Coronary Artery Disease, Valvular Heart Disease
Conditions
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.
Interventions
BEHAVIORALpre-habilitation
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
Sponsors
Instituto de Salud Carlos III
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate de magnitude of cognitive performance change from the preoperative period to 3 months after cardiac surgery | At baseline and 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). |
| To evaluate the incidence of postoperative cognitive disfunction at 3 months after surgery | 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). |
| Mortality | 6 months | Yes or no |
| Analysis of the barriers for the use of communication and information technologies in prehabilitation program | 6 weeks | Specific questionnaire, study compliance |
| Health-related quality of life | at baseline and after the 4-6 week endurance training program (before surgery) | EuroQol-5D, EQ5D questionnaire |
| Training induced enhancement of aerobic capacity | baseline, after the 4-6 week endurance training program (before surgery) | Endurance time variation pre- and post intervention |
Countries
Spain
Outcome results
None listed