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

Not Applicable

• Conditions: Neoplasm
• Interventions: Behavioral: Early mobilization program

• Registration Number: NCT01693172
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-23
• Study First Posted: 2012-09-26
• Study Start: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-31
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early postoperative mobilization	Early mobilization program	Early postoperative supervised aerobic exercise, resistance and flexibility training

Primary Outcome Measures

Name	Time	Method
Ability to walk three meters or crossing a room without assistence	at 5 days after surgery or at hospital discharge

Secondary Outcome Measures

Name	Time	Method
hospital costs	at 180 days after surgery
fatigue	at 5 and 30 days after surgery	We will assess the level of fatigue through the Piper fatigue scale
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	Clavien classification

Trial Locations

Locations (1)

Instituto do Câncer do Estado de São Paulo; 🇧🇷 São Paulo, Brazil