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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Valvular Heart Disease
• Intervention / Treatment: Behavioral: pre-habilitation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital Clinic Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; Personalized supervised resistance training and program to promote physical activity and healthy lifestyles	Behavioral: pre-habilitation; Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
No Intervention: Control; Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)	30 days or the postoperative hospital stay if longer than 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training induced enhancement of aerobic capacity	Endurance time variation pre- and post intervention	baseline, after the 4-6 week endurance training program (before surgery)
Health-related quality of life	EuroQol-5D, EQ5D questionnaire	at baseline and after the 4-6 week endurance training program (before surgery)
Analysis of the barriers for the use of communication and information technologies in prehabilitation program	Specific questionnaire, study compliance	6 weeks
Mortality	Yes or no	6 months
To evaluate de magnitude of cognitive performance change from the preoperative period to 3 months after cardiac 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).	At baseline and 3 months after surgery
To evaluate the incidence of postoperative cognitive disfunction 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).	At 3 months after surgery

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Graciela Martinez palli, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): February 2, 2022

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: PI1700852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No