Clinical trial NCT05553327: Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.
Official title: Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to verify whether a multimodal prehabilitation programme prior to robotic radical prostatectomy contributes to a faster recovery of quality of life after surgery, to better functional results (including erectile function and continence) and to less perioperative anxiety.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with localized prostate cancer
* Candidates to robotic radical prostatectomy

Exclusion Criteria:

* Non-localized prostate cancer
* Previous history of pelvic radiotherapy or pelvic surgery
* Failure to consent,
* Unwillingness to participate
* Anticipated failure to adhere to the program sessions.

Primary outcomes:
measure: Continence recovery
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Perioperative anxiety levels
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
Secondary outcomes:
measure: Change in physical status by STS
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Change in physical status by 6MWT
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Change in perception of physical status
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Erectile function recovery
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Change in perceived general quality of life
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Change in perceived prostate quality of life
timeFrame: Week 0 and 4 (pre-op); weeks 8, 16 and 28 (post-op)
measure: Early postoperative morbidity by CDC
timeFrame: Week 8 (post-op)
measure: Early postoperative morbidity by CCI
timeFrame: Week 8 (post-op)
measure: Perceived application usability
timeFrame: Week 4
measure: Satisfaction with the multimodal program
timeFrame: Week 4
measure: Nutritional status
timeFrame: Week 0 and 4
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalonia
Study officials:
affiliation: Clinic
name: Antoni Vilaseca, Dr
role: PRINCIPAL_INVESTIGATOR
References: