Effect of a Preoperative Exercise in the Postoperative Patients Undergoing Surgery for Resection of Colorectal Neoplasia : a Randomized Pilot Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Information provided by (Responsible Party):
Elisangela P M de Almeida, MD, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01693172
First received: September 7, 2012
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

The aim of this study is to evaluate the effect of a preoperative program of supervised rehabilitation on functional capacity and incidence of postoperative complications in patients undergoing elective surgery for treatment of colorectal neoplasia.


Condition Intervention
Colorectal Neoplasm
Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Preoperative Supervised Exercise in the Evolution of Postoperative Patients Undergoing Surgery for Resection of Colorectal Neoplasia : a Randomized Pilot Trial

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • functional capacity (the six-minute walk test) [ Time Frame: at 8 weeks after surgery or at hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fatigue [ Time Frame: at 60 days after surgery ] [ Designated as safety issue: Yes ]
    We will assess the level of fatigue through the Piper fatigue scale

  • quality of life [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • length of hospital stay [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • recurrence of cancer [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • hospital costs [ Time Frame: at 180 days after surgery ] [ Designated as safety issue: Yes ]
  • post operatorative complications [ Time Frame: at 28 days after surgery ] [ Designated as safety issue: Yes ]
    Clavien classification


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exercise preoperative
supervised aerobic exercise and resistance in 4-8 weeks pre-operative, three times a week
Behavioral: exercise
supervised aerobic exercise and resistance in 4-8 weeks pre-operative, three times a week
No Intervention: Standard
Lifestyle counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colorectal cancer who will undergo surgical 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693172

Locations
Brazil
Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, Brazil, 01246000
Contact: Elisângela PM Almeida, MD    551138932000    elismarinho@usp.br   
Principal Investigator: Elisângela PM Almeida, MD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Principal Investigator: Ludhmila A Hajjar, MD, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Elisangela P M de Almeida, MD, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01693172     History of Changes
Other Study ID Numbers: 118/12
Study First Received: September 7, 2012
Last Updated: July 20, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cancer do Estado de São Paulo:
exercise
colorectal neoplasms

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014