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

April 16, 2019 updated by: Graciela Martinez-Palli, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Behavioral: Prehabilitation
Tailored exercise training program
NO_INTERVENTION: No-intervention
Standard counseling and conventional pre-surgical measures

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 months
6 months
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
baseline, after the 4-6 week endurance training program (before surgery), and at 3 and 6 months follow-up
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
at baseline and after the 4-6 week endurance training program(before surgery), and at 3 and 6 months follow-up
Analysis of the barriers for the use of communication and information technologies in prehabilitation program
Time Frame: Frame: 6 weeks
Frame: 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Graciela Martinez Palli, Hospital Clinic de Barcelona, IDIBAPS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2014

Primary Completion (ACTUAL)

August 30, 2016

Study Completion (ACTUAL)

January 30, 2017

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

December 31, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI13/00425 (OTHER_GRANT: Instituto de Salud Carlos III)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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