Multimodal Prehabilitation to Enhance Functional Capacity Following Radical Cystectomy: A Randomized Controlled Trial.

BACKGROUND: In patients with bladder cancer, poor functional status has remarkable deleterious effects on postoperative outcome and prognosis. Conditioning intervention initiated before surgery has the potential to reduce functional decline attributable to surgery. Nonetheless, evidence is lacking in patients undergoing radical cystectomy. OBJECTIVE: To determine whether a preoperative multimodal intervention (prehabilitation) is feasible and effective in radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS: This study, conducted at an academic tertiary health care institution, enrolled adult patients scheduled for radical cystectomy. From August 2013 to October 2017, 70 patients were randomized: 35 to multimodal prehabilitation (prehab group) and 35 to standard care (control group). INTERVENTION: Multimodal prehabilitation was a preoperative conditioning intervention including aerobic and resistance exercise, diet therapy, and relaxation techniques. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was perioperative change in functional capacity, measured with the distance covered during a 6-min walk test (6MWD), assessed at baseline, before surgery, and at 4 and 8 wk after surgery. Data were compared using robust mixed linear models for repeated measures. RESULTS AND LIMITATIONS: Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250). However, at 4 wk after surgery, a significant difference in functional capacity was detected (6MWD, prehab group -15.4 [142.5] m vs control group -97.9 [123.8] m, p=0.014). No intervention-related adverse effects were reported. CONCLUSIONS: Data suggested that multimodal prehabilitation resulted in faster functional recovery after radical cystectomy. PATIENT SUMMARY: After major cancer surgery, people usually feel week and tired, and have less energy to perform activities of daily living. In this study, we showed that using the time before surgery to promote exercise and good nutrition could fasten recovery after the surgical removal of the bladder.

Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications.

INTRODUCTION: Recent efforts to prehabilitate intermediately frail and frail (Fried frailty criteria ≥2) elective colorectal cancer patients did not influence clinical nor functional outcomes. The objective of this secondary analysis was to describe the subset of intermediately frail and frail prehabilitated patients who could not attain a minimum 400 m (a prognostic cut-point used in other patient populations) 6-min walking distance (6MWD) before elective surgery. MATERIALS AND METHODS: Secondary analysis of a randomized controlled trial. Patients participated in multimodal prehabilitation at home and in-hospital for approximately four weeks before colorectal surgery. Primary outcome was incidence of postoperative complications within 30 days of hospital discharge. RESULTS: Sixty percent of the patients who participated in prehabilitation did not reach a minimum walking distance of 400 m in 6 min before surgery. Compared to the group that attained ≥400 m 6MWD (n = 19), the <400 m group (n = 28) were older, had higher percent body fat, lower physical function, lower self-reported physical activity, higher American Society of Anesthesiologists (ASA) classification, and twice as many were in critical need of a nutrition intervention at baseline. No group differences were observed regarding frailty status (P = 0.775). Sixty-one percent of the <400 m 6MWD group experienced at least one complication within 30 days of surgery compared to 21% in the ≥400 m group (P = 0.009). CONCLUSION: Several preoperative characteristics were identified in the <400 m 6MWD group that could be useful in screening and targeting future prehabilitative treatments. Future trials should investigate use of a 400 m standard for the 6MWD as a minimal treatment target for prehabilitation.

Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.

Importance: Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes. Objective: To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation. Design, Setting, and Participants: This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019. Interventions: Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway. Main Outcomes and Measures: The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures. Results: Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups. Conclusions and Relevance: In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively. Trial Registration: ClinicalTrials.gov identifier: NCT02502760.

Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT.

BACKGROUND: Physical activity via early mobilization after surgery is recommended to help reduce the risk of postoperative adverse effects and to improve recovery. We explored whether prehabilitation is associated with differences in physical activity during the postoperative inpatient stay and the week after discharge in men undergoing abdominal surgery. METHODS: This study was a pre-planned secondary analysis of a larger randomized controlled trial of home-based exercise prehabilitation versus control for men undergoing radical prostatectomy. Twenty-one participants in both the prehabilitation and control groups wore accelerometers from postoperative day 1 until 7 days after discharge. Mean physical activity (minutes) during postoperative day 1 (inpatient) and 1 week following hospital discharge (outpatient) were estimated using ANCOVA. Pearson's correlation coefficients were conducted for mean in- an outpatient physical activity with length of stay and changes in 6-min walk test (6MWT) over the course of the prehabilitation period. RESULTS: Nineteen participants in each group provided usable accelerometry data for analysis. Inpatient physical activity of light or greater activity during postoperative day 1 for prehabilitation and control groups were 442.5 ± 40.2 and 324.0 ± 40.2 min, respectively (∆ = 117.5 ± 57.8 min, 95%CI [0.04, 235.0]). During the outpatient period, mean daily physical activity was 448.4 ± 31.2 and 491.42 ± 31.2 min for prehabilitation and control participants, respectively (∆ = 42.6 ± 44.9 min; 95% CI [- 134.0, 48.7]). There were no correlations between in- or outpatient physical activity and preoperative changes in 6MWT or length of stay. CONCLUSIONS: Accelerometry-based measurement of physical activity in the acute postoperative period is feasible in older men undergoing abdominal surgery. Prehabilitation may be associated with increased inpatient physical activity; however, larger and longer studies are needed to elucidate any associated effects on clinical and patient outcomes. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02036684 registered January 15, 2014.

