Effectiveness of Prehabilitation Program for High-risk Patients Underwent Abdominal Surgery

Study Overview
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Brief Summary
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Despite recent advances, morbidity and mortality associated to major abdominal surgery is significant. A poor physical condition and functional status reduces the ability of a person to cope, mentally and physically, with hospitalization and surgery and may compromise functional recovery, potentially leading to postoperative complications and death. Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery and eventually the prognosis of the surgical patient. Whereas the benefits of cardiopulmonary fitness programs are well established, the accessibility, sustainability of effects, and impact on the surgical outcome of these programs are unsolved issues. Wellness programs based on integrated care services supported by Information and Communication Technology (ICT) can overcome such limitations. The investigators hypothesized that a prehabilitation program, inducing beneficial effects on exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT support may contribute to increase the adherence and sustainability of this intervention.

Official Title
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The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial

Conditions
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Abdominal Surgical Patient, High-risk Patient

Intervention / Treatment
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* Behavioral: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 70 years-old and/or American Society of Anesthesiologists (ASA) health status class III-IV, with a DASI (Duke Activity Score Index) <46 points, referred for scheduled major abdominal surgery Exclusion Criteria: Unstable severe co-morbid disease Dementia and psychosis, severe mental disorder or substance abuse or dependence Disabling orthopedic and neuromuscular disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehabilitation<br>Prehabilitation program is defined as a tailored physical exercise program to be carried out to a patient on the basis of his/her health condition, social circumstances and adherence profile. The intervention consisted of a standard 4-6 week supervised outpatient program including global endurance exercise training, or educational sessions followed by a self-management program supported by ICT during the follow-up period, or a combination of both. | Behavioral: Prehabilitation<br>* Tailored exercise training program<br>|
| No Intervention: No-intervention<br>Standard counseling and conventional pre-surgical measures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative complications, classified by Clavien Scale |  | Time Frame: 30days or the postoperative hospital stay if longer than 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | 30 days or the postoperative hospital stay if longer than 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal surgery, Training, Wellness, Aerobic capacity, Information and communication technology, surgical risk