Coronary Artery DiseaseNCT03466606
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplant
A study testing pre-habilitation in people with Coronary Artery Disease and Valvular Heart Disease, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
Pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- pre-habilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Mar 2018to 2 Feb 2022
- 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
- Subproject #1: Heart transplant candidates
- Subproject #2: Patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks
Who cannot join
- Dynamic left ventricular outflow tract obstruction (> 40 mmHg)
- Arrythmia induced by exercise
- Emergent surgery
- Unstable cardiac disease
- Unstable severe co-morbid disease
- Disabling orthopedic and neuromuscular disease
- Cognitive impairment
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Clinic Barcelona
Barcelona
About this study
Official title: Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery
Pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. The experience in patients at risk for cardiac surgery, one of those associated with higher morbidity and mortality, is anecdotal. Main objective: to evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for the improvement of preoperative functional capacity in high-risk and intermediate risk groups for cardiac surgery and its impact on the reduction of postoperative complications (primary endpoint). Secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii) evaluation of information and communication technologies (ICT) as a support for the pre-habilitation, and (iv) design and validation of indicators for a future large-scale implementation of this type of intervention.
Design: Subproject: #1: Prospective study of the efficacy of prehabilitation in heart transplant candidates during the study period. The results will be compared with historical records; #2: Randomized controlled trial with a 1:1 ratio to assess the efficacy of prehabilitation in patients undergoing elective coronary revascularization or valve replacement surgery. Subjects: Subproject #1: 40 patients candidates for heart transplantation. Subproject #2: 80 patients in the prehabilitation group and 80 controls in which a conventional treatment will be performed. Intervention: (i) personalized supervised resistance training, and (ii) program to promote physical activity and healthy lifestyles. The overall duration of the intervention is estimated to be at least 4-6 weeks (variable in each subproject). The support with ICTs will be a significant aspect of the program in which the adaptation of the personal health folder of Catalonia (Cat@SalutLaMevaSalut) will be fundamental.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- pre-habilitation
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-habilitationBehavioural
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Personalized supervised resistance training and program to promote physical activity and healthy lifestyles Receives: Behavioral: pre-habilitation |
| Control | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative complications graded by Clavien Dindo classification.
The classification's basic principle is to grade complications according to the treatment that is induced to treat the complication. It consists of 5 grades with 2 grades being further subdivided.
Measured: 30 days or the postoperative hospital stay if longer than 30 days
Secondary outcomes (1)
Length of stay
The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)
Measured: 30 days or the postoperative hospital stay if longer than 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start5 Mar 2018
- Primary completion10 Jun 2021
- Study completion2 Feb 2022
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 Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Graciela Martinez-Palli, Hospital Clinic of Barcelona
- Investigators
- Graciela Martinez palli, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466606
- Sponsor's protocol ID
- PI1700852
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2018
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Lopez-Baamonde M, Sanz-de la Garza M, Sandoval E, Castella M, Martinez-Palli G. Multimodal prehabilitation as a strategy to reduce postoperative complications in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):987-996. doi: 10.1097/EJA.0000000000002236. Epub 2025 Jul 16.
PubMed 40673713Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Romano-Andrioni B, Lopez-Baamonde M, Teres S, Sanz-de la Garza M, Martinez-Palli G. Differential response to preoperative exercise training in patients candidates to cardiac valve replacement. BMC Anesthesiol. 2024 Aug 9;24(1):280. doi: 10.1186/s12871-024-02671-x.
PubMed 39123146Coca-Martinez M, Lopez-Hernandez A, Montane-Muntane M, Arguis MJ, Gimeno-Santos E, Navarro-Ripoll R, Perdomo J, Lopez-Baamonde M, Rios J, Moises J, Sanz de la Garza M, Sandoval E, Romano B, Sebio R, Dana F, Martinez-Palli G. Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol. BMJ Open. 2020 Dec 22;10(12):e039885. doi: 10.1136/bmjopen-2020-039885.
PubMed 33371022
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03466606
- Acronym / sponsor ID
- PI1700852
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 15 Mar 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.
Pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. The experience in patients at risk for cardiac surgery, one of those associated with higher morbidity and mortality, is anecdotal. Main objective: to evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for the improvement of preoperative functional capacity in high-risk and intermediate risk groups for cardiac surgery and its impact on the reduction of postoperative complications (primary endpoint). Secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii) evaluation of information and communication technologies (ICT) as a support for the pre-habilitation, and (iv) design and validation of indicators for a future large-scale implementation of this type of intervention.
Design: Subproject: #1: Prospective study of the efficacy of prehabilitation in heart transplant candidates during the study period. The results will be compared with historical records; #2: Randomized controlled trial with a 1:1 ratio to assess the efficacy of prehabilitation in patients undergoing elective coronary revascularization or valve replacement surgery. Subjects: Subproject #1: 40 patients candidates for heart transplantation. Subproject #2: 80 patients in the prehabilitation group and 80 controls in which a conventional treatment will be performed. Intervention: (i) personalized supervised resistance training, and (ii) program to promote physical activity and healthy lifestyles. The overall duration of the intervention is estimated to be at least 4-6 weeks (variable in each subproject). The support with ICTs will be a significant aspect of the program in which the adaptation of the personal health folder of Catalonia (Cat@SalutLaMevaSalut) will be fundamental.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: pre-habilitationPersonalized supervised resistance training and program to promote physical activity and healthy lifestyles |
| Control | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subproject #1: Heart transplant candidates
- Subproject #2: Patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks
Key exclusion criteria (8 listed)
- Dynamic left ventricular outflow tract obstruction (> 40 mmHg)
- Arrythmia induced by exercise
- Emergent surgery
- Unstable cardiac disease
- Unstable severe co-morbid disease
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 |
|---|---|---|
| pre-habilitationPersonalized supervised resistance training and program to promote physical activity and healthy lifestyles | Behavioural | Prehabilitation |
Primary outcome
The incidence of postoperative complications graded by Clavien Dindo classification.
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
The classification's basic principle is to grade complications according to the treatment that is induced to treat the complication. It consists of 5 grades with 2 grades being further subdivided.
1 secondary outcome
Length of stay
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
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 29 Aug 2024.
- Derived from this study: PubMed 40673713Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Lopez-Baamonde M, Sanz-de la Garza M, Sandoval E, Castella M, Martinez-Palli G. Multimodal prehabilitation as a strategy to reduce postoperative complications in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):987-996. doi: 10.1097/EJA.0000000000002236. Epub 2025 Jul 16.
- Derived from this study: PubMed 39123146Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Romano-Andrioni B, Lopez-Baamonde M, Teres S, Sanz-de la Garza M, Martinez-Palli G. Differential response to preoperative exercise training in patients candidates to cardiac valve replacement. BMC Anesthesiol. 2024 Aug 9;24(1):280. doi: 10.1186/s12871-024-02671-x.
- Derived from this study: PubMed 33371022Coca-Martinez M, Lopez-Hernandez A, Montane-Muntane M, Arguis MJ, Gimeno-Santos E, Navarro-Ripoll R, Perdomo J, Lopez-Baamonde M, Rios J, Moises J, Sanz de la Garza M, Sandoval E, Romano B, Sebio R, Dana F, Martinez-Palli G. Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol. BMJ Open. 2020 Dec 22;10(12):e039885. doi: 10.1136/bmjopen-2020-039885.
- Individual participant dataSharing planned: Undecided
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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.
Graciela Martinez palli, MD, PhD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-habilitation in people with Coronary Artery Disease and Valvular Heart Disease, run by Hospital Clinic of Barcelona at 2 sites 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 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 29 Aug 2024. 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 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?
The incidence of postoperative complications graded by Clavien Dindo classification. (time frame: 30 days or the postoperative hospital stay if longer than 30 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 NCT03466606, 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 29 Aug 2024.