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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Information provided by (Responsible Party):
Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01693172
First received: September 7, 2012
Last updated: January 11, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention
Neoplasm
Behavioral: Early mobilization program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Ability to walk three meters or crossing a room without assistence [ Time Frame: at 5 days after surgery or at hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fatigue [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: Yes ]
    We will assess the level of fatigue through the Piper fatigue scale

  • quality of life [ Time Frame: at 5, 30, 180 and 365 days after surgery ] [ Designated as safety issue: Yes ]
  • length of hospital stay [ Time Frame: at hospital discharge ] [ Designated as safety issue: Yes ]
  • recurrence of cancer [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • hospital costs [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • post operatorative complications [ Time Frame: at 30 days after surgery ] [ Designated as safety issue: Yes ]
    Clavien classification


Estimated Enrollment: 108
Study Start Date: December 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693172

Locations
Brazil
Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, Brazil, 01246000
Contact: Elisângela PM Almeida, MD    551138932000    elismarinho@usp.br   
Principal Investigator: Elisângela PM Almeida, MD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Principal Investigator: Ludhmila A Hajjar, MD, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Elisangela P M de Almeida, MD, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01693172     History of Changes
Other Study ID Numbers: 118/12
Study First Received: September 7, 2012
Last Updated: January 11, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cancer do Estado de São Paulo:
exercise
neoplasm

ClinicalTrials.gov processed this record on May 25, 2015