SurgeryNCT04498208
Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery
A study testing Physical Prehabilitation, Stress Reduction Prehabilitation and Cognitive Prehabilitation in people with Surgery and Immune System and Related Disorders, run by Stanford University at 1 site in United States.
Trial summary
Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Immune System and Related Disorders, Preoperative Care
- What is being tested?
- Physical Prehabilitation, Stress Reduction Prehabilitation and Cognitive Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 21 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult patients (≥ 18 years)
- Competent to provide informed consent
- Undergoing major elective surgery under general anesthesia in ≥14 days from enrollment (abdominal, thoracic, plastic and neurosurgeries).
- Fluent in English
Who cannot join
- Premorbid conditions or orthopedic impairments with contraindications to exercise
- Cognitive disabilities defined as evolutive neurological or neurodegenerative disease
- ASA score 4 or higher or patient under palliative care
- Illiteracy (inability to read the English language).
- Expected length of stay at hospital < 48 hours
- Patient under tutorship or curatorship
- Pregnant or breast-feeding woman
- Absence of informed consent or request to not participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune System Modulation by Enhanced vs Standard Prehabilitation Program in Patients Undergoing Elective Major Surgery - a Prospective Monocentric Randomized Single-blinded Controlled Trial
Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Novel interventions that improve the resolution of pain, minimize opioid exposure, and accelerate functional recovery after surgery are urgently needed.
Multi-modal pre-operative optimization programs (or "prehab") integrating exercise, nutrition, and stress reduction have been shown to safely and effectively improve outcomes after surgery. However, no objective biological markers assess prehab effectiveness and are able to tailor prehab programs to individual patients. Surgery is a profound immunological perturbation, during which a complex network of innate and adaptive immune cells is mobilized to organize the recovery process of wound healing, tissue repair, and pain resolution. As such, the in-depth assessment of a patient's immune system before surgery is a promising approach to tailor prehab programs to modifiable biological markers associated with surgical recovery. The primary goal of this clinical trial is to determine the effect of a personalized prehab program on patients immunological status before surgery.
Read the detailed description
The study design is a prospective monocenter single-blinded randomized controlled trial in patients undergoing elective major abdominal surgery.
- Patients will be recruited during the surgical consultation, at least 14 days prior to surgery. If they choose to enroll, they will undergo randomization on the day of enrollment.
- Prehabilitation (Day 0): personalized or standard prehabilitation program will be proposed to the patients for a period of 2 to 6 weeks. Immunological, nutritional, physical, cognitive, anxiety and quality of life status will be quantified at baseline by previously trained personnel.
- From the beginning (Day 0) to the end of the prehabilitation program (Day 14 to Day 42): every 7 days, a compliance questionnaire will be filled by phone, by a trained member of the research team blinded to the treatment arm of the study
- End of the prehabilitation period (Day 14 to Day 42): Immunological, nutritional, physical, cognitive and anxiety status after prehabilitation will be recorded by a trained member of the research team blinded to the treatment arm of the study.
- Surgery (Day S)
- Post operative period
- From Day S (2 hours after surgery end) to discharge from the hospital, length of stay, pain and adverse clinical events will be measured and recorded.
- Immunological status will be assessed at Day S+1 by blood draw.
- Cognitive function, neuropathic pain and quality of life will be assessed at Day S + 30.
- Conditions
- Surgery, Immune System and Related Disorders, Preoperative Care, Gastrointestinal Disease, Urological Disease, Gynecologic Disease
- Being tested
- Physical Prehabilitation, Stress Reduction Prehabilitation, Cognitive Prehabilitation, Nutrition Prehabilitation
- Keywords
- Personalized program, Physical Activity, Stress-reduction, Cognition, Nutrition, inflammatory, immune response
- Medical subject headings
- Gastrointestinal Diseases, Urologic Diseases, Genital Diseases, Female, Thoracic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical PrehabilitationBehavioural
First, an evaluation of patient's aerobic capacity, functional mobility, functional strength, ambulation, fall risk, and overall mobility will be done by a trained member of the research team. Based on their functional level and preexisting conditions, therapeutic exercises will be recommended to optimize their strength, endurance, flexibility, and functional mobility in preparation for surgery. Decisions about the interventions are based on the assessment, individual patient characteristics, environmental factors, surgical type, and monitoring of the client's response and progress. Weekly sessions are 30-45 minutes long to monitor the client's response and progress their program. Based on their response to exercise (evaluated also by 2 apps: Timed Walk App and Smart Metronome \& Tuner App), re-evaluation via the assessments described above, change their plan of care (alter frequency, resistance, exercises) or discontinuation of treatment could be decided.
