Bousquet‐Dion 2018.
Study characteristics | ||
Methods | Design: parallel‐arm single‐blinded, single centre randomised controlled trial. Setting: single tertiary care centre, Montreal, Quebec, Canada. Recruitment: participants were enrolled from December 2013 to August 2015. Consecutive patients scheduled for surgery were approached during the first consult to the surgeon. After consent, participants started with a baseline assessment approximately four weeks before surgery. They were assessed by a nutritionist, kinesiologist and psychology‐trained research team member. By computer‐generated random numbers in sealed envelopes, patients were randomly assigned on a 1:1 ratio to either PREHAB+ or REHAB. Follow‐up: follow‐up was up to eight weeks postoperatively. Surgical care followed ERAS guidelines. Blinding: outcome assessors of the primary outcome were blinded to group assignment. |
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Participants | Screened: 88 patients randomised: 80 patients analysed: 63 patients Inclusion criteria: adult patients with non‐metastatic colorectal cancer resection. Exclusion criteria: patients were ineligible in case of metastases, did not speak French or English, and/or had a contraindication for exercise. Baseline characteristics: median age in PREHAB+ group was 74 and 71 in the REHAB group. The majority was male, had a colonic resection and was operated laparoscopically in both groups. |
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Interventions | The content of the multimodal programme was identical in both groups. However, the timing of the start of the programme differed between groups. PREHAB+ (n = 37): the home‐based programme commenced immediately after baseline assessment. In the pre‐surgical period, patients attended an in‐laboratory exercise session supervised by a kinesiologist. Period between baseline assessment and surgery was approximately four weeks. After surgery, patients resumed the programme, only without the supervised sessions for an additional eight weeks. REHAB (n = 26): patients preoperatively received standard of care according to ERAS guidelines. Two days before surgery, an eight weeks home‐based post‐surgical rehabilitation programme was prescribed to the participants. Exercise Home‐based exercise (both groups): whole body exercise prescription, following the guidelines of the American College of Sports Medicine, individualised to participants' fitness level. The intensity of aerobic exercise was based on rate of perceived exertion (using Borg scale) and the 6MWT results at baseline. Aerobic exercise consisted of walking, cycling or jogging and participants were prescribed to perform 30 minutes of moderate intensity exercise (60‐70% of maximum heart rate calculated with Karvonen formula) three to four days per week. Resistance exercises were based on eight repetitions maximum test. Participants were instructed to perform three to four days per week up to two sets of 8‐15 repetitions of resistance exercise, consisting of eight exercises targeting major core, upper and lower limb muscle groups. Patients were provided with an elastic resistance band. Exercise intensity was evaluated and adjusted using the Borg scale. In‐hospital supervised sessions (PREHAB+): supervised by a kinesiologist patients returned to the hospital once a week to train for 30 minutes on a recumbent stepper or a standard treadmill, and to perform resistance exercises for 25 minutes. In‐hospital exercise (both groups): as soon as they were mobilised, patients were instructed to exercise. The REHAB group was able to review the post‐surgical programme. The PREHAB+ group recommenced the programme. Nutritional intervention A registered dietitian provided nutritional counselling based on the nutritional status as determined with the baseline assessment (SGA, NRS2002, 3‐day food diary, assessment of macronutrient intake and food choices). In case the participants did not meet the protein requirement of 1.2 g/kg of body weight per day (ESPEN guidelines, requirement in surgical patients) by diet alone, whey protein supplements were provided. Patients were instructed to ingest proteins within one hour of the exercise training. Mental intervention A psychology trained member of the research team provided personalised techniques, such as relaxation and breathing exercises, to alleviate anxiety in a 60‐minute session. Patients were asked to perform these techniques two to three times per week, using a compact disc with audio guidance. Furthermore, coping strategies were assessed. Booklet All patients received an information booklet, including a diary to record all activities. Follow‐up Patients were contacted on a weekly basis, by telephone. |
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Outcomes |
Primary Functional walking capacity as determined by the 6MWT at baseline, before surgery, and at four and eight weeks postoperatively. A change of at least 20 metres was considered to be clinically meaningful. The assessor used a standardized protocol and script and was blinded to group assignment. The results of the 6MWT were given in metres (mean, SD) per time point, per group as well as mean change from baseline per time point, per group. The number of patients (n, %) who improved more or less than 20 metres were reported as well. Secondary Energy expenditure was determined using the Community Healthy Activity Model Programme for Seniors (CHAMPS) questionnaire and were interpreted using the recommendations by the American Cancer Society (ACS) guidelines. CHAMPS was measured at baseline, before surgery, and at four and eight weeks postoperatively. The results were given in kcal/kg/week (median, IQR) per time point in both the PREHAB+ and in the REHAB group. Additionally, the number of patients (n, %) was given who met the ACS recommendations. Body composition determined with anthropometric measurements (bioelectrical impedance analysis and grip strength) are assessed at all four time points, however only the baseline results are presented. Psychological status determined with the Hospital Anxiety and Depression Scale (HADS) was assessed at four time points, however, only the baseline result is displayed. Mean compliance with the programme is presented as % since the previous measurement in both groups and is divided into compliance to the exercise and nutritional intervention. Reported postoperative outcomes 30 days after surgery included length of hospital stay, complications, re‐admissions and emergency department visits. Primary length of stay in the hospital and total hospitalisation were presented as median and IQR for both groups. The number of emergency department visits and re‐admissions are presented for both groups. For these outcomes the intention‐to‐treat analysis is displayed as well. Complications are presented as number and percentage of patients having at least one complication within 30 days, the type of complications are specified and the grade of most severe complication is given using the Clavien‐Dindo classification. |
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Notes | Trial registration number: NCT02586701 Funding source: this trial was funded by the Perioperative Programme Charitable Foundation and the Montreal General Hospital Foundation. No conflict of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...by computer‐generated random numbers." Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "sealed envelopes" Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "...indicating that bias in the form of contamination is also possible." Comment: No blinding. The authors discuss possible bias in the form of contamination in the control group; the primary outcome improved before the rehabilitation programme started. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome: 6MWT Quote: "The assessor...was blinded to group assignment" Comment: probably done Secondary outcomes Comment: Insufficient information on secondary outcomes to permit judgement of low or high risk. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: No intention‐to‐treat analysis is performed. Some patients where lost to follow‐up due to complications and are withdrawn from the analysis. Complication rate is one of the outcomes of this article. |
Selective reporting (reporting bias) | High risk | Comment: the study protocol is not available and only the primary outcome is included in the trial registration. |
Other bias | Unclear risk | Comment: there is insufficient information to assess an other potential bias. |