Background and Objectives:
Impaired physical functioning is common and long lasting after an intensive care unit (ICU) admission. The 6-minute walk test (6MWT) is a validated and widely used test of ...functional capacity. This systematic review synthesizes existing data in order to: (1) evaluate 6-minute walk distance (6MWD) in meters over longitudinal follow-up after critical illness, (2) compare 6MWD between acute respiratory distress syndrome (ARDS) versus non-ARDS survivors, and (3) evaluate patient- and ICU-related factors associated with 6MWD.
Data Sources:
Five databases (PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature, PsychINFO, and Cochrane Controlled Trials Registry) were searched to identify studies reporting 6MWT after hospital discharge in survivors from general (ie, nonspeciality) ICUs. The last search was run on February 14, 2018. Databases were accessed via Johns Hopkins University Library.
Data Extraction and Synthesis:
Pooled mean 6MWD were reported, with separate linear random effects models used to evaluate associations of 6MWD with ARDS status, and patient- and ICU-related variables. Twenty-six eligible articles on 16 unique participant groups were included. The pooled mean (95% confidence interval CI) 6MWD results at 3- and 12-months post discharge were 361 (321-401) and 436 (391-481) meters, respectively. There was a significant increase in 6MWD at 12 months compared to 3 months (P = .017). In ARDS versus non-ARDS survivors, the mean (95% CI) 6MWD difference over 3-, 6-, and 12-month follow-up was 73 13-133 meters lower. Female sex and preexisting comorbidity also were significantly associated with lower 6MWD, with ICU-related variables having no consistent associations.
Conclusions:
Compared to initial assessment at 3 months, significant improvement in 6MWD was reported at 12 months. Female sex, preexisting comorbidity, and ARDS (vs non-ARDS) were associated with lower 6MWT results. Such factors warrant consideration in the design of clinical research studies and in the interpretation of patient status using the 6MWT.
The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH).
6MWD is used as an endpoint ...to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown.
Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes.
Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio OR: 0.429; 95% confidence interval CI: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected.
In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes.
The six-minute walk test (6MWT) can assess walking function but is time-consuming. We investigate the correlation of performance over the first two minutes of the 6MWT (2MWT#) and the 6MWT. We also ...evaluate the 2MWT#'s ability to predict 6MWT results, assess correlations to secondary explanatory outcomes, and assess the ability to discriminate between clinical subgroups.
A cross-sectional study of 124 participants with LBP. Correlations between the 2MWT# and 6MWT and secondary outcomes were evaluated using the Pearson product-moment correlation coefficient. The predictive ability of the 2MWT# was defined as the residual distance between the observed 6MWT and three times the 2MWT#. Differences between clinical subgroups were evaluated using the Wilcoxon rank test.
The 2MWT# and 6MWT correlated highly (r = 83, 95% CI 0.76 − 0.87). The 2MWT# overestimated 6MWT results with 46.8 meters (SD 67.0). Both tests correlated with secondary outcomes and discriminated similarly between clinical subgroups.
The 2MWT# correlates highly with 6MWT but overestimates the observed 6MWT by 9%. Because it is shorter, possibly less burdensome, and with little or no loss of discriminatory ability, we consider it a legitimate alternative to the 6MWT in patients with LBP.
Implications for rehabilitation
Walking function is often affected in patients with low back pain (LBP).
The six-minute walk test (6MWT) is frequently used to assess walking function but is time-consuming.
A shorter two-minute walk test is a legitimate alternative in patients with LBP as it correlates highly with the 6MWT and has little or no loss of discriminatory ability between clinical subgroups.
Background
The 6‐minute walk test (6MWT) is a simple and inexpensive way of measuring exercise capacity in patients with heart failure (HF) that predicts morbidity and mortality. However, there are ...few reports from large multicentre cohorts assessing the predictive value of baseline and changing walk distance.
