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

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ClinicalTrials.gov Identifier: NCT01693172
Recruitment Status : Unknown
Verified August 2015 by Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Recruiting
First Posted : September 26, 2012
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Behavioral: Early mobilization program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

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



Primary Outcome Measures :
  1. Ability to walk three meters or crossing a room without assistence [ Time Frame: at 5 days after surgery or at hospital discharge ]

Secondary Outcome Measures :
  1. fatigue [ Time Frame: at 5 and 30 days after surgery ]
    We will assess the level of fatigue through the Piper fatigue scale

  2. quality of life [ Time Frame: at 5, 30, 180 and 365 days after surgery ]
  3. length of hospital stay [ Time Frame: at hospital discharge ]
  4. recurrence of cancer [ Time Frame: at 180 days after surgery ]
  5. hospital costs [ Time Frame: at 180 days after surgery ]
  6. post operatorative complications [ Time Frame: at 30 days after surgery ]
    Clavien classification



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo:
exercise
neoplasm