Chronic DiseaseNCT03767387
Protocol for Prehabilitation Service Implementation in Catalonia
A study testing Trimodal Prehabilitation in people with Chronic Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Trimodal prehabilitation consists of a short-term (~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Trimodal Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 1 Oct 2019
- 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 old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.
- Patients at high-risk for surgical complications defined by age > 70 years old and/or American Society of Anesthesiologists 3-4.
Who cannot join
- Non-elective surgery
- Metastatic disease known preoperatively
- Unstable cardiac or respiratory disease
- Locomotor limitations precluding exercise performance
- Cognitive deterioration impeding adherence to the program
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
Barcelona, Catalonia, 08036
About this study
Trimodal prehabilitation consists of a short-term (~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. The final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.
Read the detailed description
This is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support.
The intervention is currently deployed as mainstream service at Hospital Clinic in several types of major surgeries. During fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. The outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care.
The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for regional scalability of the service. It is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. The patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). Study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA) scoring.
- Conditions
- Chronic Disease
- Being tested
- Trimodal Prehabilitation
- Keywords
- Prehabilitation, Physical Activity, Integrated Care, Collaborative Self-management
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimodal PrehabilitationOther
Prehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation + standard care | Active comparator | Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery Receives: Other: Trimodal Prehabilitation |
| Standard care | No intervention | Standard care before major surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost-effectiveness
Health care costs
Measured: 4 weeks
Secondary outcomes (8)
Complications
number of complications per patient
Measured: 4 weeks
Length of stay
hospital and intensive care unit length of stay,
Measured: 4 weeks
Number of hospital readmissions
30-day hospital readmissions rate
Measured: 4 weeks
Number of Emergency room visits
30-day emergency room visits rate
Measured: 4 weeks
Meters achieved in the six-minute walk test
Aerobic capacity
Measured: 4 weeks
Yale Physical Activity Survey (YPAS)
Physical activity assessed by the YPAS (Range 0-100) Higher values represent better
Measured: 4 weeks
Health status assessed by 36-Item Short Form Survey (SF-36)
Health status related quality of life (Range 0-100) Higher values represent better
Measured: 4 weeks
Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
Psychological status (Range 0-21) Higher values represent worst
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Nov 2018
- Primary completion1 Aug 2019
- Study completion1 Oct 2019
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 Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Roca, Hospital Clinic of Barcelona
- Investigators
- Josep Roca, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767387
- Sponsor's protocol ID
- NEXTCARE-PREHAB
- Status last verified
- Feb 2020
- First submitted
- 3 Dec 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barberan-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 28489682
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Prehabilitation Service Implementation in Catalonia
- ClinicalTrials.gov ID
- NCT03767387
- Acronym / sponsor ID
- NEXTCARE-PREHAB
- Conditions
- Chronic Disease
- Keywords
- Prehabilitation, Physical Activity, Integrated Care, Collaborative Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 Dec 2018 (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.
Trimodal prehabilitation consists of a short-term (~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. The final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.
Detailed description
This is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support.
The intervention is currently deployed as mainstream service at Hospital Clinic in several types of major surgeries. During fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. The outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care.
The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for regional scalability of the service. It is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. The patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). Study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA) scoring.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation + standard care | Active comparator | Other: Trimodal PrehabilitationTrimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery |
| Standard care | No intervention | –Standard care before major surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.
- Patients at high-risk for surgical complications defined by age > 70 years old and/or American Society of Anesthesiologists 3-4.
Key exclusion criteria (5 listed)
- Non-elective surgery
- Metastatic disease known preoperatively
- Unstable cardiac or respiratory disease
- Locomotor limitations precluding exercise performance
- Cognitive deterioration impeding adherence to the program
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 |
|---|---|---|
| Trimodal PrehabilitationPrehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program. | Other | Prehabilitation + standard care |
Primary outcome
cost-effectiveness
Time frame: 4 weeks
Health care costs
8 secondary outcomes
Complications
Time frame: 4 weeks
Length of stay
Time frame: 4 weeks
Number of hospital readmissions
Time frame: 4 weeks
Number of Emergency room visits
Time frame: 4 weeks
Meters achieved in the six-minute walk test
Time frame: 4 weeks
Yale Physical Activity Survey (YPAS)
Time frame: 4 weeks
Health status assessed by 36-Item Short Form Survey (SF-36)
Time frame: 4 weeks
Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
Time frame: 4 weeks
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 13 Feb 2020.
- 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.
- 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.
Josep Roca, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimodal Prehabilitation in people with Chronic Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 13 Feb 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 Spain. 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?
cost-effectiveness (time frame: 4 weeks). 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 NCT03767387, 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 13 Feb 2020.