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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
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)
Time frame: From baseline to 1 month after RARP
Additional HRQoL domains of the EORTC QLQ-C30
Additional HRQoL domains of the EORTC QLQ-C30
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Mental health
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Physical performance
6-minute walk test (6MWT)
Time frame: 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)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Erectile Function
Index of Erectile Function-5 (IIEF-5)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Disease-specific HRQoL
EORTC QLQ-PR25
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.