Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.
March 26, 2026 updated by: Hospital Clinic of Barcelona
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Catalonia
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Barcelona, Catalonia, Spain, 08036
- Hospital Clinic de Barcelona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Patients receive standard preoperative instructions, including routine lifestyle counseling consistent with hospital practice.
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Experimental: Multimodal prehabilitation
This patients receive the full pre-habilitation program
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early postoperative HRQoL
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)
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From baseline to 1 month after RARP
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Additional HRQoL domains of the EORTC QLQ-C30
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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Additional HRQoL domains of the EORTC QLQ-C30
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Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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Mental health
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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Hospital Anxiety and Depression Scale (HADS)
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Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
|
Physical performance
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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6-minute walk test (6MWT)
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Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
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Functional recovery
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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Urinary continence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
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Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
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Erectile Function
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
Index of Erectile Function-5 (IIEF-5)
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Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
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Disease-specific HRQoL
Time Frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
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EORTC QLQ-PR25
|
Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoni Vilaseca, Dr, Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.