Stress Reduction PrehabilitationBehavioural
Participants will have the opportunity to learn techniques for mindfulness that have been established to reduce stress and assist with pain management with a member of the research team. Patients will be offered to listen to audio recording of relaxation sessions. Each session contains a relaxation technique that the patient practices while listening to the recording. Then the technique is used the next as a baseline to introduce a new technique more advanced. For some patients who struggle with the techniques the program will be adapted. Patients will choose 2 or 3 techniques and work on them.
Cognitive PrehabilitationBehavioural
Cognitive prehabilitation will consist on the daily use of Lumosity training program, an already existing free app built to increase memory skills. The program proposed by Lumosity is tailored to each patient. The use of Lumosity will be monitored at each in-person session. Patients will be expected to complete at least three 5-minute sessions of Lumosity training per day.
Nutrition PrehabilitationBehavioural
Nutrition prehabilitation will involve transitioning the patient to the Mediterranean diet with targets regarding hydration and the proportion of fruits, vegetables, whole grains, and healthy fats the patient will consume in a given day. This nutritional program is flexible, and it allows for specific physician and nutritionist-recommended dietary needs to be incorporated. The patient is also given tools to encourage success in healthier eating, including recipes, sample menus, healthy restaurant options, meal kit options, and local CSA box options
| Study group | Role | What they receive |
|---|---|---|
| Personalized prehabilitation | Experimental | Patients will participate in a personalized health optimization program combining one-on-one coaching, tailored to each patient's physical, nutritional, well-being and cognitive status baseline. Prehabilitation will last from a minimum of 14 days to a maximum of 42 days before surgery Receives: Behavioral: Physical Prehabilitation; Behavioral: Stress Reduction Prehabilitation; Behavioral: Cognitive Prehabilitation; Behavioral: Nutrition Prehabilitation |
| Standard prehabilitation | No intervention | Patients in the control group will be provided with standard instructions in a hard-copy form specific to prehabilitation before surgery associating physical, nutritional, stress-reduction and cognitive recommendations without any personalized coaching for at least 14 days prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite immunological score
Composite immunological score containing a combination of blood immune cell frequencies and intracellular signaling responses. This score will be normalized to "baseline" (i.e. before prehabilitation) score for each patient.
Measured: immediately preoperatively
Secondary outcomes (16)
Proportion of compliant patients
Patient's compliance to prehabilitation programs will be evaluated using a modified Rehabilitation Adherence Measure scale, that will be filled by phone every 7 days during the prehabilitation program, i.e. 2 to 6 times by patient. Compliant patient will be defined by a mean score >= 8/10.
Measured: immediately preoperatively
6 Min Walk Test
Changes in physical status will be examined using 6 Min Walk Test. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Timed Up and Go Test
Changes in physical status will be examined using Timed Up and Go Test. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Five Times Sit to Stand Test
Changes in physical status will be examined using Five Times Sit to Stand Test. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Wall Squat Test
Changes in physical status will be examined using Wall Squat Test. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Body Mass Index
Body Mass Index will be recorded. The evaluation should be based on differences between pre- and post prehabilitation performance
Measured: immediately preoperatively
Amsterdam Preoperative Anxiety and Information Scale
Prevalence and global severity of anxiety will be evaluated using the APAIS (Amsterdam Preoperative Anxiety and Information Scale). The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Pain Catastrophizing Scale
Prevalence and global severity of anxiety will be evaluated using the Pain Catastrophizing Scale. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Changes in diet
Mediterranean Diet Score will be collected. The evaluation should be based on differences between pre- and post prehabilitation performance. A high intake of Mediterranean foods: cereals, legumes, fruit, vegetables, fish, Mon-unsaturated fatty acids to Saturated fatty acids (M/S) ratio, and wine were scored positive (1) and a high intake of the non-Mediterranean foods: dairy and meat negative (0). The score ranged from 0 to 9 and the higher the score the better the compliance to a traditional Mediterranean diet.
Measured: immediately preoperatively
Changes in cognitive functions
Cognitive functions will evaluated by the qMCI test. The evaluation should be based on differences between pre- and post prehabilitation performance.
