pre-habilitation
BehavioralPersonalized supervised resistance training and program to promote physical activity and healthy lifestyles
NCT Number: NCT03466606
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hospital Clinic Barcelona, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
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.
Time frame: 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)
Time frame: 6 months
Yes or no
Time frame: baseline, after the 4-6 week endurance training program (before surgery)
Endurance time variation pre- and post intervention
Time frame: 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).
Time frame: 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).
Time frame: at baseline and after the 4-6 week endurance training program (before surgery)
EuroQol-5D, EQ5D questionnaire
Time frame: 6 weeks
Specific questionnaire, study compliance
Hospital Clinic of Barcelona
Other
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery
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