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

NCT ID: NCT05553327

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-09-01

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multimodal prehabilitation

This patients will receive the pre-hab program

Group Type: EXPERIMENTAL

Multimodal prehabilitation

Intervention Type: BEHAVIORAL

• Physical state: individualised physical status will be evaluated by a physiotherapist. A specific training program and pelvic floor exercises sessions will be led by a physiotherapist.
• Nutritional state: individual nutritional status will be evaluated by a nutritionist and intervention will be done if applicable. A nutrition group session will be held.
• Mental health: mindfulness group sessions led by psychologists will be held.

Interventions

Multimodal prehabilitation

• Physical state: individualised physical status will be evaluated by a physiotherapist. A specific training program and pelvic floor exercises sessions will be led by a physiotherapist.
• Nutritional state: individual nutritional status will be evaluated by a nutritionist and intervention will be done if applicable. A nutrition group session will be held.
• Mental health: mindfulness group sessions led by psychologists will be held.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoni Vilaseca, Dr

Role: PRINCIPAL_INVESTIGATOR

Clinic

Locations

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Antoni Vilaseca, Dr

Role: CONTACT

avilasec@clinic.cat

932 275 400 ext. 5545

Facility Contacts

Antoni Vilaseca, Dr

Role: primary

avilasec@clinic.cat

932275400 ext. 5545

Other Identifiers

HCB/2021/0289

Identifier Type: -

Identifier Source: org_study_id