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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03466606
• Other study ID #: PI1700852
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 30, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Behavioral:
• pre-habilitation
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		6 months
Other	Training induced enhancement of aerobic capacity	Endurance time variation pre- and post intervention	baseline, after the 4-6 week endurance training program (before surgery)
Other	Health-related quality of life	EuroQol-5D, EQ5D questionnaire	at baseline and after the 4-6 week endurance training program (before surgery)
Other	Analysis of the barriers for the use of communication and information technologies in prehabilitation program	Specific questionnaire, study compliance	6 weeks
Primary	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	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