Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplant

Hospital Clinic of Barcelona

Status: Completed

Conditions: Coronary Artery Disease; Valvular Heart Disease

Treatments: Behavioral: pre-habilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03466606

PI1700852

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

Personalized supervised resistance training and program to promote physical activity and healthy lifestyles

Treatment:

Behavioral: pre-habilitation

Control

No Intervention group

Description:

Conventional treatment