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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Personalized supervised resistance training and program to promote physical activity and healthy lifestyles |
|
| Control | No Intervention | Conventional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-habilitation | Behavioral | Personalized supervised resistance training and program to promote physical activity and healthy lifestyles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days or the postoperative hospital stay if longer than 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery) | 30 days or the postoperative hospital stay if longer than 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Yes or no | 6 months |
| Training induced enhancement of aerobic capacity | Endurance time variation pre- and post intervention | baseline, after the 4-6 week endurance training program (before surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graciela Martinez palli, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain | |||
| Hospital Clinic Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40673713 | Derived | 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. | |
| 39123146 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2018 |
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| To evaluate de magnitude of cognitive performance change from the preoperative period to 3 months after cardiac surgery | two questions exploring subjective cognitive, and eight tests exploring different cognitive domains (Memory Alteration Test, the digit forwards and backwards from the Wechsler Adult Intelligence Scale, forms A and B from the Trail Making Test, the Symbol Digit Modalities Test, the Semantic Fluency Test, and the Mini-Mental State Examination (MMSE). | At baseline and 3 months after surgery |
| To evaluate the incidence of postoperative cognitive disfunction at 3 months after surgery | two questions exploring subjective cognitive, and eight tests exploring different cognitive domains (Memory Alteration Test, the digit forwards and backwards from the Wechsler Adult Intelligence Scale, forms A and B from the Trail Making Test, the Symbol Digit Modalities Test, the Semantic Fluency Test and the Mini-Mental State Examination (MMSE). | At 3 months after surgery |
| Health-related quality of life | EuroQol-5D, EQ5D questionnaire | at baseline and after the 4-6 week endurance training program (before surgery) |
| Analysis of the barriers for the use of communication and information technologies in prehabilitation program | Specific questionnaire, study compliance | 6 weeks |
| Barcelona |
| Spain |
| Derived |
| Lopez-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. |
| 33371022 | Derived | Coca-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. |
| Aug 27, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form subproject2 general | Apr 10, 2018 | Aug 27, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form subproject2 intervention | Apr 10, 2018 | Aug 27, 2024 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form subproject1 transplantation | Aug 28, 2017 | Aug 27, 2024 | ICF_003.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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