Methods and results
In BIOSTAT‐CHF, a 6MWT was performed at baseline (n = 1714) and 9 months (n = 1520). Cox proportional hazards models were used to assess the associations between 6MWT distance and the composite of HF hospitalization and/or death. Median follow‐up was 21 months. The median (pct25‐75) of the 6MWT distance at baseline was 300 m (200–388 m). Independent predictors of a shorter 6MWT distance included older age, female sex, higher heart rate, New York Heart Association class III/IV, orthopnoea, ischaemic heart disease, a previous stroke, current malignancy, and higher N‐terminal pro‐B‐type natriuretic peptide (all P < 0.05). Patients in the lowest baseline 6MWT tertile (≤ 240 m) were less likely to receive guideline‐recommended doses of disease‐modifying therapies (P < 0.05). Compared to patients in the highest baseline 6MWT tertile (> 360 m), those in the lowest and middle tertiles had a worse prognosis adjusted hazard ratio (HR) 1.73, 95% confidence interval (CI) 1.38–2.18. Patients with a decrease in the distance walked had a worse prognosis (adjusted HR for each 50 m decrease 1.09, 95% CI 1.06–1.12). 6MWT distance was not modified by treatment up‐titration nor the 6MWT improved the BIOSTAT‐CHF prognostic models.
Conclusions
The 6‐minute walk test distance at baseline and a decline in walking distance were both associated with worse prognosis but did not improve the prognostic models. 6MWT distance was not modified by treatment up‐titration and its use for assessing the benefits of pharmacologic treatment up‐titration may be limited.
•The PROACTIVE-HF trial is designed to assess the benefit of personalized and proactive management of patients with class III heart failure (HF) guided by daily measurements of pulmonary artery ...pressure (PAP) pressures in combination with weight, blood pressure, heart rate, blood oxygen saturation, and symptoms.•The investigational Cordella Sensor System is designed to achieve high levels of patient engagement and compliance by the use of a small hand-held reader placed over an anteriorly implanted sensor, facilitating patient-friendly seated PAP measurements and a modern digital health app providing patients with timely education, real-time feedback and tools for easy 2-way communication with the care providers.•Key trial hypotheses are that HF management using PAP in combination with additional vital-sign parameters will provide the dual benefits of congestion management and GDMT optimization and that patient engagement and compliance will positively impact remote medical management decisions and patient outcomes.
Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in patients with heart failure (HF) are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management.
The PROACTIVE-HF study was originally approved in 2018 as a prospective, randomized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System.
The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.
Abstract
Background
Recovery of function and regaining muscle strength are challenging after hip fracture. We compared the effectiveness of a 12- versus 6-week outpatient physical therapy program ...with progressive resistive training (PRT) to increase strength and physical performance.
Methods
This parallel, superiority, 2-group randomized controlled trial was conducted in 4 clinics that enrolled community-dwelling, cognitively intact older adults (+60 years) with a surgical repair of a hip fracture and no major medical conditions. Participants received 12 or 6 weeks of PRT and standardized physical therapy, twice weekly. Pain was monitored throughout. Primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 12-week follow-up. Randomization via a computer-generated allocation sequence was implemented using sealed, sequentially numbered opaque envelopes and assessors were blinded to group assignment.
Results
Participants (81% women) with a mean (SD) age of 77 (8.1) years were enrolled at an average of 18 days after hip fracture surgery and randomized into a 12-week group (n = 50) or a 6-week group (n = 50). Mean (SD) change scores in the 6MWT were 143.8 (81.1) and 161.5 (84.1) m in the 12- and 6-week groups, respectively (both exceeding the minimal clinically important difference of 55 m). The mean between-group difference was −17.7 m (95% CI −50.1, 14.8). Pain during training did not exceed moderate levels nor increase as training intensity increased.
Conclusion
Twelve weeks of physical therapy with PRT was not superior to 6 weeks in improving walking distance. Hip fracture-related pain was relatively low and indicated strength testing and training was well tolerated.
