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
Verified date | March 2018 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Aged 18 and older - Referred electively for radical resection of a bladder tumor (may or may not receive adjuvant therapy). Exclusion Criteria: - 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 - Morbid obesity (BMI >35) - Anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L) - Poor comprehension of English or French. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 8 weeks after surgery |
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