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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2022-02-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prehabilitation

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

Group Type EXPERIMENTAL

pre-habilitation

Intervention Type BEHAVIORAL

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

Control

Conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pre-habilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No