Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home (NCT02828826), a randomized na study. The primary outcome is Score ̏ Timed Up and Go ( TUG ) at 6 Months of SSR Output.

2. Clinical Question

This is a comparison of assigned groups, not a comparison based on whether participants completed a particular number of calls. The registry record does not report call attendance or adherence, and the posted results do not give an analysis relating the number of calls received to performance. The trial therefore addresses the group-level contrast between assignment to coaching and assignment to no coaching as recorded in the results.

The question has practical and statistical dimensions. The intervention is a form of follow-up intended to support maintenance of exercise at home, while the primary measure is a timed physical performance test. The result describes the average observed test times among participants with posted outcome data. It does not by itself establish whether any difference is important to patients, or how the result might apply beyond the study participants. No threshold for a clinically important difference is reported in the registry record.

3. Trial Design

The registry record describes a randomized, parallel-group trial with no masking. Enrollment was 101, and the study status is terminated. The listed condition is fall. The sponsor is Nantes University Hospital. The record lists a start date of 2016-10-17 and a primary completion date of 2022-08-04.

Participants were assigned to telephone coaching or no telephone coaching. The coaching arm description states that a physiotherapist programmed 5 calls at times convenient for the patient. The record does not report a detailed account of the content or duration of the calls, the exact timing beyond the description, or the extent to which participants received the planned calls. Those details are not reported in the registry record.

The primary endpoint is the Timed Up and Go score at 6 months of SSR output. The posted group summaries include 37 participants in the telephone coaching group and 39 in the group without telephone coaching. The primary outcome description notes missing data for 23 patients. The record does not explain how missing outcomes were handled in the analysis, or whether the analysis population was defined by intention to treat or another approach.

The record includes 9 posted secondary outcomes, including a 12-month Timed Up and Go result and a Five Timed Sit to Stand Test result at 6 months. The registry record does not report analyses for these outcomes, and no further secondary outcome estimates are posted in the registry record described for this trial. The available numerical secondary results are therefore limited to the named measures with group summaries and comparisons.

The original sample-size rationale, planned analysis model, interim analysis arrangements, and any prespecified statistical analysis plan are not reported in the registry record. The study’s terminated status is recorded, but the reason for termination is not reported. These gaps limit how far the observed results can be checked against the original intended design.

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: Eligible according to inclusion and exclusion criteria

Overall Study

Analysis population for the primary outcome, as defined in the registry: Missing Data for 23 patients

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: Patients Randomized

6. Primary Endpoint

The registry lists the primary outcome as Score ̏ Timed Up and Go ( TUG ) at 6 Months of SSR Output, measured over 6 months.

The primary endpoint is the Timed Up and Go test score at 6 months, measured in seconds. In the test description, the participant rises from a standard chair, walks to a line marked 3m away, turns, returns, and sits. The examiner uses a stopwatch and does not encourage the participant. Participants perform the test once to check understanding and then complete a timed attempt.

The test is used as a measure of physical performance involving standing, walking, turning, and sitting. A shorter completion time corresponds to completing the test more quickly. The registry description states that the test takes place in a quiet room and that participants use their shoes and usual technical assistance. It also describes the test as having good reproducibility and reports diagnostic validity for fall prediction, though those statements are background information in the registry record rather than findings from this trial.

For the trial comparison, the endpoint is summarized as a group mean and standard deviation. This allows the posted results to describe the average time and the spread of participant times in each assigned group. A mean comparison does not reveal every participant’s performance or the distribution’s shape. Nor does the test result alone establish a meaningful difference to participants: the registry record does not report a threshold for clinical importance or a responder definition.

7. Results Posted in the Registry

• Without Telephone Coaching: mean 12.90 versus 14.80 on control; difference -1.90 (95% CI -4.49 to 0.69), standardized effect d = -0.33; z-test p = 0.151.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Score ̏ Timed Up and Go ( TUG ) at 12 Months of SSR Output

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Without Telephone Coaching: mean 12.20 versus 14.90 on control; difference -2.70 (95% CI -5.94 to 0.54), standardized effect d = -0.39; z-test p = 0.102.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Without Telephone Coaching and the control. The interval gives the range of effects that remain compatible with the data.

Score of FTSST (Five Timed Sit to Stand Test)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Without Telephone Coaching: mean 15.00 versus 15.30 on control; difference -0.30 (95% CI -2.57 to 1.97), standardized effect d = -0.06; z-test p = 0.796.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Without Telephone Coaching and the control. The interval gives the range of effects that remain compatible with the data.

The posted numerical secondary results cover two types of physical performance measure: Timed Up and Go at 12 months and the Five Timed Sit to Stand Test at 6 months. The comparisons are unadjusted and their confidence intervals cross zero. Their point estimates do not provide a consistent, precise pattern that clearly separates the assigned groups. These findings broadly resemble the primary result in leaving uncertainty about the direction and size of a group difference.

The 12-month Timed Up and Go result is related to the primary endpoint because it uses the same test at a later time point. It can describe whether the observed pattern at 6 months is also present in the later posted data, but it cannot be treated as an independent confirmation. The sit-to-stand test measures a different task and adds another view of physical performance, rather than duplicating the primary measure.

The registry lists other secondary outcomes, including falls, fear of falling, autonomy, and rehospitalization for fall, but the numerical results for those outcomes are not reported in the registry record in the available posted results. The outcome list alone does not show whether the groups differed on those measures.

Unadjusted secondary results carry less weight as evidence because several outcomes and time points can create multiple opportunities for apparently notable findings. No multiplicity strategy or hierarchy of secondary hypotheses is reported in the registry record. The secondary comparisons should therefore be read as descriptive and hypothesis-generating, rather than as a collection of definitive tests. Their interpretation also depends on missingness and analysis choices that are not described in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Score ̏ Timed Up and Go ( TUG ) at 12 Months of SSR Output
• Number of Falls Reported by the Patient
• Number of Falls Reported by the Patient
• Fear of Falling
• Score of Autonomy With the IADL (Instrumental Activities of Daily Living )
• Score of FTSST (Five Timed Sit to Stand Test)
• Score of FTSST (Five Timed Sit to Stand Test)
• Number of re Hospitalization for Fall

9. Statistical Interpretation

10. Statistical Methods Explained

The following explanations describe general statistical ideas relevant to the posted results. The registry record does not report the trial’s original analysis plan, so these explanations should not be read as a description of methods prespecified by the investigators.

What does a group mean describe?

For a continuous outcome such as test time, the mean is the arithmetic average among the participants contributing outcome data. Here the primary outcome is expressed in seconds, and each group has a mean and standard deviation. The mean gives a compact description of the group’s central value. It does not show the individual observations, reveal whether values cluster evenly around the mean, or indicate whether the mean is representative of every participant.

The standard deviation describes how spread out observations are around the group mean. It is not a confidence interval and is not the uncertainty in the difference between group means. A large standard deviation can occur even when a group mean is estimated with reasonable precision if there are enough observations; conversely, a smaller spread does not guarantee a precise comparison when the number of observations is limited. In this trial, the primary standard deviations are 6.4 seconds and 5.0 seconds, alongside group counts of 37 and 39.

How is a mean difference read?

A mean difference compares the group averages in a stated direction. For the primary result, the reported direction is the group without telephone coaching minus the telephone coaching group. The means are 12.9 seconds and 14.8 seconds in that order, and the reported difference is -1.9 seconds. A negative value in this direction means that the first group’s observed mean is lower. If the subtraction order were reversed, the sign would reverse while the underlying contrast would be the same.

General interpretation depends on both the size and the uncertainty of the difference. The point estimate is a single estimate drawn from the observed data. It is not a guarantee that the underlying population difference equals that value. The confidence interval gives a range of values compatible with the data under the method used to construct it. When that range crosses zero, the data are compatible with no mean difference as well as with differences in either direction.

What does a p-value say?

A p-value is a measure of how unusual the observed data, or data more extreme, would be under a specified null model. In a two-group comparison, the null model commonly represents no underlying mean difference. The primary unadjusted p-value is 0.151. It is not the probability that the null hypothesis is true, nor is it the probability that the result occurred by chance. It does not quantify clinical importance, and it does not replace the estimate and its confidence interval.

Statistical significance is often assessed against a chosen threshold, but a threshold does not divide results into proof and disproof. A p-value above a threshold can reflect a small effect, substantial uncertainty, or both. A p-value below a threshold would not by itself establish that an effect is important or that the study’s assumptions are satisfied. The original threshold and analysis procedure are not reported in the registry record; the sample-size planning illustration separately states its assumptions.

Why use a confidence interval?

General statistical practice uses a confidence interval to communicate uncertainty around an estimate. A 95% confidence interval is generated by a procedure designed, under its assumptions, to cover the true parameter in 95% of repeated samples. For an individual study, the interval should not be interpreted as a 95% probability that the fixed true value lies within the calculated bounds. It is a measure of the estimate’s precision under the model and data used.

The primary interval includes zero, which is the value for no mean difference. This is consistent with the unadjusted p-value not being below 0.05. The interpretation is not that the groups have been shown to be the same; rather, the data do not rule out no difference under this comparison, and the range also allows differences in either direction. The same broad caution applies to the posted secondary comparisons.

What does unadjusted mean?

An unadjusted comparison is not adjusted for other variables or for a family of multiple outcome tests. The posted comparisons are described as unadjusted recalculations from group summary statistics. Such a calculation can be useful for understanding the observed contrast, but it may not match a planned model that accounts for baseline values, stratification, repeated measures, or other design features. Whether any such model was planned or used is not reported in the registry record.

Multiple testing matters because examining several outcomes or time points creates more opportunities for a result to appear notable by chance. Adjustment procedures can change the interpretation of p-values or intervals, depending on the prespecified approach. No multiplicity procedure is reported in the registry record. The secondary comparisons should therefore be treated as exploratory descriptions rather than as a set of independent confirmatory tests.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when data vary more than a statistical model assumes. It matters because a model that understates variability can produce uncertainty estimates that are too narrow and significance measures that appear stronger than warranted. The outcomes with numerical comparisons in this trial are continuous and summarized by means and standard deviations; the record does not report an over-dispersion assessment or a model-based variance adjustment. This concept is therefore a general consideration, not a reported feature of the trial analysis.

For continuous outcomes, other assumptions can also affect an unadjusted comparison, including the shape of the outcome distribution and whether observations are independent. The registry record does not report diagnostic checks or a detailed analysis method for the primary outcome. The recalculated comparison is based on the posted group summaries and should be understood as a simple unadjusted result rather than a substitute for a documented trial analysis.

11. Confidence Intervals and Precision

The primary mean difference is -1.9 seconds, with a 95% confidence interval extending from a negative value to a positive value. Because the interval crosses zero, it includes no difference and also allows possible differences in either direction. The interval is therefore not precise enough to identify a single direction for the underlying mean contrast. The unadjusted p-value of 0.151 is consistent with that uncertainty.

Precision depends on the amount of information in the data and the variability of the outcome. The primary summaries include 37 participants in the telephone coaching group and 39 in the group without telephone coaching, with standard deviations of 6.4 seconds and 5.0 seconds. The outcome description also notes missing data for 23 patients. The record does not explain how those missing measurements were addressed, so the implications for precision and potential bias cannot be evaluated from the posted results.

A confidence interval is more informative than a point estimate alone because it conveys the range of values compatible with the observed data under the calculation method. It does not show the probability that a particular treatment effect is true, and its coverage depends on the assumptions behind the method. No prespecified clinical-importance threshold is reported, so the interval cannot be classified against such a threshold using the registry information.

The secondary estimates also have intervals spanning zero. This indicates uncertainty in those comparisons as well. The record does not report adjusted analyses, and the posted comparisons are unadjusted. Precision should therefore be considered together with the number of outcomes and time points assessed, the missing-data information, and the absence of a reported analysis plan.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial’s original design rationale. They assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is the stated fraction of the observed effect. These assumptions are listed for the planning illustration; the trial’s original sample-size assumptions are not reported in the registry record.

The figures for these continuous outcomes are participants per arm, not total participants or total events. The 80% power column gives the estimated number of participants in each arm under the stated assumptions for a design with an 80% chance of detecting the assumed effect if that effect were the true one. The 90% power column expresses the same idea with a higher target chance of detection, which generally requires more participants under the same assumptions.

Planning for 100% of the observed effect, 75% of the observed effect, or 50% of the observed effect illustrates how the assumed effect size changes the required sample. A smaller effect is harder to distinguish from random variation, so it requires more participants for the same power target. The figures should not be read as a statement about what the trial actually achieved, and this is not observed power.