Measured: immediately preoperatively
Incidence of postoperative complications
Postoperative complications will be scored by the Comprehensive Complication Index. The Comprehensive Complication Index (CCI®) is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
Measured: Postoperatively through to 30 days after surgery
Postoperative pain
Pain scores will be assessed daily by the patient-reported Visual Analog Scale. Visual analog scale to assess the perceived stress on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)
Measured: Postoperatively through to 7 days after surgery
Cumulative opioid consumption
Cumulative opioid consumption will be obtained from the patients' charts up to 7 days after surgery or discharge from hospital if earlier.
Measured: Postoperatively through to day 7
Neuropathic pain
Neuropathic pain will be measured by the Patient Reported Outcome Measurement Information System (PROMIS) Neuropathic Pain Quality scale (PROMIS-PQ-Neuro). The questionnaire contains 5 items questions. Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 5 indicates the most pain imaginable. The total score may be up to 25.
Measured: 30 days after surgery
Hospital length of stay
Hospital length of stay assessed from patients' medical administrative data in days
Measured: 30 days after surgery
Changes in quality of life
Quality of life evaluated thanks to the SF-36 scale is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. Results will be normalized on "baseline" (before prehab) scores.
Measured: 30 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 posted4 Aug 2020
- Study start7 Oct 2020
- Primary completion21 Apr 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brice Gaudilliere, Stanford University
- Investigators
- Brice Gaudilliere, MD, PhD, Principal investigator, Stanford UniversityCindy Kin, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498208
- Sponsor's protocol ID
- IRB-57570
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
PubMed 25253674Aghaeepour N, Kin C, Ganio EA, Jensen KP, Gaudilliere DK, Tingle M, Tsai A, Lancero HL, Choisy B, McNeil LS, Okada R, Shelton AA, Nolan GP, Angst MS, Gaudilliere BL. Deep Immune Profiling of an Arginine-Enriched Nutritional Intervention in Patients Undergoing Surgery. J Immunol. 2017 Sep 15;199(6):2171-2180. doi: 10.4049/jimmunol.1700421. Epub 2017 Aug 9.
PubMed 28794234Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific Immune States before Surgery Are Strong Correlates of Surgical Recovery. Anesthesiology. 2015 Dec;123(6):1241-55. doi: 10.1097/ALN.0000000000000887.
PubMed 26655308Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
PubMed 30193337Cambriel A, Tsai A, Choisy B, Sabayev M, Hedou J, Shelton E, Singh K, Amar J, Badea V, Bruckman S, Ganio E, Einhaus J, Feyaerts D, Stelzer I, Sato M, Langeron O, Bonham TA, Gaudilliere D, Shelton A, Kin C, Gaudilliere B, Verdonk F. Immune Modulation by Personalized vs Standard Prehabilitation Before Major Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Jan 1;161(1):20-30. doi: 10.1001/jamasurg.2025.4917.
PubMed 41222945Cambriel A, Tsai A, Choisy B, Sabayev M, Hedou J, Shelton E, Singh K, Amar J, Badea V, Bruckman S, Ganio E, Einhaus J, Feyaerts D, Stelzer I, Sato M, Langeron O, Bonham TA, Gaudilliere D, Shelton A, Kin C, Gaudilliere B, Verdonk F. Immune Modulation by Personalized vs. Standard Prehabilitation Before Major Surgery: A Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 4:2025.06.03.25328894. doi: 10.1101/2025.06.03.25328894.
PubMed 40502574
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune System Modulation by Enhanced vs Standard Prehabilitation Program in Patients Undergoing Elective Major Surgery - a Prospective Monocentric Randomized Single-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT04498208
- Acronym / sponsor ID
- IRB-57570
- Conditions
- Surgery, Immune System and Related Disorders, Preoperative Care, Gastrointestinal Disease, Urological Disease, Gynecologic Disease
- Keywords
- Personalized program, Physical Activity, Stress-reduction, Cognition, Nutrition, inflammatory, immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 4 Aug 2020 (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.
Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Novel interventions that improve the resolution of pain, minimize opioid exposure, and accelerate functional recovery after surgery are urgently needed.
Multi-modal pre-operative optimization programs (or "prehab") integrating exercise, nutrition, and stress reduction have been shown to safely and effectively improve outcomes after surgery. However, no objective biological markers assess prehab effectiveness and are able to tailor prehab programs to individual patients. Surgery is a profound immunological perturbation, during which a complex network of innate and adaptive immune cells is mobilized to organize the recovery process of wound healing, tissue repair, and pain resolution. As such, the in-depth assessment of a patient's immune system before surgery is a promising approach to tailor prehab programs to modifiable biological markers associated with surgical recovery. The primary goal of this clinical trial is to determine the effect of a personalized prehab program on patients immunological status before surgery.
Detailed description
The study design is a prospective monocenter single-blinded randomized controlled trial in patients undergoing elective major abdominal surgery.
- Patients will be recruited during the surgical consultation, at least 14 days prior to surgery. If they choose to enroll, they will undergo randomization on the day of enrollment.
- Prehabilitation (Day 0): personalized or standard prehabilitation program will be proposed to the patients for a period of 2 to 6 weeks. Immunological, nutritional, physical, cognitive, anxiety and quality of life status will be quantified at baseline by previously trained personnel.
- From the beginning (Day 0) to the end of the prehabilitation program (Day 14 to Day 42): every 7 days, a compliance questionnaire will be filled by phone, by a trained member of the research team blinded to the treatment arm of the study
- End of the prehabilitation period (Day 14 to Day 42): Immunological, nutritional, physical, cognitive and anxiety status after prehabilitation will be recorded by a trained member of the research team blinded to the treatment arm of the study.
- Surgery (Day S)
- Post operative period
- From Day S (2 hours after surgery end) to discharge from the hospital, length of stay, pain and adverse clinical events will be measured and recorded.
- Immunological status will be assessed at Day S+1 by blood draw.
- Cognitive function, neuropathic pain and quality of life will be assessed at Day S + 30.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized prehabilitation | Experimental | Behavioral: Physical Prehabilitation, Behavioral: Stress Reduction Prehabilitation, Behavioral: Cognitive Prehabilitation, Behavioral: Nutrition PrehabilitationPatients will participate in a personalized health optimization program combining one-on-one coaching, tailored to each patient's physical, nutritional, well-being and cognitive status baseline. Prehabilitation will last from a minimum of 14 days to a maximum of 42 days before surgery |
| Standard prehabilitation | No intervention | –Patients in the control group will be provided with standard instructions in a hard-copy form specific to prehabilitation before surgery associating physical, nutritional, stress-reduction and cognitive recommendations without any personalized coaching for at least 14 days prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years)
- Competent to provide informed consent
- Undergoing major elective surgery under general anesthesia in ≥14 days from enrollment (abdominal, thoracic, plastic and neurosurgeries).
- Fluent in English
Key exclusion criteria (8 listed)
- Premorbid conditions or orthopedic impairments with contraindications to exercise
- Cognitive disabilities defined as evolutive neurological or neurodegenerative disease
- ASA score 4 or higher or patient under palliative care
- Illiteracy (inability to read the English language).
- Expected length of stay at hospital < 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical PrehabilitationFirst, an evaluation of patient's aerobic capacity, functional mobility, functional strength, ambulation, fall risk, and overall mobility will be done by a trained member of the research team. Based on their functional level and preexisting conditions, therapeutic exercises will be recommended to optimize their strength, endurance, flexibility, and functional mobility in preparation for surgery. Decisions about the interventions are based on the assessment, individual patient characteristics, environmental factors, surgical type, and monitoring of the client's response and progress. Weekly sessions are 30-45 minutes long to monitor the client's response and progress their program. Based on their response to exercise (evaluated also by 2 apps: Timed Walk App and Smart Metronome \& Tuner App), re-evaluation via the assessments described above, change their plan of care (alter frequency, resistance, exercises) or discontinuation of treatment could be decided. | Behavioural | Personalized prehabilitation |
| Stress Reduction PrehabilitationParticipants will have the opportunity to learn techniques for mindfulness that have been established to reduce stress and assist with pain management with a member of the research team. Patients will be offered to listen to audio recording of relaxation sessions. Each session contains a relaxation technique that the patient practices while listening to the recording. Then the technique is used the next as a baseline to introduce a new technique more advanced. For some patients who struggle with the techniques the program will be adapted. Patients will choose 2 or 3 techniques and work on them. | Behavioural | Personalized prehabilitation |
| Cognitive PrehabilitationCognitive prehabilitation will consist on the daily use of Lumosity training program, an already existing free app built to increase memory skills. The program proposed by Lumosity is tailored to each patient. The use of Lumosity will be monitored at each in-person session. Patients will be expected to complete at least three 5-minute sessions of Lumosity training per day. | Behavioural | Personalized prehabilitation |
| Nutrition PrehabilitationNutrition prehabilitation will involve transitioning the patient to the Mediterranean diet with targets regarding hydration and the proportion of fruits, vegetables, whole grains, and healthy fats the patient will consume in a given day. This nutritional program is flexible, and it allows for specific physician and nutritionist-recommended dietary needs to be incorporated. The patient is also given tools to encourage success in healthier eating, including recipes, sample menus, healthy restaurant options, meal kit options, and local CSA box options | Behavioural | Personalized prehabilitation |
Primary outcome
Composite immunological score
Time frame: immediately preoperatively
Composite immunological score containing a combination of blood immune cell frequencies and intracellular signaling responses. This score will be normalized to "baseline" (i.e. before prehabilitation) score for each patient.