Clinical Trials Registration Number: NCT01174589
ABSTRACT
Introduction: Duchenne muscular dystrophy (DMD) subjects ≥5 years with nonsense mutations were followed for 48 weeks in a multicenter, randomized, double‐blind, placebo‐controlled trial of ...ataluren. Placebo arm data (N = 57) provided insight into the natural history of the 6‐minute walk test (6MWT) and other endpoints. Methods: Evaluations performed every 6 weeks included the 6‐minute walk distance (6MWD), timed function tests (TFTs), and quantitative strength using hand‐held myometry. Results: Baseline age (≥7 years), 6MWD, and selected TFT performance are strong predictors of decline in ambulation (Δ6MWD) and time to 10% worsening in 6MWD. A baseline 6MWD of <350 meters was associated with greater functional decline, and loss of ambulation was only seen in those with baseline 6MWD <325 meters. Only 1 of 42 (2.3%) subjects able to stand from supine lost ambulation. Conclusion: Findings confirm the clinical meaningfulness of the 6MWD as the most accepted primary clinical endpoint in ambulatory DMD trials. Muscle Nerve 48: 343–356, 2013
The 6-Minute Walk Test (6MWT) is a common performance-measure in Knee Osteoarthritis (KOA), but the pain and functional impairment characterizing the condition may interfere its adequate performance.
...The shorter 10-m Walk Test (10mWT) could predict the distance performed on the 6MWT, therefore decreasing the burden on patients, enhancing efficiency, and reducing space- and time-constraints in clinical settings.
A cross sectional study was conducted.
The scores from the 6MWT and the shorter 10mWT of 58 ambulatory subjects with KOA were compared. Correlation, and a univariate regression analysis to explore the predictive ability of the 10mWT, were calculated.
Correlation was excellent (r = 0.913, p-value<0.001), and the predictive equation based on the 10mWT scores (R2 = 0.834, p-value<0.001) estimates the distance walked in the 6MWT with a relative error of 7.62%.
The 10mWT may be an excellent assessment-tool to predict the distance walked in the 6MWT, due to its low strain on patients and as a means of improving efficiency and reducing time-constraints.
•This is the first study to explore the predictive ability of 10mWT versus 6MWT.•The high correlation 10mWT-6MWT supports a good concurrent validity in KOA.•Equation for estimating the actual performance of 6MWT = 48.09 + 321 * 10mWT.•The 10mWT can be a practical tool to estimate the predictive distance walked in the 6MWT in clinical settings.•The 10mWT improves space- and time-constraints in clinical settings.
Novel therapies for idiopathic pulmonary fibrosis (IPF) are in development, but there remains uncertainty about the optimal trial endpoint. An earlier endpoint would enable assessment of a greater ...number of therapies in adaptive trial designs.
To determine whether short-term changes in FVC, Dl
, and six-minute-walk distance could act as surrogate endpoints to accelerate early-phase trials in IPF.
Individual participant data (IPD) from IPF clinical trials were included in a two-step random-effects meta-analysis to determine whether baseline or 3-month changes in FVC, Dl
, and 6-minute-walk distance were associated with mortality or disease progression in placebo arms. Three-month and 12-month FVC decline endpoints were compared with treatment arm data from antifibrotic studies by meta-regression.
IPD were available from 12 placebo cohorts totaling 1,819 participants, with baseline and 3-month changes in all physiological variables independently associated with poorer outcomes. Treatment data were available from six cohorts with 1,684 participants. For each 2.5% relative decline in FVC over 3 months, there was an associated 15% (adjusted hazard ratio, 1.15; 95% confidence interval CI, 1.06-1.24;
= 59.4%) and 20% (adjusted hazard ratio, 1.20; 95% CI, 1.12-1.28;
= 18.0%) increased risk for mortality in untreated and treated individuals, respectively. An FVC change treatment effect was observed between treatment and placebo arms at 3 months (difference in FVC change of 42.9 ml; 95% CI, 24.0-61.8 ml;
< 0.001).
IPD meta-analysis demonstrated that 3-month changes in physiological variables, particularly FVC, were associated with mortality among individuals with IPF. FVC change over 3 months may hold potential as a surrogate endpoint in IPF adaptive trials.
PDF
