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Impact of a Preoperative Exercise in the Postoperative Patients Undergoing Surgery for Resection of Colorectal Neoplasia

This study is currently recruiting participants.
Verified September 2012 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: September 29, 2012
Last verified: September 2012
History of Changes
  Purpose

The aim of this study is to evaluate the impact 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: Impact of a Preoperative Supervised Exercise in the Evolution of Postoperative Patients Undergoing Surgery for Resection of Colorectal Neoplasia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • functional capacity (the six-minute walk test) and days alive and free of organ dysfunction [ Time Frame: at 28-days after surgery or at hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • fatigue [ Time Frame: at 180 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 ]
  • cardiopulmonary capacity [ Time Frame: at 30 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 ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (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
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: September 29, 2012
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:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013