Triangulating Clinically Meaningful Change in the Six-minute Walk Test in Individuals with Chronic Heart Failure: A Systematic Review.

PURPOSE: The purpose of the present review was to use existing, published data to provide an estimate of the amount of change in six-minute walk test distance (Δ6MWT) that represents a clinically meaningful change in individuals with chronic heart failure (CHF).

METHODS: THE PRESENT REVIEW INCLUDED TWO SEPARATE LITERATURE SEARCHES OF THE CINAHL AND MEDLINE DATABASES FOR ARTICLES THAT: (1) reported the intraclass correlation coefficient (ICC) of the 6MWT in individuals with CHF, and (2) used the 6MWT along with either aerobic capacity or health-related quality of life (HRQL) as study endpoints in randomized controlled trials (RCTs) of exercise-based intervention for individuals with CHF. The ICCs were used to calculate the minimum detectable difference (MDD) at the 95% confidence interval for each included study. The Δ6MWT associated with aerobic capacity and HRQL within-group effect sizes for the intervention and control groups in each included RCT was analyzed using receiver operating characteristic (ROC) curves.

RESULTS: Thirteen articles reported the ICC for the 6MWT. The mean (standard deviation) MDD calculated based on these data was 43.1(16.8) m. Eighteen RCTs measured the 6MWT and either aerobic capacity and/or HRQL. A Δ6MWT of 40-45 m was associated with at least moderate aerobic capacity and HRQL effect sizes in the intervention groups. The Δ6MWT thresholds that discriminated between intervention and control groups using ROC curves revealed the following sensitivity/specificity for the respective thresholds: 19 m, 94.4/83.3%, 32 m, 83.3/94.4%, and 48 m 44.4/100% (AUC = .935, p = .009, CI(95%) .855, 1.015).

CONCLUSIONS: A Δ6MWT of approximately 45 m appears to exceed measurement error and be associated with significant changes in either aerobic capacity and/or HRQL.