PrehabilitationPRIME CARENCT07851350
PROPOSAL FOR A PREOPERATIVE FUNCTIONAL OPTIMIZATION PATHWAY FOR PATIENTS CANDIDATE FOR MAJOR SURGERY (CARDIAC AND ABDOMINAL ONCOLOGY)
An observational study of Prehabilitation and Major Abdominal Surgeries, run by ASST Sette Laghi at 2 sites in Italy.
Trial summary
The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Major Abdominal Surgeries, Cardiac Surgery
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 29 Jul 2026to 30 Nov 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.
Who may be able to join
- Elective major abdominal surgery or elective cardio surgery
- American Society of Anaesthesiologists Physical Status Classification ≤ 3
- Performance Status according to ECOG Scale ≤ 2
Who cannot join
- Emergency surgery
- Unstable angina
- Malignant arrythmias
- Severe/ very severe COPD
- Dementia
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Recruiting
Ospedale di Circolo
Varese, VA, 21052
Massimo Stella, MD, +39 0332 393447, maxstella95@gmail.com
- Active, not recruiting
ASST Sette Laghi
Varese, 21100
About this study
Official title: PRehabilitation With Integrated and Multimodal Evaluation in Cardiac and Abdominal majoR surgEry (PRIME CARE) A Proposed Pathway for Preoperative Functional Optimization in Candidates for Major Surgery
The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.
The study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.
This program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.
- Conditions
- Prehabilitation, Major Abdominal Surgeries, Cardiac Surgery, Multimodal and Integrated Program, Major Surgery in Adult Patients
- Keywords
- Prehabilitation, Multimodal and Integrated program, Cardiac surgery, Abdominal Oncology Surgery, Major surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients for major surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
10% improvement from baseline at 6-minutes-walking-test-distance
The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment.
Measured: From enrollment to the date of surgery
Secondary outcomes (12)
Increased thickness of the quadriceps femoris muscle
An increase in the thickness of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres
Measured: From enrollment to the date of surgery
Increased cross-sectional area of the quadriceps femoris muscle
An increase in the cross-sectional area of the quadriceps femoris muscle will be assessed via ultrasound as a direct sign of an increase in the number and volume of muscle fibres
Measured: From enrollment to the date of surgery
Increased pennation angle of the quadriceps femoris muscle
An increase in the pennation angle of the quadriceps femoris muscle, assessed by ultrasound, is a direct sign of increased contractility of the muscle itself, and therefore an indirect index of an increase in muscle strength.
Measured: From enrollment to the date of surgery
Change in Pulmonary Function Parameters
Change in pulmonary volumes including Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and Tiffeneau Index (FEV1/FVC ratio) measured through spirometry at baseline and after completion of prehabilitation.
Measured: From enrollment to the date of surgery
Improvement in Functional Performance Tests
Change in performance at Handgrip Strength test (Newton), and Maximal Isometric Strength test (Newton), assessed at baseline and after the prehabilitation program. An increase in the value indicates an improvement in functional capacity.
Measured: From enrollment to the date of surgery
Change in Diaphragmatic Excursion
Variation in diaphragmatic movement amplitude assessed by ultrasound before and after the prehabilitation period.
Measured: From enrollment to the date of surgery
Change in Health-Related Quality of Life (EQ-5D-5L Index)
Variation in patient-reported quality of life as assessed by the EQ-5D-5L questionnaire. The index score will be compared between baseline and preoperative assessment after prehabilitation and also at 30 days and 180days after discharge
Measured: From enrollment to 180 days after discharge
Incidence of Postoperative Delirium in the Intensive Care Unit
Occurrence of postoperative delirium evaluated daily during ICU stay using the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Perioperative/Periprocedural
Change in Nutritional and Biochemical Markers
Variation in nutritional status indicators assessed through blood biochemical parameters (albumin, prealbumin, total protein, lymphocyte count, iron, transferrin, vitamin B12, folic acid, hemoglobin,) before the prehabilitation program, after the prehabilitation program and at 30 days after discharge
Measured: From enrollment to 30 days after discharge
Length of Stay in Intensive Care Unit
Duration of ICU stay (in days) from postoperative admission to ICU discharge.
Measured: Perioperative/Periprocedural
Total Hospital Length of Stay
Total duration of hospitalization (in days) from admission for surgery to hospital discharge.
Measured: Perioperative/Periprocedural
180-Day Mortality
All-cause mortality evaluated at 180 days after surgery.
