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Completed

NCT Number: NCT05553327

Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.

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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Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multimodal prehabilitation

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Additional HRQoL domains of the 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

  2. Mental health

    Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

    Hospital Anxiety and Depression Scale (HADS)

  3. Physical performance

    Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

    6-minute walk test (6MWT)

  4. Functional recovery

    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)

  5. Erectile Function

    Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

    Index of Erectile Function-5 (IIEF-5)

  6. Disease-specific HRQoL

    Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

    EORTC QLQ-PR25

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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