Clinical trial NCT03466606: Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplant
Official title: Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of postoperative complications graded by Clavien Dindo classification.
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
Secondary outcomes:
measure: Length of stay
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
Other outcomes:
measure: Mortality
timeFrame: 6 months
measure: Training induced enhancement of aerobic capacity
timeFrame: baseline, after the 4-6 week endurance training program (before surgery)
measure: To evaluate de magnitude of cognitive performance change from the preoperative period to 3 months after cardiac surgery
timeFrame: At baseline and 3 months after surgery
measure: To evaluate the incidence of postoperative cognitive disfunction at 3 months after surgery
timeFrame: At 3 months after surgery
measure: Health-related quality of life
timeFrame: at baseline and after the 4-6 week endurance training program (before surgery)
measure: Analysis of the barriers for the use of communication and information technologies in prehabilitation program
timeFrame: 6 weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Graciela Martinez palli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coca-Martinez M, Lopez-Hernandez A, Montane-Muntane M, Arguis MJ, Gimeno-Santos E, Navarro-Ripoll R, Perdomo J, Lopez-Baamonde M, Rios J, Moises J, Sanz de la Garza M, Sandoval E, Romano B, Sebio R, Dana F, Martinez-Palli G. Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol. BMJ Open. 2020 Dec 22;10(12):e039885. doi: 10.1136/bmjopen-2020-039885.