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

NCT ID: NCT01693172

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-01-31

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

Detailed Description

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Conditions

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Neoplasm

Keywords

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exercise neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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early postoperative mobilization

Early postoperative supervised aerobic exercise, resistance and flexibility training

Group Type ACTIVE_COMPARATOR

Early mobilization program

Intervention Type BEHAVIORAL

Early postoperative supervised aerobic exercise, resistance and flexibility training

Standard

Standard rehabilitation care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early mobilization program

Early postoperative supervised aerobic exercise, resistance and flexibility training

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Elisangela P M de Almeida, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ludhmila A Hajjar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Elisângela PM Almeida, MD

Role: primary

References

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de Almeida EPM, de Almeida JP, Landoni G, Galas FRBG, Fukushima JT, Fominskiy E, de Brito CMM, Cavichio LBL, de Almeida LAA, Ribeiro U Jr, Osawa EA, Diz MP, Cecatto RB, Battistella LR, Hajjar LA. Early mobilization programme improves functional capacity after major abdominal cancer surgery: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):900-907. doi: 10.1093/bja/aex250.

Reference Type DERIVED
PMID: 28981596 (View on PubMed)

Other Identifiers

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118/12

Identifier Type: -

Identifier Source: org_study_id