Skip to main content
OpenTrials
Completed

NCT Number: NCT02024776

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

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.

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 de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Prehabilitation

Behavioral

Tailored exercise training program

Primary outcomes

  1. 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

  1. Length of stay

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

Other outcomes

  1. Mortality

    Time frame: 6 months

  2. Training induced enhancement of aerobic capacity : VO2 max, Endurance time, 6 MWT (m)

    Time frame: baseline, after the 4-6 week endurance training program (before surgery), and at 3 and 6 months follow-up

  3. Health-related quality of life (SF-36)

    Time frame: at baseline and after the 4-6 week endurance training program(before surgery), and at 3 and 6 months follow-up

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

    Time frame: Frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 31, 2013
Registry last updated
Apr 17, 2019

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.