Suspended

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

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What is being tested

Early mobilization program

Behavioral
Who is being recruted

Behavior

+ Motor Activity

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: December 2014
See protocol details

Summary

Principal SponsorInstituto do Cancer do Estado de São Paulo
Study ContactElisângela PM Almeida, MDMore contacts
Last updated: August 31, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2014

Actual date on which the first participant was enrolled.

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

Principal SponsorInstituto do Cancer do Estado de São Paulo
Study ContactElisângela PM Almeida, MDMore contacts
Last updated: August 31, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMotor ActivityNeoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Early postoperative supervised aerobic exercise, resistance and flexibility training

Group II

No Intervention
Standard rehabilitation care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Instituto do Câncer do Estado de São Paulo

São Paulo, BrazilOpen Instituto do Câncer do Estado de São Paulo in Google Maps
SuspendedOne Study Center