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Clinical Trials/NCT01693172
NCT01693172
Unknown
Not Applicable

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

Instituto do Cancer do Estado de São Paulo1 site in 1 country108 target enrollmentDecember 2014
ConditionsNeoplasm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasm
Sponsor
Instituto do Cancer do Estado de São Paulo
Enrollment
108
Locations
1
Primary Endpoint
Ability to walk three meters or crossing a room without assistence
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto do Cancer do Estado de São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Elisangela P M de Almeida, MD

Principal Investigator

Instituto do Cancer do Estado de São Paulo

Eligibility 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

Outcomes

Primary Outcomes

Ability to walk three meters or crossing a room without assistence

Time Frame: at 5 days after surgery or at hospital discharge

Secondary Outcomes

  • hospital costs(at 180 days after surgery)
  • fatigue(at 5 and 30 days after surgery)
  • quality of life(at 5, 30, 180 and 365 days after surgery)
  • length of hospital stay(at hospital discharge)
  • recurrence of cancer(at 180 days after surgery)
  • post operatorative complications(at 30 days after surgery)

Study Sites (1)

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