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

Study Overview
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Brief Summary
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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

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

Conditions
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Neoplasm

Intervention / Treatment
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* Behavioral: Early mobilization program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early postoperative mobilization<br>Early postoperative supervised aerobic exercise, resistance and flexibility training | Behavioral: Early mobilization program<br>* Early postoperative supervised aerobic exercise, resistance and flexibility training<br>|
| No Intervention: Standard<br>Standard rehabilitation care | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | We will assess the level of fatigue through the Piper fatigue scale | 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 | 
| hospital costs |  | at 180 days after surgery | 
| post operatorative complications | Clavien classification | at 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, neoplasm