Measured: From discharge to 180 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start29 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- ASST Sette Laghi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Guzzetti, Ospedale di Circolo - Fondazione Macchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851350
- Sponsor's protocol ID
- 25/2025
- Acronym
- PRIME CARE
- Status last verified
- Sep 2025
- First submitted
- 18 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRehabilitation With Integrated and Multimodal Evaluation in Cardiac and Abdominal majoR surgEry (PRIME CARE) A Proposed Pathway for Preoperative Functional Optimization in Candidates for Major Surgery
- ClinicalTrials.gov ID
- NCT07851350
- Acronym / sponsor ID
- PRIME CARE / 25/2025
- Conditions
- Prehabilitation, Major Abdominal Surgeries, Cardiac Surgery, Multimodal and Integrated Program, Major Surgery in Adult Patients
- Keywords
- Prehabilitation, Multimodal and Integrated program, Cardiac surgery, Abdominal Oncology Surgery, Major surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ASST Sette LaghiUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate a prehabilitation protocol for patients undergoing cardiac and abdominal surgery. The project for a preparation program for cardiac surgery was developed within the framework of ERAS (Enhanced Recovery After Surgery), which aims to ensure optimal recovery after surgery and a Surgery), which aims to ensure optimal recovery after surgery and an early and safe return to daily activities.
The study focuses on the preoperative phase, with the introduction of the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery. The study focuses on the preoperative phase, introducing the concept of prehabilitation, i.e., a program to enhance the functional abilities of individuals in preparation for major surgery, such as cardiac surgery, on an elective basis.
This program, which currently represents best clinical practice, lasts four weeks and addresses several areas: strengthening respiratory and muscular functions, optimizing nutrition, and cognitive stimulation. Patients will be assessed at enrollment and up to 180 days post-surgery to evaluate their clinical status compared to pre-surgery on these four aspects mentioned above.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients for major surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, observational, single-center study will enroll approximately 50 adult patients (≥18 years old) undergoing elective cardiac or major abdominal surgery at Ospedale di Circolo e Fondazione Macchi, Varese, Italy. Eligible patients for abdominal surgery must have ASA I-III and PS ECOG ≤2. Key exclusion criteria include emergency surgery, unstable angina, malignant arrhythmias, severe or very severe COPD, dementia, pregnancy, or inability to provide informed consent. Participants will be screened by the surgical team and followed during a personalized prehabilitation program starting about one month before surgery.
Key inclusion criteria (3 listed)
- Elective major abdominal surgery or elective cardio surgery
- American Society of Anaesthesiologists Physical Status Classification ≤ 3
- Performance Status according to ECOG Scale ≤ 2
Key exclusion criteria (7 listed)
- Emergency surgery
- Unstable angina
- Malignant arrythmias
- Severe/ very severe COPD
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
10% improvement from baseline at 6-minutes-walking-test-distance
Time frame: From enrollment to the date of surgery
The primary outcome of this study is to evaluate whether prehabilitation translates into an improvement in quality of life before surgery, assessed in terms of functional status. This objective is assessed using the 6-minute walking distance test. A significant improvement is considered to be a positive delta in the six-minute walking test of ≥10% obtained at the assessment performed on the day of admission compared to the value recorded during the first assessment.
12 secondary outcomes
Increased thickness of the quadriceps femoris muscle
Time frame: From enrollment to the date of surgery
Increased cross-sectional area of the quadriceps femoris muscle
Time frame: From enrollment to the date of surgery
Increased pennation angle of the quadriceps femoris muscle
Time frame: From enrollment to the date of surgery
Change in Pulmonary Function Parameters
Time frame: From enrollment to the date of surgery
Improvement in Functional Performance Tests
Time frame: From enrollment to the date of surgery
Change in Diaphragmatic Excursion
Time frame: From enrollment to the date of surgery
Change in Health-Related Quality of Life (EQ-5D-5L Index)
Time frame: From enrollment to 180 days after discharge
Incidence of Postoperative Delirium in the Intensive Care Unit
Time frame: Perioperative/Periprocedural
Change in Nutritional and Biochemical Markers
Time frame: From enrollment to 30 days after discharge
Length of Stay in Intensive Care Unit
Time frame: Perioperative/Periprocedural
Total Hospital Length of Stay
Time frame: Perioperative/Periprocedural
180-Day Mortality
Time frame: From discharge to 180 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prehabilitation and Major Abdominal Surgeries, run by ASST Sette Laghi at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Stella, MD (0039 0332393447, maxstella95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10% improvement from baseline at 6-minutes-walking-test-distance (time frame: From enrollment to the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.