These calculations are sensitive to the observed effect used as their starting point. In a small study, an observed effect may be imprecise, so planning solely from that estimate can be unstable. The illustrations are most useful as conditional planning scenarios: they show the sample sizes implied by the specified assumptions and effect fractions, rather than establishing an appropriate design for a future study.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -1.900; pooled standard deviation σ = 5.724.
2. n = 2 × (1.96 + 0.842)² × 5.724² / -1.900² = 142.5, rounded up to 143 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1.9                      # observed difference in means
sigma <- 5.72401295633792                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2828826)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 143 (80% power), 191 (90% power)
 75% of observed effect: n per arm = 254 (80% power), 340 (90% power)
 50% of observed effect: n per arm = 570 (80% power), 763 (90% power)
power.t.test: 143.4 
Simulated power at n = 143 per arm: 0.794 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes and includes results at more than one assessment time. Testing many outcomes or time points can increase the chance of at least one apparently unusual result even when there is no underlying effect. Statistical methods can account for this multiplicity, for example by controlling the overall error rate or by defining a prespecified hierarchy of tests. No such method is reported in the registry record, and no reported analyses are listed for the secondary outcomes.

The available numerical comparisons are unadjusted. They should not be treated as confirmatory evidence across outcomes without knowing whether the primary and secondary analyses, hypotheses, and multiplicity procedures were prespecified. The analysis plan and the original statistical methods are not reported in the registry record. It is also not reported whether baseline outcome values, other covariates, or repeated measurements were included in any planned analysis.

Missing data are a central limitation for the primary endpoint. The outcome description notes missing data for 23 patients, and the posted primary summaries include 37 participants in the telephone coaching group and 39 in the group without telephone coaching. The record does not explain why measurements were missing, whether missingness differed by group, or how missing outcomes were handled. It does not report whether an imputation method, complete-case approach, or sensitivity analysis was used.

Missingness can affect both precision and the validity of a comparison. If participants with missing measurements differ systematically from those with observed measurements, the observed group summaries may not represent all randomized participants. This is a general concern, not a claim that such bias occurred in this trial. The registry information does not permit the missing-data assumptions to be assessed.

The posted information also does not define the analysis population, such as whether results follow assignment regardless of treatment received. No interim analysis information is reported. Without those details, interpretation is appropriately limited to the observed summaries and unadjusted recalculations, rather than assuming a particular prespecified analysis process.

15. 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 5% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: cancer (2.0%), multivisceral failure (2.0%).

The serious adverse event summaries list 50 participants at risk in the telephone coaching group and 49 in the group without telephone coaching. One serious adverse event is recorded in each group. The listed counts for other adverse events are zero in both groups. One death is recorded in the telephone coaching group and none in the group without telephone coaching.

The record identifies Cancer and multivisceral failure as the top serious terms, each reported as 2.0%. It does not give enough detail in the posted information to connect these terms to a specific group or to establish their relationship to the listed serious-event counts. The registry record also does not describe event timing, severity beyond the serious classification, relatedness to the intervention, or how events were collected.

These counts are descriptive and should not be interpreted as evidence that coaching caused or prevented an event. The groups are limited in size, and the record does not provide an adjusted safety comparison or further context for the events. The figures summarize what is posted, not a complete assessment of safety or causality.

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

The primary result describes observed average test times among participants with posted 6-month data. The mean was 14.8 seconds for telephone coaching and 12.9 seconds for no telephone coaching, with a reported mean difference of -1.9 seconds in the direction of no coaching minus coaching. The uncertainty interval crosses zero, and the unadjusted p-value is 0.151. The data therefore do not establish a clear difference between assigned groups on this outcome.

This result does not demonstrate that the groups are equivalent. Equivalence requires a prespecified margin defining how much difference would be considered acceptably small, together with an analysis designed to test that question. No equivalence margin or equivalence analysis is reported in the registry record. A result that is not statistically significant is not, by itself, evidence that the two approaches have the same effect.

The result also does not establish whether the observed difference is clinically important. The registry record does not report a threshold for meaningful change on the Timed Up and Go test for this study population. A test-time difference should not be interpreted as a change in falls, independence, or quality of life unless those outcomes are measured and their results are available. The listed secondary outcome names do not supply those results.

Nor does the group comparison establish what happened to each participant, whether coaching was received as planned, or whether the intervention changed exercise behavior. The record describes planned physiotherapist calls but does not report adherence to the calls or a dose-response analysis. The assigned-group summaries cannot answer those separate questions.

