-event counts. It does not support a conclusion about effectiveness, a comparative effect, the statistical significance of a result, or the precision of an estimated change. Feasibility and acceptability outcomes themselves are not numerically reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because it asks a measurement and implementation question in a rehabilitation setting: whether activity pacing can be instructed using a framework and assessed with an instrument tailored to that framework. The APQ-28 was modified from the APQ-26 by adding two items, and its five theme scores are intended to capture different aspects of pacing. Defining the measure and its scoring helps readers understand what a future reported estimate would represent.
At the same time, the record illustrates why a clearly described endpoint is not the same as a reported result. It specifies a mean change and a 95% confidence interval for the primary outcome, yet gives no numerical estimate or interval. Without those quantities, the result’s direction, magnitude and precision remain unknown. The registry’s zero listed analyses reinforces the distinction between registered outcome measures and statistical findings.
The participant counts also matter for interpretation. The record describes 107 participants with baseline data and 65 who completed end-of-programme data collection. Such information is necessary context for evaluating the available endpoint data, but the registry does not explain missing follow-up or state how the analysis population was defined. A reader therefore cannot determine how incomplete measurements were reflected in any estimate.
Finally, a single listed intervention arm and no like-for-like control comparison limit what a change over time could establish. The planning illustration’s equal-allocation assumption is not a description of the recorded study design and is not observed power. Taken together, these points make transparent outcome reporting, explicit missing-data handling and design-appropriate interpretation especially important for understanding feasibility studies.
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 registry record leaves several trial-specific uncertainties. It identifies the study as a feasibility and acceptability study, but does not report numerical feasibility or acceptability results. The primary endpoint is defined, yet the actual APQ-28 change estimate and its 95% confidence interval are absent. The record lists 28 outcome measures but zero analyses, so outcome-specific statistical results cannot be assessed.
The primary outcome description reports 107 participants with baseline data and 65 with end-of-programme data. It does not state why data were unavailable for participants who did not complete collection, whether the observed participants differed from those without follow-up, or how missing data were handled. Two missing answers are noted for APQ-28 Activity adjustment, but their effect on scoring is not described. The analysis population is not reported in the registry record.
The record lists one intervention arm and explicitly says the study was not a randomized comparison; allocation is not stated. Without a like-for-like control group, the design cannot provide a controlled estimate of the framework’s effect. The registry does not describe the statistical model, endpoint calculation details, multiplicity approach, interim analyses or detailed analysis plan. These elements are not reported in the registry record and should not be assumed.
The secondary outcomes span several constructs and time points, but their numerical results are not recorded. The adverse-event entries list zero affected participants and zero deaths, but detailed ascertainment and follow-up information are not described. Finally, the stated sample-size assumptions are for planning illustrations, while no numerical planning outputs or study-specific sample-size justification are reported. These limitations constrain both statistical interpretation and assessment of how completely the registered questions were answered.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Developing an Activity Pacing Framework: Feasibility and Acceptability — NCT03497585.
- Registry record last updated 2020-12-17; status last verified 2020-11.
- Results first posted 2020-12-17.
- 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
NCT03497585 is a completed feasibility and acceptability study of an activity pacing framework in rehabilitation programmes for adults with chronic pain or fatigue. The record lists enrollment of 112 and one behavioral intervention arm. It describes the primary endpoint as change in APQ-28 theme scores from baseline to the end of the 6-week programme, with higher scores indicating more implementation of pacing strategies.
The primary outcome estimate and its 95% confidence interval are not reported in the registry record. The record lists 28 outcome measures and zero analyses. Of 107 participants with baseline data, 65 completed end-of-programme data collection; two APQ-28 Activity adjustment answers were missing. The listed adverse-event figures are 0 affected for serious events, 0 affected for other events and 0 deaths. No like-for-like control comparison is described, and allocation is not stated.