Bladder Cancer Clinical Trial
Official title:
Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy: Combining Physical Exercise to Stress Reduction Strategies and Nutritional Supplementation
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.
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).
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