Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplant
- Conditions
- Coronary Artery DiseaseValvular Heart Disease
- Interventions
- Behavioral: pre-habilitation
- Registration Number
- NCT03466606
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation pre-habilitation Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
- Primary Outcome Measures
Name Time Method The incidence of postoperative complications graded by Clavien Dindo classification. 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.
- Secondary Outcome Measures
Name Time Method Length of stay 30 days or the postoperative hospital stay if longer than 30 days The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)
Trial Locations
- Locations (2)
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain