PrehabilitationPISONCT02953119
Prehabilitation for Elective Major Abdominal Surgery
A study testing Prehabilitation in people with Prehabilitation, run by Nicolas DEMARTINES at 1 site in Switzerland.
Trial summary
Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehabilitation
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Apr 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective major abdominal surgery:
- Esophagus, stomach
- Liver, pancreas
- Small intestine, colon, rectum
- Benign or malignant disease
- Other intra-abdominal open or laparoscopic surgery lasting> 2 hours
- Delay of 3 weeks between consultation and surgery
Who cannot join
- Patient < 18 years, consent not obtained
- Coronary artery disease (≥ stage III according to CCS)
- Heart disease (≥ stage III according to NYHA)
- Uncontrolled cardiac arrhythmias
- COPD (GOLD stage ≥ III)
- Physical inability to ride a bike
- Orthopedic surgery in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital Center
Lausanne, 1011
About this study
Official title: Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
Read the detailed description
Major abdominal surgery is a great stressor to patients and causes large physiological changes, leads to tissue trauma, immobility, psychological distress and reduced quality of life. Physical capacity appears to be an important predictor for postoperative recovery after major abdominal surgery. Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. More specifically prior to major abdominal surgery, preoperative exercise therapy is associated with improved physical fitness of patients, but whether or not this results in fewer complications or faster convalescence remains unclear.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
- Conditions
- Prehabilitation
- Being tested
- Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | The patients will undergo an exercise test on a cycle ergometer (VO2 max), a grip strength test (Jamar dynamometer), a Time Up and Go (TUG) test and a 6 Minutes Walking Test (6-MWT), before and after prehabilitation. Intervention involves 3 training sessions per week during 3 weeks preoperatively, according to the high intensity interval training model, wich consists of:
* 5 minute warm-up (50% of Cardiopulmonary exercise testing, CPET)
* Two 10 minute series of 15 sec sprint intervals (100%) interspersed by 15 sec pauses and a 4 min rest between the two series
* Cool down with a 5 min active recovery period (30%) The grip strength test (Jamar dynamometer), TUG-test and 6-MWT will be repeated between 4 and 6 weeks and 8 and 10 week postoperatively. Receives: Other: Prehabilitation |
| Controls | No intervention | The patients will also undergo an exercise test on a cycle ergometer, a grip strength test (Jamar dynamometer), a TUG-test and a 6-MWT, but only once preoperatively, and between 4 and 6 weeks and 8 and 10 week postoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Comprehensive Complication Index (CCI)
Measured: Up to 30 postoperative days
Secondary outcomes (10)
Postoperative most severe complication
Clavien classification
Measured: Up to 30 postoperative days
Length of stay
From the day of hospitalization to the exit
Measured: Up to 30 postoperative days
Readmission rates
Any readmission to the hospital
Measured: Up to 30 postoperative days
Exercise capacity
Exercise testing on a cycloergometer(VO2 max)
Measured: At 3 and 1 week preoperatively
Life satisfaction
Specific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer)
Measured: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Biological inflammatory response
C-reactiv protein (CRP) measure
Measured: Up to 3 postoperative days
Exercise capacity
Time up and go test
Measured: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Walking capacity
6 minutes Walking Test
Measured: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Happiness
Specific questionnaire (EMMBEP questionnaire)
Measured: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Nutritional response
Albumin measure
Measured: Up to 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas DEMARTINES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Martin Hübner, Principal investigator, University Hospital CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953119
- Sponsor's protocol ID
- 469/15
- Acronym
- PISO
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2016
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Michel A, Gremeaux V, Muff G, Pache B, Geinoz S, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M, Martin D, Besson C. Short term high-intensity interval training in patients scheduled for major abdominal surgery increases aerobic fitness. BMC Sports Sci Med Rehabil. 2022 Apr 7;14(1):61. doi: 10.1186/s13102-022-00454-w.
PubMed 35392968
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02953119
- Acronym / sponsor ID
- PISO / 469/15
- Conditions
- Prehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nicolas DEMARTINESUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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.
Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
Detailed description
Major abdominal surgery is a great stressor to patients and causes large physiological changes, leads to tissue trauma, immobility, psychological distress and reduced quality of life. Physical capacity appears to be an important predictor for postoperative recovery after major abdominal surgery. Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. More specifically prior to major abdominal surgery, preoperative exercise therapy is associated with improved physical fitness of patients, but whether or not this results in fewer complications or faster convalescence remains unclear.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: PrehabilitationThe patients will undergo an exercise test on a cycle ergometer (VO2 max), a grip strength test (Jamar dynamometer), a Time Up and Go (TUG) test and a 6 Minutes Walking Test (6-MWT), before and after prehabilitation. Intervention involves 3 training sessions per week during 3 weeks preoperatively, according to the high intensity interval training model, wich consists of: * 5 minute warm-up (50% of Cardiopulmonary exercise testing, CPET) * Two 10 minute series of 15 sec sprint intervals (100%) interspersed by 15 sec pauses and a 4 min rest between the two series * Cool down with a 5 min active recovery period (30%) The grip strength test (Jamar dynamometer), TUG-test and 6-MWT will be repeated between 4 and 6 weeks and 8 and 10 week postoperatively. |
| Controls | No intervention | –The patients will also undergo an exercise test on a cycle ergometer, a grip strength test (Jamar dynamometer), a TUG-test and a 6-MWT, but only once preoperatively, and between 4 and 6 weeks and 8 and 10 week postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Esophagus, stomach
- Liver, pancreas
- Small intestine, colon, rectum
- Benign or malignant disease
- Other intra-abdominal open or laparoscopic surgery lasting> 2 hours
Key exclusion criteria (7 listed)
- Patient < 18 years, consent not obtained
- Coronary artery disease (≥ stage III according to CCS)
- Heart disease (≥ stage III according to NYHA)
- Uncontrolled cardiac arrhythmias
- COPD (GOLD stage ≥ III)
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 |
|---|---|---|
| Prehabilitation | Other | Prehabilitation |
Primary outcome
Postoperative morbidity
Time frame: Up to 30 postoperative days
Comprehensive Complication Index (CCI)
10 secondary outcomes
Postoperative most severe complication
Time frame: Up to 30 postoperative days
Length of stay
Time frame: Up to 30 postoperative days
Readmission rates
Time frame: Up to 30 postoperative days
Exercise capacity
Time frame: At 3 and 1 week preoperatively
Life satisfaction
Time frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Biological inflammatory response
Time frame: Up to 3 postoperative days
Exercise capacity
Time frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Walking capacity
Time frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Happiness
Time frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Nutritional response
Time frame: Up to 3 postoperative days
Results and safety
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 35392968Michel A, Gremeaux V, Muff G, Pache B, Geinoz S, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M, Martin D, Besson C. Short term high-intensity interval training in patients scheduled for major abdominal surgery increases aerobic fitness. BMC Sports Sci Med Rehabil. 2022 Apr 7;14(1):61. doi: 10.1186/s13102-022-00454-w.
- 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.
Martin Hübner principal investigator
University Hospital CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Prehabilitation, run by Nicolas DEMARTINES 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 7 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: stopped early, as of the sponsor's last update on 23 Jun 2020. 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?
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
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?
Postoperative morbidity (time frame: Up to 30 postoperative days). 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 NCT02953119, which also lists 1 linked publication.
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 Jun 2020.