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Clinical Trials/NCT02024776
NCT02024776
Completed
Not Applicable

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

Hospital Clinic of Barcelona1 site in 1 country141 target enrollmentFebruary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Surgical Patient
Sponsor
Hospital Clinic of Barcelona
Enrollment
141
Locations
1
Primary Endpoint
The incidence of postoperative complications, classified by Clavien Scale
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
January 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Graciela Martinez-Palli

MD, PhD

Hospital Clinic of Barcelona

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The incidence of postoperative complications, classified by Clavien Scale

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

Secondary Outcomes

  • Length of stay(30 days or the postoperative hospital stay if longer than 30 days)

Study Sites (1)

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