Finally, the available result does not establish generalizability beyond the study’s participants and setting. Enrollment was 101, the trial status is terminated, and outcome data are missing for 23 patients according to the primary outcome description. The reason for termination, missing-data handling, detailed eligibility criteria, and original statistical plan are not reported in the registry record. These limits mean the posted numbers should be interpreted as an uncertain comparison, not as a definitive judgment about the intervention.

17. Why This Trial Matters Statistically

This trial illustrates why a point estimate should be read together with its uncertainty. The primary observed means differ, but the confidence interval includes zero and the unadjusted p-value is 0.151. Focusing only on the direction or size of the point estimate would miss the uncertainty in what the data can support.

It also shows the importance of distinguishing outcome summaries from a full analysis report. The registry record gives means, standard deviations, sample counts, and unadjusted comparisons, but does not report the original analysis plan or analyses beyond the posted summaries. Those details matter when assessing how the comparison was selected, whether repeated measures or baseline factors were accounted for, and how missing outcomes were treated.

The primary outcome description notes missing data for 23 patients. The missing-data approach is not reported, so readers cannot determine whether the reported comparison reflects all randomized participants or only those with observed outcomes under a defined analysis strategy. Transparent reporting of analysis populations, missingness, and sensitivity analyses would help readers assess the robustness of the result.

The trial also provides a useful example of why secondary outcomes require caution. Several outcomes and times are listed, but no multiplicity strategy is reported. Unadjusted comparisons across a set of outcomes have a different evidential role from a single prespecified primary comparison. Keeping that distinction clear prevents exploratory patterns from being overstated.

Finally, sample-size planning depends on assumptions about the effect worth detecting, variability, and the desired power. Planning illustrations based on the observed effect can show how the required sample changes under different effect assumptions, but they do not reveal the original design rationale or the study’s observed power. Those original design assumptions are not reported in the registry record.

18. 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 primary analysis is difficult to assess fully because the registry record does not report the original statistical plan, analysis population, or treatment of missing outcomes. The primary outcome description notes missing data for 23 patients, but gives no account of why those data are missing or whether the pattern differed between groups. The posted summaries may therefore be affected by uncertainty about which participants contributed measurements.

The trial status is terminated, but the reason for termination is not reported. This makes it difficult to understand whether the study ended as planned or whether recruitment, follow-up, or other operational factors affected the available results. The record lists enrollment of 101, while the primary outcome summaries include 37 and 39 participants in the two groups; no reconciliation of the different counts is reported.

The intervention description says the physiotherapist programmed 5 calls, but it is truncated and does not fully describe call content or delivery. The record does not report whether participants completed the planned calls, or whether adherence to the home exercise program was measured. This limits the ability to distinguish the effect of assignment from the effect of actually receiving coaching.

The record reports no masking. It does not describe whether outcome assessors were masked, so the masking of the timed assessment cannot be determined. The comparator is identified as no telephone coaching, but the record does not fully describe other follow-up or support received by either group.

Finally, the numerical secondary results are limited, and the record does not report results for several listed outcomes. No multiplicity approach, interim analysis plan, or clinically important threshold is reported. These reporting gaps, alongside the missing-data uncertainty and the unadjusted nature of the available comparisons, warrant a restrained interpretation of the observed results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home — NCT02828826.
• Registry record last updated 2026-10-26; status last verified 2026-06.
• Results first posted 2026-10-26.
• 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.

22. Record Summary

NCT02828826 is a randomized, parallel-group trial with no masking, listed as terminated, and with enrollment of 101. It compared telephone coaching by a physiotherapist with no telephone coaching among older patients living at home in a physical exercise maintenance program. The registry lists Nantes University Hospital as sponsor.

The primary endpoint was Timed Up and Go time at 6 months. The group means were 14.8 seconds with coaching and 12.9 seconds without coaching. The unadjusted mean difference was -1.9 seconds for no coaching minus coaching; its confidence interval crossed zero, and the unadjusted p-value was 0.151. The primary outcome description notes missing data for 23 patients.

Posted secondary comparisons include Timed Up and Go at 12 months and the Five Timed Sit to Stand Test at 6 months. Their confidence intervals also cross zero. The registry record does not report the original statistical plan, missing-data handling, multiplicity strategy, or reason for termination, which limits interpretation of the posted comparisons.