Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery
1 other identifier
interventional
108
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedAugust 31, 2015
August 1, 2015
1 year
September 7, 2012
August 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ability to walk three meters or crossing a room without assistence
at 5 days after surgery or at hospital discharge
Secondary Outcomes (6)
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
hospital costs
at 180 days after surgery
- +1 more secondary outcomes
Study Arms (2)
early postoperative mobilization
ACTIVE COMPARATOREarly postoperative supervised aerobic exercise, resistance and flexibility training
Standard
NO INTERVENTIONStandard rehabilitation care
Interventions
Early postoperative supervised aerobic exercise, resistance and flexibility training
Eligibility Criteria
You may qualify if:
- Patients who will be submitted to major surgery for cancer treatment.
- Age ≥ 18 years
- Reading and signing the informed consent
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246000, Brazil
Related Publications (1)
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.
PMID: 28981596DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludhmila A Hajjar, MD, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 26, 2012
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
August 31, 2015
Record last verified: 2015-08