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

Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01693172
• Other study ID #: 118/12
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2012
• Last updated: August 27, 2015
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neoplasm

Intervention

Behavioral:
• Early mobilization program
Early postoperative supervised aerobic exercise, resistance and flexibility training

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to walk three meters or crossing a room without assistence		at 5 days after surgery or at hospital discharge	Yes
Secondary	fatigue	We will assess the level of fatigue through the Piper fatigue scale	at 5 and 30 days after surgery	Yes
Secondary	quality of life		at 5, 30, 180 and 365 days after surgery	Yes
Secondary	length of hospital stay		at hospital discharge	Yes
Secondary	recurrence of cancer		at 180 days after surgery	Yes
Secondary	hospital costs		at 180 days after surgery	Yes
Secondary	post operatorative complications	Clavien classification	at 30 days after surgery	Yes