The impact of improved functional capacity before surgery on postoperative complications: a study in colorectal cancer.

Background: Poor functional capacity (FC) is an independent predictor of postoperative morbidity. However, there is still a lack of evidence as to whether enhancing FC before surgery has a protective effect on postoperative complications. The purpose of this study was to determine whether an improvement in preoperative FC impacted positively on surgical morbidity. Methods: This was a secondary analysis of a cohort of patients who underwent colorectal resection for cancer under Enhanced Recovery After Surgery care. FC was assessed with the 6-min walk test, which measures the distance walked in 6 min (6MWD), at 4 weeks before surgery and again the day before. The study population was classified into two groups depending on whether participants achieved a significant improvement in FC preoperatively (defined as a preoperative 6MWD change ≥19 meters) or not (6MWD change <19 meters). The primary outcome measure was 30-d postoperative complications, assessed with the Comprehensive Complication Index (CCI). The association between improved preoperative FC and severe postoperative complication was evaluated using multivariable logistic regression. Results: A total of 179 eligible adults were studied: 80 (44.7%) improved in 6MWD by ≥19 m preoperatively, and 99 (55.3%) did not. Subjects whose FC increased had lower CCI (0 [0-8.7] versus 8.7 [0-22.6], p = .022). Furthermore, they were less likely to have a severe complication (adjusted OR 0.28 (95% CI 0.11-0.74), p = .010), and to have an ED visit. Conclusion: Improved preoperative FC was independently associated with a lower risk of severe postoperative complications. Further investigation is required to establish a causative relationship conclusively.

Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial.

INTRODUCTION: Preoperative exercise and fitness are predictors of surgical recovery; however, little is known of the effect of preoperative exercise-based conditioning, known as prehabilitation, in this for men undergoing radical prostatectomy. Our study examined the feasibility and effects of prehabilitation on perioperative and postoperative outcomes in men undergoing radical prostatectomy. METHODS: This feasibility RCT compared prehabilitation (PREHAB) versus a control condition (CON) in 86 men undergoing radical prostatectomy. PREHAB consisted of home-based, moderate-intensity exercise prior to surgery. Both groups received a preoperative pelvic floor training regimen. Feasibility was assessed via rates of recruitment, attrition, intervention duration and adherence, and adverse events. Clinical outcomes included surgical complications, and length of stay. The following outcomes were assessed at baseline, prior to surgery, and 4, 12, and 26-weeks postoperatively: 6-min walk test (6MWT), upper-extremity strength, quality of life, psychosocial wellbeing, urologic symptoms, and physical activity volume. RESULTS: The recruitment rate was 47% and attrition rates were 25% and 33% for PREHAB and CON, respectively. Adherence to PREHAB was 69% with no serious intervention-related adverse events. After the intervention and prior to surgery, PREHAB participants demonstrated less anxiety (P = 0.035) and decreased body fat percentage (P = 0.001) compared to CON. Four-weeks postoperatively, PREHAB participants had greater 6MWT scores of clinical significance compared to CON (P = 0.006). Finally, compared to CON, grip strength and anxiety were also greater in the PREHAB at 26-weeks (P = 0.022) and (P = 0.025), respectively. CONCLUSION: While feasible and safe, prehabilitation has promising benefits to physical and psychological wellbeing at salient timepoints relative to radical prostatectomy.

Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial.

