Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: Multimodal prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05553327

HCB/2021/0289

Details and patient eligibility

About

The aim of the study is to verify whether a multimodal prehabilitation programme prior to robotic radical prostatectomy contributes to a faster recovery of quality of life after surgery, to better functional results (including erectile function and continence) and to less perioperative anxiety.

Full description

Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic de Barcelona. Patients will be randomized into two groups, one receiving multimodal prehabilitation and the other a control group. Multimodal prehabilitation consists of improving the functional and mental capacity of an individual to cope with a significant stressor, in this case surgery. The design of our prehabilitation program, lasting 4 weeks prior to surgery, consists of three parts; physical state, nutritional state and mental health. In the case of physical condition, a series of supervised and "home-based" exercises (aerobic and functional) will be carried out in addition to specific pelvic floor exercises. The nutritional status will be evaluated by a nutritionist. Diet guidelines will be given and if there are deficiencies they will be supplemented. Regarding mental health, a visit will be made with a psychologist and group and online therapies will be offered. The outcomes will be evaluated before starting the prehabilitation program, at the end of it (just before surgery) and at 4, 8 and 16 weeks after surgery. The outcomes include variables on physical, nutritional and mental state, health-related quality of life (HRQoL), and continence and erectile function.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with localized prostate cancer
• Candidates to robotic radical prostatectomy

Exclusion criteria

• Non-localized prostate cancer
• Previous history of pelvic radiotherapy or pelvic surgery
• Failure to consent,
• Unwillingness to participate
• Anticipated failure to adhere to the program sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

This group of patients will not receive a pre-hab program

Multimodal prehabilitation

Experimental group

Description:

This patients will receive the pre-hab program

Treatment:

Behavioral: Multimodal prehabilitation