Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care

NCT03347045 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-20

No results posted yet for this study

Summary

Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing physical and mental health. It has been found to successfully improve functional recovery in patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway (ERP). It is unknown whether the same program is effective in patients undergoing a similar surgery for bladder cancer (radical cystectomy).

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.

Conditions

Interventions

COMBINATION_PRODUCT

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.

OTHER

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.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER
  • University of Calgary

    collaborator OTHER
  • Physiotherapy Alberta - College + Association

    collaborator UNKNOWN
  • University of Alberta

    collaborator OTHER
  • Jason Martyn

    lead OTHER

Principal Investigators

  • Jason Martyn, MScPT · Alberta Health services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-01-15
Completion
2019-07-15

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347045 on ClinicalTrials.gov