Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery

August 27, 2015 updated by: Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo

Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial

The aim of this study is to evaluate the effect of an early postoperative physical rehabilitation program on the functional capacity and incidence of postoperative complications in patients undergoing major elective surgery for treatment of a neoplasm

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

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

  • Brazil
      • São Paulo, Brazil, 01246000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:
        • Principal Investigator:
          • Elisângela PM Almeida, MD

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 who will be submitted to major surgery for cancer treatment.
  • Age ≥ 18 years
  • Reading and signing the informed consent

Exclusion Criteria:

Acute myocardial infarction (within the last 30 days)

  • Unstable Angina
  • Cardiac arrhythmia uncontrolled
  • symptomatic severe aortic stenosis
  • Congestive heart failure NYHA III or IV
  • infarction or acute pulmonary thromboembolism
  • pericarditis or myocarditis
  • Acute Endocarditis
  • Acute aortic dissection
  • Active infection
  • Acute renal failure
  • Thyrotoxicosis
  • Refusal to participate in the study
  • Inability to ambulate independently and / or inability to exercises
  • Presence of bone metastasis
  • musculoskeletal and neurological conditions that preclude the achievement of an exercise program designed for this study

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: early postoperative mobilization
Early postoperative supervised aerobic exercise, resistance and flexibility training
Behavioral: Early mobilization program
Early postoperative supervised aerobic exercise, resistance and flexibility training
NO_INTERVENTION: Standard
Standard rehabilitation care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability to walk three meters or crossing a room without assistence
Time Frame: at 5 days after surgery or at hospital discharge
at 5 days after surgery or at hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue
Time Frame: at 5 and 30 days after surgery
We will assess the level of fatigue through the Piper fatigue scale
at 5 and 30 days after surgery
quality of life
Time Frame: at 5, 30, 180 and 365 days after surgery
at 5, 30, 180 and 365 days after surgery
length of hospital stay
Time Frame: at hospital discharge
at hospital discharge
recurrence of cancer
Time Frame: at 180 days after surgery
at 180 days after surgery
hospital costs
Time Frame: at 180 days after surgery
at 180 days after surgery
post operatorative complications
Time Frame: at 30 days after surgery
Clavien classification
at 30 days after surgery

Collaborators and Investigators

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

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Ludhmila A Hajjar, MD, PhD, University of Sao Paulo

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

December 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 23, 2012

First Posted (ESTIMATE)

September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118/12

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.

Clinical Trials on Neoplasm

Clinical Trials on Early mobilization program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe