Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prehabilitation Personalized supervised resistance training and program to promote physical activity and healthy lifestyles |
Behavioral: pre-habilitation
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
|
| No Intervention: Control Conventional treatment |
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Other Outcome Measures
- Mortality [6 months]
- Training induced enhancement of aerobic capacity [baseline, after the 4-6 week endurance training program (before surgery)]
Endurance time variation pre- and post intervention
- Health-related quality of life [at baseline and after the 4-6 week endurance training program (before surgery)]
EuroQol-5D, EQ5D questionnaire
- Analysis of the barriers for the use of communication and information technologies in prehabilitation program [6 weeks]
Specific questionnaire, study compliance
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subproject #1: Heart transplant candidates
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Subproject #2: Patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks
Exclusion Criteria:
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Dynamic left ventricular outflow tract obstruction (> 40 mmHg)
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Arrythmia induced by exercise
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Emergent surgery
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Unstable cardiac disease
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Unstable severe co-morbid disease
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Disabling orthopedic and neuromuscular disease
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Cognitive impairment
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Refusal to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
| 2 | Hospital Clinic Barcelona | Barcelona | Spain |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
- Instituto de Salud Carlos III
Investigators
- Principal Investigator: Graciela Martinez palli, MD, PhD, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI1700852