Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy
Condition: Bladder Cancer; Entire Ileal Conduit; Urinary Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The process of enhancing the functional capacity of an individual before an operation to
      enable him or her to withstand the stress of surgery has been termed prehabilitation. It has
      been shown that poor baseline capacity for physical performance and poor nutritional status
      increase the risk of complications after major non cardiac surgery and prolong recovery. A
      controlled randomized study in patients undergoing radical cystectomy for cancer is therefore
      proposed to determine the impact of multimodal prehabilitation on functional exercise
      capacity and functional recovery. Patients who accept to be enrolled in the study will be
      randomized to either a group receiving a multimodal intervention which includes nutritional
      supplementation (Immunocal® whey protein) combined with a physical exercise program and
      stress reduction strategies before and after surgery, or a control group who will receive
      standard preoperative treatment as per our institution.
    

Detailed description: 
      Study Arms

        1. Standard group Patients in this group will follow standard MUHC clinical guidelines.
           This group will receive general instructions on exercises (breathing, ankle rotation) to
           be done before and after surgery by the preoperative clinic nurse. They will also be
           seen by a nutritionist who will provide general counseling for healthy eating.

        2. Prehabilitation group Patients in this group will follow the multimodal protocol
           consisting of nutritional supplementation, a specific physical exercise program and
           stress reduction strategies.

      Randomization Patients will be assigned to the two groups using a computer-generated
      randomization process whereby brown sealed envelopes will be prepared and opened after
      patients' consent has been signed.

      Components of prehabilitation

        1. Nutritional supplementation The nutritional status of patients affected by bladder
           cancer is directly influenced by the presence of cancer which has an impact on all
           aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin)
           metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the
           disease. In addition, a patient who is undernourished before surgery has greater risk of
           morbidity and mortality. The primary goal of nutrition therapy during the perioperative
           period is thus to optimize nutrient stores pre-operatively and provide adequate
           nutrition to compensate for the catabolic response of surgery postoperatively. This
           includes preventing the loss of lean body mass which is inversely correlated with the
           survival of critically ill patients.

           The patients' nutritional status and adequacy of dietary intake will be assessed by a
           nutritionist using a three day food record and the Subjective Global Assessment tool.
           Percentage of lean body mass and fat will be measured with bioelectrical impedance.
           Serum albumin will also be measured. All patients in the prehabilitation group will be
           provided with a whey protein supplement (Immunocal®, Immunotec Inc.) and will be
           provided with strategies to optimize dietary energy and protein intake. The quantity of
           supplement the patient will be required to consume daily will depend on the estimated
           deficit in dietary protein intake. This will be determined based on the difference
           between usual protein intake and protein requirement, as assessed by the nutritionist at
           the baseline assessment. Patients in the control group will receive general instructions
           about healthy eating.

           Compliance will be monitored weekly through phone calls by the study coordinator. The
           patients will also be asked to complete a journal detailing the quantity of nutritional
           supplement consumed each day.

        2. Physical exercise program It has been shown that prehabilitation can improve
           postoperative physical function in cancer patients undergoing colorectal surgery and
           lung resection, and these changes are associated with improvements in mental health,
           vitality, and self-perceived health. Moreover, it appears that subjects whose fitness
           deteriorated preoperatively have more surgical complications and require intensive care.
           A recently published systematic review of preoperative physical exercise by Valkenet et
           al reported less postoperative complications and shorter length of stay in abdominal
           surgery patients. Although the role of exercise intensity is unclear, it appears that
           moderate exercise, carried out in a combination of aerobic and resistance training
           components, is sufficient to build adequate physiological reserve and energy, even in
           patients who receive chemotherapy.

      The exercise component will consist of approximately 60 min of resistance and aerobic
      training, for a minimum of 3 days per week. The exercise program will be individualized based
      upon the baseline fitness test (according to the American College of Sport Medicine, ACMS,
      standard) and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at
      30- 40 % of heart rate reserve, HRR), and 25 min of resistance training (8 exercises
      targeting major muscle groups performed at moderate intensity), and a 5-10 min cool-down and
      stretching period. All exercises will be clearly explained and demonstrated by the
      kinesiologist at baseline. Patients will be asked to carry out this program at home,
      unsupervised, but will be monitored with weekly telephone calls. Training intensity
      progression will occur when the participant can complete aerobic exercise on mild exertion
      and/or when the participant can complete 15 repetitions of a given resistance exercise.
      Participants will be provided with resistance bands and an exercise mat, as well as a
      pedometer and a heart rate monitor, which can be used by the participant to monitor progress
      and by the kinesiologist to monitor daily compliance. A log book will also be completed to
      report all activities and frequency of exercises completed.

      The kinesiologist will follow all the participants on a weekly basis to ensure program
      compliance and address any barriers that may prevent ongoing participation.

      The control group will receive general instructions on how to exercise during hospital stay
      while in bed, walking and sitting.

      C. Anxiety reduction strategy.

      It is expected that patients undergoing bladder surgery for cancer are anxious and depressed.
      The control group will receive general instructions in the preoperative clinic about the
      perioperative care and breathing exercises, while those in the prehabilitation group will be
      seen by a psychologist coordinator who will provide different strategies to deal with anxiety
      and depression (guided imagery, relaxation, visualization, yoga).
    

Intervention name(s): Prehabilitation
Intervention type(s): Other
Intervention description(s): Patients in this group will follow the multimodal protocol consisting of nutritional counseling with Immunocal® whey protein supplementation, an individualized physical exercise program and stress reduction strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care