Bladder CancerNCT01836978
Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy
A study testing Prehabilitation in people with Bladder Cancer and Entire Ileal Conduit, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer, Entire Ileal Conduit, Urinary Bladder Cancer
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older
- Referred electively for radical resection of a bladder tumor (may or may not receive adjuvant therapy).
Who cannot join
- American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- Severe cardiac abnormalities
- Severe end-stage organ disease such as cardiac failure (New York Heart Association classes I-IV)
- Chronic Obstructive Pulmonary Disease (COPD)
- Hepatic failure (liver enzymes >50% over the normal range)
- Sepsis
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- Morbid obesity (BMI >35)
- Anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
- Poor comprehension of English or French.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study Arms
- 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.
- 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
- 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.
- 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.
- 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).
- Conditions
- Bladder Cancer, Entire Ileal Conduit, Urinary Bladder Cancer
- Being tested
- Prehabilitation
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group will follow standard MUHC clinical guidelines. This group will receive general instructions, by the preoperative clinic nurse, on exercises (breathing, ankle rotation) to be done before and after surgery. They will also be seen by a nutritionist who will provide general counseling for healthy eating. |
| Prehabilitation | Experimental | 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. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walking test (6MWT)
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk
Measured: up to 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, Principal investigator, Perioperative Programme (POP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836978
- Sponsor's protocol ID
- 12-454-SDR
- Status last verified
- Mar 2018
- First submitted
- 9 Apr 2013
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
PubMed 23052535
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy: Combining Physical Exercise to Stress Reduction Strategies and Nutritional Supplementation
- ClinicalTrials.gov ID
- NCT01836978
- Acronym / sponsor ID
- 12-454-SDR
- Conditions
- Bladder Cancer, Entire Ileal Conduit, Urinary Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group will follow standard MUHC clinical guidelines. This group will receive general instructions, by the preoperative clinic nurse, on exercises (breathing, ankle rotation) to be done before and after surgery. They will also be seen by a nutritionist who will provide general counseling for healthy eating. |
| Prehabilitation | Experimental | Other: PrehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 and older
- Referred electively for radical resection of a bladder tumor (may or may not receive adjuvant therapy).
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- Severe cardiac abnormalities
- Severe end-stage organ disease such as cardiac failure (New York Heart Association classes I-IV)
- Chronic Obstructive Pulmonary Disease (COPD)
- Hepatic failure (liver enzymes >50% over the normal range)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationPatients 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. | Other | Prehabilitation |
Primary outcome
Six minute walking test (6MWT)
Time frame: up to 8 weeks after surgery
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Results publication: PubMed 23052535Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Carli, MD principal investigator
Perioperative Programme (POP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Bladder Cancer and Entire Ileal Conduit, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walking test (6MWT) (time frame: up to 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.