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

Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.

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.

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.

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.

Change in continence during the prehabilitation program and postoperative recovery. International Consultation on Incontinence Questionnaire (ICIQ) Scoring scale: 0-21 Higher value means worse outcome

Change in perioperative anxiety levels Hospital Anxiety & Depression (HAD ) Scoring scale: 0-21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

6 Minute Walk Test (6MWT) Distance covered over a time of 6 minutes. Higher time means worse physical status.

Yale physical activity survey (YPAS) Part 1 - Scoring scale: 0-85680 kcal/week Part 2 - Scoring scale: 0-142 Part 3 - Scoring scale: 0.7-1.3 Higher values indicates higher activity.

International Index Erectile Function (IIEF-5) Change in erectile function during the prehabilitation program and postoperative recovery. Scoring scale: 5-25 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction

EORTC QLQ - C30 Scoring scale: 0-100 Higher value indicates higher perceived general quality of life

EORTC QLQ - PR25 Scoring scale: 0-100 Higher value indicates higher perceived prostate quality of life

Clavien-Dindo Classification (CDC) Scoring scale: 1-5 Higher value indicates more severe complication

Comprehensive Complications Index (CII) Scoring scale: 0-100 Higher value indicates more severe complication

Usability questionare Includes a combination of the System Usability Scale (SUS) and the Net Promoter Score (NPS). Scoring scale: 0-100 Higher value indicates better perceived usability

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.