Prehabilitation to Enhance Postoperative Functional Capacity Following Radical Cystectomy

NCT01836978 | Completed

• 1 other identifier: 12-454-SDR
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Entire Ileal Conduit; Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: Prehabilitation

Interventions

Prehabilitation OTHER

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and older
• Referred electively for radical resection of a bladder tumor (may or may not receive adjuvant therapy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 23052535 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Franco Carli, MD

  Perioperative Programme (POP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPhil

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 22, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

CA (1)