Frail Elderly SyndromePREHABILNCT04461301
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial
A study testing Multimodal Prehabilitation in people with Frail Elderly Syndrome and Major Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Major Surgery
- What is being tested?
- Multimodal Prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 30 Dec 2026
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written informed consent
- comorbid (≥ASA 3)
- pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT unavailable or VE/VCO2 slope > 33
- scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
- screening at least 2 weeks prior to surgery
Who cannot join
- Paralysis or patients with mobility problems (who are unable to exercise),
- Premorbid conditions or orthopaedic impairments that contraindicate exercise,
- Cognitive disabilities,
- Chronic renal failure (need for dialysis)
- Emergency procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Bern, Canton of Bern, 3010
Dominique A Engel, Dr, 00316322111, dominique.engel@insel.ch
Patrick Wuethrich, Prof, 00416322111, patrick.wuethrich@insel.ch
About this study
Official title: Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
Read the detailed description
Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future.
This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT).
The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation.
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients.
The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).
- Conditions
- Frail Elderly Syndrome, Major Surgery
- Being tested
- Multimodal Prehabilitation
- Keywords
- Comprehensive Complication Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationProcedure or surgery
A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist. Receives: Procedure: Multimodal Prehabilitation |
| Control | No intervention | Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index (CCI)
The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
Measured: 30 days after surgery
Secondary outcomes (5)
Cardiovascular & Pulmonary
Cardio-Pulmonary Exercise Test (CPET): Peak VO2, VO2 at VT1, peak VE, VE/VCO2 slope, O pulse, FEV1, FEV1/FVC, resting HR, HR reserve, resting systolic and diastolic BP, CPAx ICUD and CPAX HosD in case of ICU admission, Maximum inspiratory pressure , Grip strength, NTproBNP, serial hsTroponin in case of raised NTproBNP, change in preoperative P-POSSUM score
Measured: Before and after 2-4 weeks of prehabilitation, at 30 days
Nutrition & Bioimpendance
Nutritional Risk Score (NRS), Bio impedance: weight, muscle mass, fat mass, percent body fat, extracellular water/intracellular water, and phase angle, Fat Free Body Mass (FFM) and Lean body Mass (LBM), Days nil per mouth
Measured: At the beginning of study, before and after surgery, at 30 days.
Anaemia
Presence of anaemia, Transfusion rates in the first 30 days after surgery.
Measured: 30 days after surgery
Smoking
Successful smoking cessation rate, Exhaled CO measured.
Measured: At the beginning of study, before and after surgery, at 30 days.
Questionnaires for recovery, anxiety and cardiac risk
Quality of Recovery Score (QoR-15), State-Trait Anxiety Inventory Test (STAI-T), Duke Activity Status Index (DASI)
Measured: At the beginning of study, before and after surgery, at 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Feb 2022
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Department of clinical research, Bern
- Responsible party
- Principal investigator, Dominique Engel, Insel Gruppe AG, University Hospital Bern
- Investigators
- Dominique A Engel, Dr, Principal investigator, Department of Anaesthesiology and Pain Therapy, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461301
- Sponsor's protocol ID
- PREHAB2020
- Acronym
- PREHABIL
- Status last verified
- May 2024
- First submitted
- 2 Jul 2020
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dueblin SW, Wuethrich PY, Engel D, Eser P, Beilstein CM, Wilhelm M, Vetsch T. Inspiratory muscle training as part of multimodal prehabilitation improves maximal inspiratory pressure in elderly surgical patients: an exploratory secondary analysis of a randomised controlled trial. BMC Geriatr. 2026 Jul 7. doi: 10.1186/s12877-026-07944-3. Online ahead of print.
PubMed 42414962Vetsch T, Dueblin SW, Eser P, Beilstein CM, Wuethrich PY, Wilhelm M, Engel D. Effect of multimodal home-based prehabilitation on objectively measured physical activity in patients undergoing elective cardiac or non-cardiac major surgery: secondary outcomes from a randomised controlled trial. Perioper Med (Lond). 2025 Jul 4;14(1):69. doi: 10.1186/s13741-025-00554-4.
