NeoplasmNCT01693172
Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery
A study testing Early mobilization program in people with Neoplasm, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Early mobilization program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will be submitted to major surgery for cancer treatment.
- Age ≥ 18 years
- Reading and signing the informed consent
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246000
Elisângela PM Almeida, MD, 551138932000, elismarinho@usp.br
Elisângela PM Almeida, MD
About this study
Official title: Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial
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
- Conditions
- Neoplasm
- Being tested
- Early mobilization program
- Keywords
- exercise, neoplasm
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization programBehavioural
Early postoperative supervised aerobic exercise, resistance and flexibility training
| Study group | Role | What they receive |
|---|---|---|
| early postoperative mobilization | Active comparator | Early postoperative supervised aerobic exercise, resistance and flexibility training Receives: Behavioral: Early mobilization program |
| Standard | No intervention | Standard rehabilitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to walk three meters or crossing a room without assistence
Measured: at 5 days after surgery or at hospital discharge
Secondary outcomes (6)
fatigue
We will assess the level of fatigue through the Piper fatigue scale
Measured: at 5 and 30 days after surgery
quality of life
Measured: at 5, 30, 180 and 365 days after surgery
length of hospital stay
Measured: at hospital discharge
recurrence of cancer
Measured: at 180 days after surgery
hospital costs
Measured: at 180 days after surgery
post operatorative complications
Clavien classification
Measured: at 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo
- Investigators
- Ludhmila A Hajjar, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693172
- Sponsor's protocol ID
- 118/12
- Status last verified
- Aug 2015
- First submitted
- 7 Sep 2012
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28981596
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01693172
- Acronym / sponsor ID
- 118/12
- Conditions
- Neoplasm
- Keywords
- exercise, neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early postoperative mobilization | Active comparator | Behavioral: Early mobilization programEarly postoperative supervised aerobic exercise, resistance and flexibility training |
| Standard | No intervention | –Standard rehabilitation care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be submitted to major surgery for cancer treatment.
- Age ≥ 18 years
- Reading and signing the informed consent
Key exclusion criteria (16 listed)
- Acute myocardial infarction (within the last 30 days)
- Unstable Angina
- Cardiac arrhythmia uncontrolled
- symptomatic severe aortic stenosis
- Congestive heart failure NYHA III or IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilization programEarly postoperative supervised aerobic exercise, resistance and flexibility training | Behavioural | early postoperative mobilization |
Primary outcome
Ability to walk three meters or crossing a room without assistence
Time frame: at 5 days after surgery or at hospital discharge
6 secondary outcomes
fatigue
Time frame: at 5 and 30 days after surgery
quality of life
Time frame: at 5, 30, 180 and 365 days after surgery
length of hospital stay
Time frame: at hospital discharge
recurrence of cancer
Time frame: at 180 days after surgery
hospital costs
Time frame: at 180 days after surgery
post operatorative complications
Time frame: at 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Derived from this study: PubMed 28981596de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludhmila A Hajjar, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization program in people with Neoplasm, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to walk three meters or crossing a room without assistence (time frame: at 5 days after surgery or at hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.