BACKGROUND: Prehabilitation has been previously shown to be more effective in enhancing postoperative functional capacity than rehabilitation alone. The purpose of this study was to determine whether a weekly supervised exercise session could provide further benefit to our current prehabilition program, when comparing to standard post-surgical rehabilitation. METHODS: A parallel-arm single-blind randomized control trial was conducted in patients scheduled for non-metastatic colorectal cancer resection. Patients were assigned to either a once weekly supervised prehabilitation (PREHAB+, n = 41) or standard rehabilitation (REHAB, n = 39) program. Both multimodal programs were home-based program and consisted of moderate intensity aerobic and resistance exercise, nutrition counseling with daily whey protein supplementation and anxiety-reduction strategies. Perioperative care was standardized for both groups as per enhanced recovery after surgery (ERAS®) guidelines. Functional exercise capacity, as determined by the 6-minute walk test distance (6MWD), was the primary outcome. Exercise quantity, intensity and energy expenditure was determined by the CHAMPS questionnaire. RESULTS: Both groups were comparable for baseline walking capacity (PREHAB+: 448 m [IQR 375-525] vs. REHAB: 461 m [419-556], p=.775) and included a similar proportion of patients who improved walking capacity (>20 m) during the preoperative period (PREHAB+: 54% vs. REHAB: 38%, p = .222). After surgery, changes in 6MWD were also similar in both groups. In PREHAB+, however, there was a significant association between physical activity energy expenditure and 6MWD (p < .01). Previously inactive patients were more likely to improve functional capacity due to PREHAB+ (OR 7.07 [95% CI 1.10-45.51]). CONCLUSIONS: The addition of a weekly supervised exercise session to our current prehabilitation program did not further enhance postoperative walking capacity when compared to standard REHAB care. Sedentary patients, however, seemed more likely to benefit from PREHAB+. An association was found between energy spent in physical activity and 6MWD. This information is important to consider when designing cost-effective prehabilitation programs.

Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience.

BACKGROUND: Multimodal prehabilitation is a preoperative conditioning intervention in form of exercise, nutritional assessment, whey protein supplementation, and anxiety-coping technique. Despite recent evidence suggesting that prehabilitation could improve functional capacity in patients undergoing colorectal surgery for cancer, all studies were characterized by a relatively small sample size. The aim of this study was to confirm what was previously found in three small population trials. MATERIAL AND METHODS: Data of 185 participants enrolled in a pilot single group study and two randomized control trials conducted at the McGill University Health Center from 2010 to 2015 were reanalyzed. Subjects performing trimodal prehabilitation (exercise, nutrition, and coping strategies for anxiety) were compared to the patients who underwent the trimodal program only after surgery (rehabilitation/control group). Functional capacity was assessed with the six-minute walk test (6MWT), a measure of the distance walked over six minutes (6MWD). A significant functional improvement was defined as an increase in 6MWD from baseline by at least 19 m. Changes in 6MWD before surgery, at four and eight weeks were compared between groups. RESULTS: Of the total study population, 113 subjects (61%) underwent prehabilitation. Changes in 6MWD in the prehabilitation group were higher compared to the rehabilitation/control group during the preoperative period {30.0 [standard deviation (SD) 46.7] m vs. -5.8 (SD 40.1) m, p < 0.001}, at four weeks [-11.2 (SD 72) m vs. -72.5 (SD 129) m, p < 0.01], and at eight weeks [17.0 (SD 84.0) m vs. -8.8 (SD 74.0) m, p = 0.047]. The proportion of subjects experiencing a significant preoperative improvement in physical fitness was higher in those patients who underwent prehabilitation [68 (60%) vs. 15 (21%), p < 0.001]. CONCLUSION: In large secondary analysis, multimodal prehabilitation resulted in greater improvement in walking capacity throughout the whole perioperative period when compared to rehabilitation started after surgery.

Patients with poor baseline walking capacity are most likely to improve their functional status with multimodal prehabilitation.

BACKGROUND: Evidence suggests that multimodal prehabilitation programs comprising interventions directed at physical activity, nutrition, and anxiety coping can improve functional recovery after colorectal cancer operations; however, such programs may be more clinically meaningful and cost-effective if targeted to specific subgroups. This study aimed to estimate the extent to which patients with poor baseline functional capacity improve their functional capacity. METHODS: Data for 106 participants enrolled in a multimodal, prehabilitation program before colorectal operations were analyzed. Low baseline functional capacity was defined as a 6-minute walking test distance (6MWD) of less than 400 m. Participants were categorized as higher fitness (6MWD ≥ 400 m, n = 70) or lower fitness (6MWD <400 m, n = 36). Changes in 6MWD over the preoperative period, and 4 weeks and 8 weeks after the operation were compared between groups. Secondary outcomes included patient-reported physical activity and health status, postoperative complications, duration of hospital stay, and readmissions. Less-fit patients were then compared with subjects in the rehabilitation arm of the original studies who had a baseline 6MWD <400 m. RESULTS: Participants with lower baseline fitness had greater improvements in functional walking capacity with prehabilitation compared to patients with higher fitness (+46.5 [standard deviation 53.8] m vs +22.6 [standard deviation 41.8] m, P = .012). At 4 weeks postoperatively, patients with lower baseline fitness were more likely to be recovered to their baseline 6MWD than those with higher fitness. (74% vs 50%, P = .029). There were no differences in secondary outcome. Less-fit patients had a greater improvement through all the preoperative period compared to the control group. CONCLUSION: Patients with lower baseline walking capacity are more likely to experience meaningful improvement in physical function from prehabilitation before and after a colorectal cancer operation.