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 program prior to robotic-assisted radical prostatectomy (RARC) contributes to a faster recovery of quality of life after surgery.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Radical Prostatectomy
• Intervention / Treatment: Behavioral: Multimodal prehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Eligible patients:

• Men aged ≥18 years
• Histologically confirmed localized or locally advanced prostate cancer - Scheduled for robotic-assisted radical prostatectomy (RARP).

Exclusion criteria:

• Metastatic disease
• Prior treatment for prostate cancer (e.g., brachytherapy, radiotherapy), - Significant cardiopulmonary comorbidities contraindicating physical activity
• Declining consent
• Patients referred from hospitals outside our city were also excluded (to ensure consistent adherence to the prehabilitation program at nearby fitness centers).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients receive standard preoperative instructions, including routine lifestyle counseling consistent with hospital practice.
Experimental: Multimodal prehabilitation; This patients receive the full pre-habilitation program	Behavioral: Multimodal prehabilitation; Patients randomized to the intervention group participated in a structured, four-week multimodal prehabilitation program, initiated immediately after the baseline assessment. The program was delivered by a multidisciplinary prehabilitation team. The program consisted of the following components lead by specialists: Physical activity: aerobic/resistance exercises 45-60min x 2-3 times per week (adapted by a personal trainer), encouraged to walk 7500 steps daily; Pelvic floor muscle training: a structured PFMT program, introduced and supervised by a physiotherapist during baseline assessment and unsupervised with written instructions for home practice; Nutritional optimization: weekly group sessions led by a dietitian and supplementation was tailored to individuals needs.; Psychological Support: weekly 60-minute group sessions based on mindfulness-based stress reduction led by a psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early postoperative HRQoL	The change in the global health status domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	From baseline to 1 month after RARP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional HRQoL domains of the EORTC QLQ-C30	Additional HRQoL domains of the EORTC QLQ-C30	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Mental health	Hospital Anxiety and Depression Scale (HADS)	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Physical performance	6-minute walk test (6MWT)	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Functional recovery	Urinary continence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Erectile Function	Index of Erectile Function-5 (IIEF-5)	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Disease-specific HRQoL	EORTC QLQ-PR25	Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Antoni Vilaseca, Dr, Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prehabilitation; Robotic-assisted radical prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HCB/2021/0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No