Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol.

BACKGROUND: Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits. METHODS: We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps. CONCLUSION: If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints. TRIAL REGISTRATION: The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.

Preoperative walking intervention did not appear to improve patient-reported postoperative recovery in older adults with frailty traits: Randomized trial.

OBJECTIVES: To assess the impact of a preoperative walking intervention on improving postoperative recovery in at-risk frail older adult patients. STUDY TYPE: Unblinded, randomized controlled trial which assigned patients to intervention versus control. POPULATION: Patients aged 60+ scheduled for surgery 3-8 weeks from randomization scoring 4+ on the Edmonton Frail Scale. INTERVENTION: Preoperative walking enhanced by goal setting with an activity monitor and telephonic coaching. MAIN OUTCOMES: Quality of Recovery 9-item instrument total score and a modified version of the Abdominal Surgery Impact Scale total score. RESULTS: A total of 83 patients were analyzed. Postoperative recovery scores were similar in intervention vs control - Quality of Recovery-9 item instrument total score 14.1 vs. 14.1 (P = .94) and modified Abdominal and Surgery Impact Scale total score 82.8 vs. 79.2 (P = .93). Few intervention patients met their daily step count goals. Despite this, intervention patients improved average daily step counts significantly. CONCLUSIONS: Preoperative walking bolstered with activity monitor and remote coaching did not appear to lead to improved postoperative recovery in older adults with frailty traits. Further research is necessary to see if a similar intervention in specific surgery types or a more intense version of the intervention can improve recovery.

Supervised preoperative walking on increasing early postoperative stamina and mobility in older adults with frailty traits: A pilot and feasibility study.

Background and Aims: Frail older adults are more than twice as likely to experience postoperative complications. Preoperative exercise may better prepare these patients through improved stamina and mobility experienced in the days following surgery. We measured the impact of a walking intervention using an activity tracker and coaching on postoperative stamina, and mobility in older adults with frailty traits. Methods: We included patients aged 60+ and scoring 4+ on the Edmonton Frailty Scale. We then randomized patients to intervention versus control stratified by anticipated hospital stay (1 night vs. 2+ night) and baseline stamina (i.e., 6-min walk distance [6MWD]). Intervention patients received an activity tracker and linked smart phone. An athletic trainer (AT) prescribed a daily step count goal and titrated this up after checking in with patients during weekly telephone calls. Controls received general walking recommendations. We then measured postoperative 6MWD 1-3 days after surgery. We also assessed postoperative mobility by measuring steps walked the day after surgery using a thigh-worn monitor. Because many patients could not walk postoperatively, we compared intervention-control difference in both 6MWD and steps using Wilcoxon rank testing and Tobit and ordinal logistic regression adjusting for several patient characteristics. Results: We randomized 104 eligible patients; 80 patients remained for final analysis. There was no difference in intervention versus control postoperative 6MWD (median 72 vs. 74 m Wilcoxon p = 0.54) or postoperative steps taken (median 128 vs. 51 steps Wilcoxon p = 0.76). Analysis adjusting for patient characteristics was consistent with these findings. Conclusion: Our intervention consisting of goal setting with an activity tracker and telephonic coaching by an AT did not appear to improve stamina or mobility measured in the days after surgery. Small sample size limited our ability to examine this impact in subsets defined by surgical specialty or baseline stamina.

Self-Reported Function More Informative than Frailty Phenotype in Predicting Adverse Postoperative Course in Older Adults.

BACKGROUND/OBJECTIVE: Current preoperative assessment tools such as the American College of Surgeons Surgical Risk Calculator (ACS Calculator) are suboptimal for evaluating older adults. The objective was to evaluate and compare the performance of the ACS Calculator for predicting risk of serious postoperative complications with the addition of self-reported physical function versus a frailty score. DESIGN: Prospective cohort. SETTING: Two tertiary care academic medical centers in Massachusetts. PARTICIPANTS: Individuals aged 65 and older undergoing any surgery with a risk of serious complication of 5% or greater (N = 403). MEASUREMENTS: We measured self-reported physical function using the Late-Life Function and Disability Instrument (LLFDI FUNCTION) and frailty phenotype (FP), which has a score ranging from 0 to 5 based on slow gait speed, weak handgrip, exhaustion, weight loss, or low activity. Using c-statistic and net classification improvement (NRI), we then analyzed capability of LLFDI-FUNCTION versus FP to improve the ACS Calculator for predicting an adverse postoperative course (serious complication, discharge to nursing home, readmission, death within 30 days of surgery). Increase in c-statistic and net reclassification improvement (NRI) for LLFDI-FUNCTION versus FP in addition to the ACS Calculator for predicting an adverse postoperative course (serious complication, discharge to nursing home, readmission, death within 30 days of surgery) RESULTS: Over 30 days, 26% of participants developed an adverse postoperative course. The increase in c-statistic for the ACS Calculator (baseline value 0.645) was slightly greater with LLFDI-FUNCTION (0.076) than with FP (0.058), with a bootstrapped difference in c-statistic of 0.005 (95% confidence interval = 0.002-0.007). NRI was also better with LLFDI-FUNCTION. CONCLUSION: The LLFDI-FUNCTION predicted postoperative complications slightly better than the FP. Further studies are needed to confirm these findings and validate the use of the LLFDI-FUNCTION with the ACS Calculator for preoperative assessments of older adults.

Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients.

INTRODUCTION: Immobilisation in the intensive care unit (ICU) leads to muscle weakness and is associated with increased costs and long-term functional disability. Previous studies showed early mobilisation of medical ICU patients improves clinical outcomes. The Surgical ICU Optimal Mobilisation Score (SOMS) trial aims to test whether a budget-neutral intervention to facilitate goal-directed early mobilisation in the surgical ICU improves participant mobilisation and associated clinical outcomes. METHODS AND ANALYSIS: The SOMS trial is an international, multicentre, randomised clinical study being conducted in the USA and Europe. We are targeting 200 patients. The primary outcome is average daily SOMS level and key secondary outcomes are ICU length of stay until discharge readiness and 'mini' modified Functional Independence Measure (mmFIM) at hospital discharge. Additional secondary outcomes include quality of life assessed at 3 months after hospital discharge and global muscle strength at ICU discharge. Exploratory outcomes will include: ventilator-free days, ICU and hospital length of stay and 3-month mortality. We will explore genetic influences on the effectiveness of early mobilisation and centre-specific effects of early mobilisation on outcomes. ETHICS AND DISSEMINATION: Following Institutional Review Board (IRB) approval in three institutions, we started study recruitment and plan to expand to additional centres in Germany and Italy. Safety monitoring will be the domain of the Data and Safety Monitoring Board (DSMB). The SOMS trial will also explore the feasibility of a transcontinental study on early mobilisation in the surgical ICU. RESULTS: The results of this study, along with those of ancillary studies, will be made available in the form of manuscripts and presentations at national and international meetings. REGISTRATION: This study has been registered at clinicaltrials.gov (NCT01363102).