What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study)

Abstract

Objective Performance measures provide important information, but the meaning of change in these measures is not well known. The purpose of this research is to 1) examine the effect of treatment assignment on the relationship between self-report and performance; 2) to estimate the magnitude of meaningful change in 400-meter walk time (400MWT), 4-meter gait speed (4MGS), and Short Physical Performance Battery (SPPB) and 3) to evaluate the effect of direction of change on estimates of magnitude. Design This is a secondary analysis of data from the LIFE-P study, a single blinded randomized clinical trial. Using change over one year, we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT, 4MGS and SPPB. Setting Four university-based clinical research sites. Participants Sedentary adults aged 70–89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline (n=424). Interventions A structured exercise program versus health education. Measurements 400MWT, 4MGS, SPPB. Results Relationships between self-report and performance measures were consistent between treatment arms. Minimally significant change estimates were 400MWT: 20–30 seconds, 4MGS: 0.03–0.05m/s and SPPB: 0.3 – 0.8 points. Substantial changes were 400MWT: 50–60 seconds, 4MGS: 0.08m/s, SPPB: 0.4 – 1.5 points. Magnitudes of change for improvement and decline were not significantly different. Conclusions The magnitude of clinically important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise. Due to limited power, the effect of direction of change on estimates of magnitude remains uncertain.

Muscle function, physical performance and body composition changes in men with prostate cancer undergoing androgen deprivation therapy

“…31,[42][43][44][45][46][47][48] Criteria for small and substantial meaningful change scores have been established. 49,50 Baseline SPPB scores in men with PCa suggest normally functioning individuals (scores greater than 9 out of 12 possible), but with a tendency for men with longer ADT exposure to have slightly lower scores compared with control groups. Notably, one cross-sectional study reported an SPPB score of 7.9 in men averaging 36 months of ADT.…”

“…This .1 point difference from baseline is suggestive of a substantial meaningful change. 49,50 Men who had an average of 4 months of ADT at baseline as well as men with PCa not receiving ADT or HC changed by 0.42 and 0.17 points in SPPB, respectively, over the 24-month study period. Neither baseline values nor changes after 24 months were significantly different between groups.…”

“…The improvement in usual pace walk speed from 1.2 to 1.4 m s 21 exceeds the 0.1 m s 21 improvement criteria for substantial meaningful change. 49,50 Subsequently, in a larger, cross-sectional evaluation, Galvao et al…”

Effects of a structured physical activity intervention on measures of physical performance in frail elderly patients after cardiac rehabilitation: a pilot study with 1-year follow-up

“…We regarded as clinically relevant a difference of the SPPB score equal or greater than 1 point, which is considered a substantial change in the pertinent literature [21,22].…”

Untitled

“…We therefore suggest reporting mean ± SD/SE as a standard minimum. Relative changes may be reported, to further contextualise findings in relation to a minimum meaningful change from baseline [91]. Regarding the minimum meaningful change, it may be useful to refer to the critical difference of sa-T and sal-C to determine whether changes observed are biologically meaningful [79,145].…”