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Trial Title:
Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.
NCT ID:
NCT05553327
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal prehabilitation
Description:
- 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.
Arm group label:
Multimodal prehabilitation
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Antoni Vilaseca, Dr
Phone:
932275400
Phone ext:
5545
Email:
avilasec@clinic.cat
Investigator:
Last name:
Antoni Vilaseca, Dr
Email:
Principal Investigator
Investigator:
Last name:
Enric Carbonell, Dr
Email:
Sub-Investigator
Investigator:
Last name:
Claudia Mercader, Dr
Email:
Sub-Investigator
Start date:
May 31, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Source:
Hospital Clinic of Barcelona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05553327
