Pelvic floor rehabilitation to improve bowel symptoms, pelvic floor function and quality of life among patients with rectal cancer

The pelvic floor intervention for rectal cancer patients will be delivered in two stages: (1) pre-rehabilitation and (2) rehabilitation. There is actual recommendation to provide rehabilitation before surgeries in order to prepare patients to improve their functional outcomes. The content of pre-rehabilitation and rehabilitation will include pelvic floor exercises and other techniques aiming to recover pelvic floor maximal function after the surgery and to avoid low anterior resection syndrome (LARS) symptoms. The pelvic floor intervention, including all stages and techniques, will be provided by a physical therapist with a postgraduation study on pelvic floor treatment with experience in treating rectal cancer patients. This professional will be trained by researchers on the study protocol. The intervention will take place in a private room of Hospital del Salvador. Stage 1: Pelvic Floor Pre-rehabilitation will be delivered in one session of approximately 40 minutes with physiotherapist educating on the correct contraction of pelvic floor, teaching pelvic floor muscle exercises, and performing capacitive and sensory training with rectal balloon. Health education will include: the most adequate positioning to evacuate, self-care strategies such as diet with high fiber and low fat, reduce spicy and stimulating food (artificial sweeteners, tea, cola drinks and chocolates), and bowel habits (possibility to have increased urgency to defecate after meal or physical activities). A booklet was designed for this study with these instructions and exercises will be provided to the patients as well as an audio that will be sent to their cell phones using Whatsapp application. A mobile number with a whatsapp account will be maintained by the pelvic floor therapist to send the audio and contact patients to reinforce instructions to perform PFME at home. Patients will receive a WhatsApp message once a week to remind about the exercises. A closer contact with the therapist may increase patient´s self-efficacy and adherence to the treatment (Sacomori et al, 2015). In addition, patients will receive a diary to register the days when they exercise their pelvic floor in order to check adherence to home-based exercises. Stage 2: Pelvic Floor Rehabilitation will be delivered in 4 sessions of pelvic floor physiotherapy three weeks before stoma removal, three times for week. Although anorectal function, is not being required for fecal elimination in those with stoma, we will perform PFME and sensory and capacitive training in order to retrain this function and prevent leakage. In addition, patients will receive 5-8 sessions of pelvic floor physiotherapy starting aproximatelly two weeks after stoma removal surgery, over up to one month, three times per week, according to patients´ needs. Each session will last approximately 40 minutes. Rehabilitation will start around 6-10 weeks after the surgery, according to physician indication and stoma removal surgery. The rehabilitation intervention will include pelvic floor exercises, electromiographic biofeedback and capacitive and sensory training: - Pelvic floor muscle exercises (PFME) will be performed following the protocol of Bø and colleagues (1999) who instructed participants to perform a daily total of 24 to 36 slow contractions (high-intensity maximal voluntary contraction with a 6 to 8 seconds hold). Each slow contraction will be followed by three to four fast contractions and then 6 seconds of rest. In addition, patients will be encouraged to contract the pelvic floor muscles before situations that increase intra-abdominal pressure, known as the ‘knack’ (Millet et al, 1998). Patients will be instructed to repeat these exercises at home every day after removal of ostomy. - Electromyographic Biofeedback with the equipment Enraf-Nonius Myomed 632X® connected to a large screen for better visualization, following a protocol similar to that used by Kuo et al (2015) in which neuromuscular stimulation of the pelvic floor muscle was performed 2 to 3 times weekly for a total of 12 treatment sessions. We will use a catheter (Anuform) placed into the anal canal for 10 minutes during each treatment session. When the patient could not tolerate the endoanal method we will use external perineal stimulation. The device delivers a square wave, ramp up and down time will be set for 2 seconds, duration of 8 seconds, frequency of 30Hz, on/off time of 1:3, and pulse duration of 300ms. Patients will be instructed to actively contract pelvic floor muscles when the electrical stimulus is on. - Capacitive and sensory training with a balloon probe will follow the protocol of Liang et al (2016): a trained therapist will perform repeated inflations and deflations of a balloon in stepwise increments of 5 mL of air or saline solution. The patients will be asked to recognize the volume that induced the urge to defecate and the maximal tolerable volume they were able to hold. The patients will be taught to contract the sphincter in response to the perception of rectal distention. This training will be performed once a week with a duration of approximately ten minutes. Both groups will receive conventional cancer treatment and surgery following ERAS protocols, including 10 sessions of physical exercise (aerobic with a stationary bike up to 60-70% of the maximal heart rate reserve calculated with Karvonen et al (1957) formula and resistance training). Pre-rehabilitation with physical exercises is recommended by ERAS pathways (Gustafsson et al, 2018). A study showed that men with digestive cancers who have a good cardiorespiratory fitness also present a lower risk of mortality (Peel et al, 2009). In a large secondary analysis with colorectal cancer patients, authors concluded that multimodal pre-rehabilitation (physical exercise, nutrition, and coping strategies for anxiety) resulted in greater improvement in walking capacity throughout the whole perioperative period when compared to rehabilitation started after surgery (Minnella et al, 2017). The pre-rehabilitation with physical exercises will be provided by a physical therapist specialized in cancer rehabilitation and trained by researchers on the study protocol. This treatment will be provided at the Service of Physical Medicine and Rehabilitation of Hospital del Salvador. References: Bø K, Talseth T, Holme I. 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