PubMed 40615882Beilstein CM, Krutkyte G, Vetsch T, Eser P, Wilhelm M, Stanga Z, Bally L, Verra M, Huber M, Wuethrich PY, Engel D. Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial). BMJ Open. 2023 Jan 3;13(1):e070253. doi: 10.1136/bmjopen-2022-070253.
PubMed 36596634
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).
- ClinicalTrials.gov ID
- NCT04461301
- Acronym / sponsor ID
- PREHABIL / PREHAB2020
- Conditions
- Frail Elderly Syndrome, Major Surgery
- Keywords
- Comprehensive Complication Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Department of clinical research, Bern
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jul 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.
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
Detailed description
Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future.
This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT).
The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation.
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients.
The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel group, multi-centre, multidisciplinary, active controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Multimodal PrehabilitationPatients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist. |
| Control | No intervention | –Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- comorbid (≥ASA 3)
- pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT unavailable or VE/VCO2 slope > 33
- scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
- screening at least 2 weeks prior to surgery
Key exclusion criteria (5 listed)
- Paralysis or patients with mobility problems (who are unable to exercise),
- Premorbid conditions or orthopaedic impairments that contraindicate exercise,
- Cognitive disabilities,
- Chronic renal failure (need for dialysis)
- Emergency procedures.
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 |
|---|---|---|
| Multimodal PrehabilitationA multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation). | Procedure or surgery | Intervention |
Primary outcome
Comprehensive Complication Index (CCI)
Time frame: 30 days after surgery
The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
5 secondary outcomes
Cardiovascular & Pulmonary
Time frame: Before and after 2-4 weeks of prehabilitation, at 30 days
Nutrition & Bioimpendance
Time frame: At the beginning of study, before and after surgery, at 30 days.
Anaemia
Time frame: 30 days after surgery
Smoking
Time frame: At the beginning of study, before and after surgery, at 30 days.
Questionnaires for recovery, anxiety and cardiac risk
Time frame: At the beginning of study, before and after surgery, at 30 days.
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 Nov 2024.
- Derived from this study: PubMed 42414962Dueblin SW, Wuethrich PY, Engel D, Eser P, Beilstein CM, Wilhelm M, Vetsch T. Inspiratory muscle training as part of multimodal prehabilitation improves maximal inspiratory pressure in elderly surgical patients: an exploratory secondary analysis of a randomised controlled trial. BMC Geriatr. 2026 Jul 7. doi: 10.1186/s12877-026-07944-3. Online ahead of print.
- Derived from this study: PubMed 40615882Vetsch T, Dueblin SW, Eser P, Beilstein CM, Wuethrich PY, Wilhelm M, Engel D. Effect of multimodal home-based prehabilitation on objectively measured physical activity in patients undergoing elective cardiac or non-cardiac major surgery: secondary outcomes from a randomised controlled trial. Perioper Med (Lond). 2025 Jul 4;14(1):69. doi: 10.1186/s13741-025-00554-4.
- Derived from this study: PubMed 36596634Beilstein CM, Krutkyte G, Vetsch T, Eser P, Wilhelm M, Stanga Z, Bally L, Verra M, Huber M, Wuethrich PY, Engel D. Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial). BMJ Open. 2023 Jan 3;13(1):e070253. doi: 10.1136/bmjopen-2022-070253.
- 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.
Dominique A Engel, Dr principal investigator
Department of Anaesthesiology and Pain Therapy, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation in people with Frail Elderly Syndrome and Major Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 5 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 Nov 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 Switzerland. 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 Dominique A Engel, Dr (0041316322111, dominique.engel@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (CCI) (time frame: 30 days after surgery). 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 NCT04461301, which also lists 3 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 1 Nov 2024.