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

Not Applicable

Completed

• Conditions: Abdominal Surgical Patient; High-risk Patient
• Interventions: Behavioral: Prehabilitation

• Registration Number: NCT02024776
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2013-12-31
• Study Start: 2014-02-01
• Primary Completion: 2016-08-30
• Study Completion: 2017-01-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Prehabilitation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Length of stay	30 days or the postoperative hospital stay if longer than 30 days

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain