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

NCT03466606 | Completed

• 1 other identifier: PI1700852
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative complications graded by Clavien Dindo classification.

  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.

  30 days or the postoperative hospital stay if longer than 30 days

Secondary Outcomes (1)

• Length of stay

  30 days or the postoperative hospital stay if longer than 30 days

Other Outcomes (6)

• Mortality

  6 months

• Training induced enhancement of aerobic capacity

  baseline, after the 4-6 week endurance training program (before surgery)

• 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

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Behavioral: pre-habilitation

Control

NO INTERVENTION

Conventional treatment

Interventions

pre-habilitation BEHAVIORAL

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

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (2)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Related Publications (3)

• Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Lopez-Baamonde M, Sanz-de la Garza M, Sandoval E, Castella M, Martinez-Palli G. Multimodal prehabilitation as a strategy to reduce postoperative complications in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):987-996. doi: 10.1097/EJA.0000000000002236. Epub 2025 Jul 16.

  PMID: 40673713 DERIVED

• Lopez-Hernandez A, Gimeno-Santos E, Navarro-Ripoll R, Arguis MJ, Romano-Andrioni B, Lopez-Baamonde M, Teres S, Sanz-de la Garza M, Martinez-Palli G. Differential response to preoperative exercise training in patients candidates to cardiac valve replacement. BMC Anesthesiol. 2024 Aug 9;24(1):280. doi: 10.1186/s12871-024-02671-x.

  PMID: 39123146 DERIVED

• 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.

  PMID: 33371022 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Graciela Martinez palli, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia Department

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 15, 2018
• Study Start: March 5, 2018
• Primary Completion: June 10, 2021
• Study Completion: February 2, 2022
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

ES (2)