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

• Sponsor: Instituto do Cancer do Estado de São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01693172
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm	Behavioral: Early mobilization program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: early postoperative mobilization Early postoperative supervised aerobic exercise, resistance and flexibility training	Behavioral: Early mobilization program; Early postoperative supervised aerobic exercise, resistance and flexibility training
No Intervention: Standard Standard rehabilitation care

Outcome Measures

Primary Outcome Measures

1. Ability to walk three meters or crossing a room without assistence [at 5 days after surgery or at hospital discharge]

Secondary Outcome Measures

1. fatigue [at 5 and 30 days after surgery]

   We will assess the level of fatigue through the Piper fatigue scale

2. quality of life [at 5, 30, 180 and 365 days after surgery]

3. length of hospital stay [at hospital discharge]

4. recurrence of cancer [at 180 days after surgery]

5. hospital costs [at 180 days after surgery]

6. post operatorative complications [at 30 days after surgery]

   Clavien classification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Câncer do Estado de São Paulo	São Paulo		Brazil	01246000

Sponsors and Collaborators

• Instituto do Cancer do Estado de São Paulo

Investigators

• Principal Investigator: Ludhmila A Hajjar, MD, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elisangela P M de Almeida, MD, Principal Investigator, Instituto do Cancer do Estado de São Paulo
• ClinicalTrials.gov Identifier: NCT01693172
• Other Study ID Numbers: 118/12
• First Posted: Sep 26, 2012
• Last Update Posted: Aug 31, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Elisangela P M de Almeida, MD, Principal Investigator, Instituto do Cancer do Estado de São Paulo: exercise; neoplasm
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 31, 2015