16 secondary outcomes
Proportion of compliant patients
Time frame: immediately preoperatively
6 Min Walk Test
Time frame: immediately preoperatively
Timed Up and Go Test
Time frame: immediately preoperatively
Five Times Sit to Stand Test
Time frame: immediately preoperatively
Wall Squat Test
Time frame: immediately preoperatively
Body Mass Index
Time frame: immediately preoperatively
Amsterdam Preoperative Anxiety and Information Scale
Time frame: immediately preoperatively
Pain Catastrophizing Scale
Time frame: immediately preoperatively
Changes in diet
Time frame: immediately preoperatively
Changes in cognitive functions
Time frame: immediately preoperatively
Incidence of postoperative complications
Time frame: Postoperatively through to 30 days after surgery
Postoperative pain
Time frame: Postoperatively through to 7 days after surgery
Cumulative opioid consumption
Time frame: Postoperatively through to day 7
Neuropathic pain
Time frame: 30 days after surgery
Hospital length of stay
Time frame: 30 days after surgery
Changes in quality of life
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 25253674Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
- Background: PubMed 28794234Aghaeepour N, Kin C, Ganio EA, Jensen KP, Gaudilliere DK, Tingle M, Tsai A, Lancero HL, Choisy B, McNeil LS, Okada R, Shelton AA, Nolan GP, Angst MS, Gaudilliere BL. Deep Immune Profiling of an Arginine-Enriched Nutritional Intervention in Patients Undergoing Surgery. J Immunol. 2017 Sep 15;199(6):2171-2180. doi: 10.4049/jimmunol.1700421. Epub 2017 Aug 9.
- Background: PubMed 26655308Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific Immune States before Surgery Are Strong Correlates of Surgical Recovery. Anesthesiology. 2015 Dec;123(6):1241-55. doi: 10.1097/ALN.0000000000000887.
- Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
- Background: PubMed 30193337Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
- Derived from this study: PubMed 41222945Cambriel A, Tsai A, Choisy B, Sabayev M, Hedou J, Shelton E, Singh K, Amar J, Badea V, Bruckman S, Ganio E, Einhaus J, Feyaerts D, Stelzer I, Sato M, Langeron O, Bonham TA, Gaudilliere D, Shelton A, Kin C, Gaudilliere B, Verdonk F. Immune Modulation by Personalized vs Standard Prehabilitation Before Major Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Jan 1;161(1):20-30. doi: 10.1001/jamasurg.2025.4917.
- Derived from this study: PubMed 40502574Cambriel A, Tsai A, Choisy B, Sabayev M, Hedou J, Shelton E, Singh K, Amar J, Badea V, Bruckman S, Ganio E, Einhaus J, Feyaerts D, Stelzer I, Sato M, Langeron O, Bonham TA, Gaudilliere D, Shelton A, Kin C, Gaudilliere B, Verdonk F. Immune Modulation by Personalized vs. Standard Prehabilitation Before Major Surgery: A Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 4:2025.06.03.25328894. doi: 10.1101/2025.06.03.25328894.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brice Gaudilliere, MD, PhD principal investigator
Stanford University
Cindy Kin, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Prehabilitation, Stress Reduction Prehabilitation and Cognitive Prehabilitation in people with Surgery and Immune System and Related Disorders, run by Stanford University at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite immunological score (time frame: immediately preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498208, which also lists 7 linked publications.
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 23 Apr 2024.