Skip to main content
OpenTrials
Completed

NCT Number: NCT03466606

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre-habilitation

Behavioral

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

Primary outcomes

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

    Time frame: 30 days or the postoperative hospital stay if longer than 30 days

    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.

Secondary outcomes

  1. Length of stay

    Time frame: 30 days or the postoperative hospital stay if longer than 30 days

    The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)

Other outcomes

  1. Mortality

    Time frame: 6 months

    Yes or no

  2. Training induced enhancement of aerobic capacity

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

    Endurance time variation pre- and post intervention

  3. To evaluate de magnitude of cognitive performance change from the preoperative period to 3 months after cardiac surgery

    Time frame: At baseline and 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).

  4. To evaluate the incidence of postoperative cognitive disfunction at 3 months after surgery

    Time frame: 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).

  5. Health-related quality of life

    Time frame: at baseline and after the 4-6 week endurance training program (before surgery)

    EuroQol-5D, EQ5D questionnaire

  6. Analysis of the barriers for the use of communication and information technologies in prehabilitation program

    Time frame: 6 weeks

    Specific questionnaire, study compliance

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2018
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.