Brief Summary

The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients. The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for not_applicable

Timeline

4mo left

Started Jan 2025

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Progress80%

Jan 2025Sep 2026

First Submitted

Initial submission to the registry

January 17, 2025

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed

7 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

January 17, 2025

Last Update Submit

August 5, 2025

Conditions

Cancer Surgery

Keywords

PrehabilitationFunctional recoveryRelaxationExerciseDietNutritionFunctional walkingHospital stayMultimodal prehabilitation programStandard treatmentAnesthesiology

Outcome Measures

Primary Outcomes (1)

Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification
30 days after surgery

Secondary Outcomes (6)

Time to Functional Recovery (TFR)
30 days after surgery
Lenght of hospital stay (LOS)
30 days after surgery
Days at home up to 30 days after surgery (DAH-30)
30 days after surgery
Complication severity
30 days after surgery
Proportion of patients returning to preoperative functional walking capacity
30 days after surgery
+1 more secondary outcomes

Study Arms (2)

Prehabilitation

EXPERIMENTAL

The prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline. This will be on top of Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery).

Behavioral: Multimodal prehabilitation Program

Control group

NO INTERVENTION

Standard care treatment with application of ERAS pathways (Enhanced Recovery After Surgery)

Interventions

Multimodal prehabilitation ProgramBEHAVIORAL

A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effects. The duration of the program will be set at a minimum of three weeks.

Prehabilitation

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patient (age \> 18 years);
Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
Signed informed consent.

You may not qualify if:

A) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:
Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease);
American Society of Anesthesiologists (ASA) physical status classes 4-5;
Disabling orthopedic and neuromuscular disease;
Psychosis, dementia;
Symptomatic anemia with a hemoglobin value \< 7 gr/dl.
B) Patients with both optimal functional capacity (a Duke activity status index \[DASI\] score \> 45) and optimal nutritional status (NRS-nutrition screening tool-score \< 2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Policlinico Universitario AOU Renato Dulbecco di Catanzaro

Catanzaro, Italy, 88100, Italy

RECRUITING

AOU Careggi

Florence, Italy, 50134, Italy

NOT YET RECRUITING

Ospedale Galliera di Genova

Genova, Italy, 16128, Italy

NOT YET RECRUITING

ASSTN GOM Niguarda

Milan, Italy, 20162, Italy

NOT YET RECRUITING

IRCCS Ospedale San Gerardo dei Tintori

Monza, Italy, 20900, Italy

NOT YET RECRUITING

Ospedale Vanvitelli di Napoli

Napoli, Italy, 80129, Italy

RECRUITING

AOPD Padova

Padua, Italy, 35128, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Friuli Centrale (ASU FC)

Udine, Italy, 33100, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milan, 20132, Italy

RECRUITING

Related Publications (6)

Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.
PMID: 29262307BACKGROUND
Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
PMID: 29452805BACKGROUND
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
PMID: 35588252BACKGROUND
Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
PMID: 23756434BACKGROUND
Lemanne D, Cassileth B, Gubili J. The role of physical activity in cancer prevention, treatment, recovery, and survivorship. Oncology (Williston Park). 2013 Jun;27(6):580-5.
PMID: 23909073BACKGROUND
Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
PMID: 25501695BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

Marina Pieri, Medical Doctor
IRCCS Ospedale San Raffaele
PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina LG Pieri, Medical Doctor

CONTACT

+393334625052 pieri.marina@hsr.it

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Doctor

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

January 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing: Will not share

Locations

IT(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Prehabilitation

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations