Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care
NCT ID: NCT03347045
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-01-15
2019-07-15
Brief Summary
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Objective: To evaluate the appropriateness of a standardized prehabilitation program for implementation into an enhanced recovery pathway for cystectomy patients and determine whether prehabilitation facilitates earlier recovery of functional capacity.
Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.
Design: Participants will follow an 8-week trimodal prehabilitation program consisting of exercise therapy combined with nutritional counseling, protein supplementation, and psychological care; they will be compared to a cohort of participants following ERP care alone.
Conclusion: The proposal will provide insight into the feasibility and effectiveness of trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved clinical outcomes and reduced morbidity.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Trimodal Prehab & ERP
Trimodal prehab includes:
1. Guided exercise program at Repsol Place in Calgary, Alberta 2x/week, hosted by the Total Cardiology group. Home-exercise program for another 3x/week.
2. Nutritional optimization with a high-protein oral supplement, along with nutritional counseling and access to a Registered Dietitian on site.
3. Anxiety reduction workshop and take-home anxiety reduction program.
Trimodal Prehab & ERP
1-hr daily exercise will be completed a total of 5d/week, of which 2 of these sessions are completed through a community fitness center. Following these sessions, the participant will consume a high-protein oral supplement.
Additionally, during the program, participants will be given the option of attending a stress-reduction group and will receive a take-home anxiety-reduction program. They will have access to a physiotherapist, kinesiologist, registered dietitian, and physician throughout the program.
The total length of this program is 8-weeks and is timed to occur in the waiting period between the consent for surgery and operation date.
No Prehab; ERP Alone
The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.
No Prehab; ERP Alone
1-hr daily exercise with a self-completed home-exercise program. The participant will be given nutritional education material and a take-home anxiety-reduction program. They will be responsible for maintaining a journal of their activity.
Interventions
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Trimodal Prehab & ERP
1-hr daily exercise will be completed a total of 5d/week, of which 2 of these sessions are completed through a community fitness center. Following these sessions, the participant will consume a high-protein oral supplement.
Additionally, during the program, participants will be given the option of attending a stress-reduction group and will receive a take-home anxiety-reduction program. They will have access to a physiotherapist, kinesiologist, registered dietitian, and physician throughout the program.
The total length of this program is 8-weeks and is timed to occur in the waiting period between the consent for surgery and operation date.
No Prehab; ERP Alone
1-hr daily exercise with a self-completed home-exercise program. The participant will be given nutritional education material and a take-home anxiety-reduction program. They will be responsible for maintaining a journal of their activity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
3. May or may not receive adjuvant therapy.
4. Written informed consent obtained from subject
Exclusion Criteria
1. American Society of Anesthesiologists (ASA) health class status 4-5;
2. Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
3. Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
2. Undergoing radical cystectomy for a reason other than bladder cancer.
3. Poor comprehension of English or French
4. Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.
18 Years
ALL
No
Sponsors
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Alberta Health services
OTHER
University of Calgary
OTHER
Physiotherapy Alberta - College + Association
UNKNOWN
University of Alberta
OTHER
Jason Martyn
OTHER
Responsible Party
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Jason Martyn
Physiotherapist
Principal Investigators
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Jason Martyn, MScPT
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Central Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2017CRIF-JMARTYN
Identifier Type: -
Identifier Source: org_study_id