Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036, Spain
NCT Number: NCT05553327
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.
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Notify Me18 year–99 year
Male
Interventional
Not applicable
Barcelona, Catalonia, 08036, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Eligible patients:
Exclusion criteria
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:
Time frame: From baseline to 1 month after RARP
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: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Additional HRQoL domains of the EORTC QLQ-C30
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
6-minute walk test (6MWT)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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
Index of Erectile Function-5 (IIEF-5)
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
EORTC QLQ-PR25
Hospital Clinic of Barcelona
Other
Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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