NCT05553327

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

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
• Radical Prostatectomy

Interventions

Type	Name	Description
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: 1. Physical activity: aerobic/resistance exercises 45-60min x 2-3 times per week (adapted by a personal trainer), encouraged to walk 7500 steps daily 2. 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 3. Nutritional optimization: weekly group sessions led by a dietitian and supplementation was tailored to individuals needs. 4. Psychological Support: weekly 60-minute group sessions based on mindfulness-based stress reduction led by a psychologist

Timeline

• Start date: 2022-05-31
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-09-23
• Last updated: 2026-04-01

Locations

1 site across 1 country: Spain