Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplantation
Primary Purpose
Coronary Artery Disease, Valvular Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
pre-habilitation
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic de Barcelona
- Hospital Clinic Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation
Control
Arm Description
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
Conventional treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Length of stay
The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)
Full Information
NCT ID
NCT03466606
First Posted
February 27, 2018
Last Updated
August 5, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT03466606
Brief Title
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplantation
Official Title
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional treatment
Intervention Type
Behavioral
Intervention Name(s)
pre-habilitation
Intervention Description
Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
Primary Outcome Measure Information:
Title
The incidence of postoperative complications graded by Clavien Dindo classification.
Description
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.
Time Frame
30 days or the postoperative hospital stay if longer than 30 days
Secondary Outcome Measure Information:
Title
Length of stay
Description
The total length, in days, that patient stays in a hospital after surgery (including the day of the surgery)
Time Frame
30 days or the postoperative hospital stay if longer than 30 days
Other Pre-specified Outcome Measures:
Title
Mortality
Time Frame
6 months
Title
Training induced enhancement of aerobic capacity
Description
Endurance time variation pre- and post intervention
Time Frame
baseline, after the 4-6 week endurance training program (before surgery)
Title
Health-related quality of life
Description
EuroQol-5D, EQ5D questionnaire
Time Frame
at baseline and after the 4-6 week endurance training program (before surgery)
Title
Analysis of the barriers for the use of communication and information technologies in prehabilitation program
Description
Specific questionnaire, study compliance
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graciela Martinez palli, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33371022
Citation
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.
Results Reference
derived
Learn more about this trial
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplantation
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