Intensive physical therapy after emergency laparotomy: Pilot phase of the Incidence of Complications following Emergency Abdominal surgery Get Exercising randomized controlled trial.

BACKGROUND: Postoperative pneumonia and delayed physical recovery are significant problems after emergency laparotomy. No randomized controlled trial has assessed the feasibility, safety, or effectiveness of intensive postoperative physical therapy in this high-risk acute population. METHODS: The internal pilot phase of the Incidence of Complications after Emergency Abdominal Surgery: Get Exercising (ICEAGE) trial was a prospective, randomized controlled trial that evaluated the feasibility, safety, and clinical trial processes of providing intensive physical therapy immediately following emergency laparotomy. Fifty consecutive patients were recruited at the principal participating hospital and randomly assigned to standard-care or intensive physical therapy of twice daily coached breathing exercises for 2 days and 30 minutes of daily supervised rehabilitation over the first 5 postoperative days. RESULTS: Interventions were provided exactly as per protocol in 35% (78 of 221 patients) of planned treatment sessions. Main barriers to protocol delivery were physical therapist unavailability on weekends (59 of 221 patients [27%]), awaiting patient consent (18 of 99 patients [18%]), and patient fatigue (26 of 221 patients [12%]). Despite inhibitors to treatment delivery, the intervention group still received twice as many breathing exercise sessions and four times the amount of physical therapy over the first 5 postoperative days (23 minutes [interquartile range, 12-29 minutes] vs. 86 minutes [interquartile range, 53-121 minutes]; p < 0.001). One adverse event was reported from 78 rehabilitation sessions (1.3%), which resolved fully on cessation of activity without escalation of medical care. CONCLUSION: Intensive postoperative physical therapy can be delivered safely and successfully to patients in the first week after emergency laparotomy. The ICEAGE trial protocol resulted in intervention group participants receiving more coached breathing exercises and spending significantly more time physically active over the first 5 days after surgery compared with standard care. It was therefore recommended to progress into the multicenter phase of ICEAGE to definitively test the effect of intensive physical therapy to prevent pneumonia and improve physical recovery after emergency laparotomy. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Validity and Utility Testing of a Criteria-led Discharge Checklist to Determine Post-operative Recovery after Abdominal Surgery: an International Multicentre Prospective Cohort Trial.

BACKGROUND: Criteria-led discharge (CLD) has promising potential to reduce unnecessary hospital stay after abdominal surgery; however, the validity and utility of CLD is uncertain as studies are limited to small single-centre studies involving predominantly elective colorectal surgery. METHODS: This prospective international multicentre cohort study explored the relationship between a CLD checklist, post-operative recovery, and hospital length of stay using patient-level data from four clinical trials involving 1071 adults undergoing all types of emergency and elective abdominal surgery at five hospitals across Australia and New Zealand. Patients were assessed daily for 21 post-operative days using a standardised CLD checklist. Surgeons and hospital clinicians were masked to findings. Criterion, construct, and content validity of the checklist to accurately reflect discharge decisions by surgical teams, assess physiological recovery, and encompass parameters signalling physiological readiness to discharge were tested. Potential utility of CLD to minimise unnecessary hospital stay was assessed by comparing day of readiness to discharge to actual day of discharge. RESULTS: The CLD checklist had concordance with existing discharge planning practices and accurately measured a longer post-operative recovery in more complex clinical situations. The CLD checklist in its current format did not detect all legitimate medical and surgical reasons necessitating a continued stay in hospital. Day of readiness to discharge was 0.8 days (95% CI 0.7 to 0.9, p < 0.001) less than actual day of discharge. CONCLUSION: A CLD checklist has excellent criterion and construct validity in measuring physiological recovery following all types of major elective and emergency abdominal surgery. Content validity could be improved. The use of CLD has the potential to reduce unnecessary hospital stay although the safety of discharging patients according to the criteria requires investigation prior to implementation. TRIAL REGISTRATION: Trials were prospectively registered at the Australian New Zealand Clinical Trials Registry (LIPPSMAck POP 12613000664741, ICEAGE 12615000318583, PLASTIC 12619001344189, NIPPER PLUS 12617000269336).

ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery.

Background: Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard care alone. Methods: The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient- and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15 min) or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum 2 days, and 30 min of daily supervised early rehabilitation for minimum five postoperative days). The primary outcome is a respiratory complication within the first 14 postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30 days and at 1 year following surgery. Discussion: The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, minimal harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial. Trial registration: ACTRN 12615000318583. Registered 8 April 2015.

The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial.

OBJECTIVE: To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett's oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development. METHODS: A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions) versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions) in inactive, overweight/obese (25.0-34.9 kg/m2) males with Barrett's oesophagus, aged 18-70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]). Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value. RESULTS: Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80); 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control) was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01). Effects on primary outcomes were not statistically significant. CONCLUSION: This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this population and relax inclusion criteria to maximize recruitment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000401257.

Physical activity and cancer prevention: a systematic review of clinical trials.

BACKGROUND: Physically active individuals have lower rates of many cancers and improved cancer outcomes. Controlled exercise trials measuring putative biomarkers of cancer risk are being conducted to further understand the role of exercise in cancer etiology and progression. We aimed to systematically review the effect of exercise on various biomarkers. METHODS: A comprehensive search strategy identified 353 publications from January 1980 to August 2010. We included those clinical trials of exercise measuring biomarkers following minimum 4-week intervention among cancer survivors or people with one or more cancer risk factors. Two reviewers abstracted data and assessed quality independently. Effect sizes and 95% confidence intervals were estimated. RESULTS: Four primary prevention and five tertiary prevention trials were included. Exercise had a small to moderate effect on improving concentrations of several blood biomarkers implicated in breast and colon cancer pathways including insulin, leptin, estrogens, and apoptosis regulation. In breast cancer survivors, exercise had a small to moderate effect on improving some biomarkers associated with prognosis including various insulin-like growth factor axis proteins, insulin, and inflammation; and a large effect on enhancing immune function. CONCLUSION: Data are few, but there is some evidence to support the role of exercise in modulating various cancer pathways.

Exercise and the Prevention of Oesophageal Cancer (EPOC) study protocol: a randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus.

BACKGROUND: Chronic gastro-oesophageal reflux disease and excessive body fat are considered principal causes of Barrett's oesophagus (a metaplastic change in the cells lining the oesophagus) and its neoplastic progression, oesophageal adenocarcinoma. Metabolic disturbances including altered levels of obesity-related cytokines, chronic inflammation and insulin resistance have also been associated with oesophageal cancer development, especially in males. Physical activity may have the potential to abrogate metabolic disturbances in males with Barrett's oesophagus and elicit beneficial reductions in body fat and gastro-oesophageal reflux symptoms. Thus, exercise may be an effective intervention in reducing oesophageal adenocarcinoma risk. However, to date this hypothesis remains untested.The 'Exercise and the Prevention of Oesophageal Cancer Study' will determine whether 24 weeks of exercise training will lead to alterations in risk factors or biomarkers for oesophageal adenocarcinoma in males with Barrett's oesophagus. Our primary outcomes are serum concentrations of leptin, adiponectin, tumour necrosis factor-alpha, C-reactive protein and interleukin-6 as well as insulin resistance. Body composition, gastro-oesophageal reflux disease symptoms, cardiovascular fitness and muscular strength will also be assessed as secondary outcomes. METHODS/DESIGN: A randomized controlled trial of 80 overweight or obese, inactive males with Barrett's oesophagus will be conducted in Brisbane, Australia. Participants will be randomized to an intervention arm (60 minutes of moderate-intensity aerobic and resistance training, five days per week) or a control arm (45 minutes of stretching, five days per week) for 24 weeks. Primary and secondary endpoints will be measured at baseline (week 0), midpoint (week 12) and at the end of the intervention (week 24). DISCUSSION: Due to the increasing incidence and very high mortality associated with oesophageal adenocarcinoma, interventions effective in preventing the progression of Barrett's oesophagus are urgently needed. We propose that exercise may be successful in reducing oesophageal adenocarcinoma risk. This primary prevention trial will also provide information on whether the protective association between physical activity and cancer is causal. TRIAL REGISTRATION: ACTRN12609000401257.