Validity and reproducibility of practical performance-based tests to estimate aerobic capacity in patients scheduled for elective colorectal surgery

Recruiting

Conditions: bowel cancer
Colorectal cancer
10017991

Registration Number: NL-OMON55879

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

In order to be eligible to participate in this study, a potential participant
must meet all of the following criteria:
- patients, males and females, >18 years of age, newly diagnosed with
colorectal cancer (stage I-IV);
- patients who undergo elective colorectal surgery at the Maastricht UMC+;
- patients without contraindications for exercise testing (physical activity
readiness questionnaire);
- patients who gave informed consent to participate in this study.

Exclusion Criteria

A potential participant who meets any of the following criteria will be
excluded from participation in this study:
- patients undergoing acute (emergency) surgery;
- patients undergoing neoadjuvant therapy in the time between the usual
preoperative screening of physical fitness (usual care) and the study visit;
- patients with a medical status that contraindicates exercise or exercise
testing;
- patients with morbid obesity (body mass index >35 kg/m2);
- patients who are unable to perform exercise testing at a cycle ergometer (for
cardiopulmonary exercise testing and the steep ramp test), as well as patients
who are unable to perform the 3-minute step test;
- patients who are unable to cooperate with the testing procedures (e.g.
insufficient understanding of the Dutch language).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to determine the criterion validity of the steep ramp<br /><br>test to estimate the ventilatory anaerobic threshold and oxygen uptake at peak<br /><br>exercise attained during maximal cardiopulmonary exercise testing in patients<br /><br>undergoing elective colorectal surgery, by evaluating the correlation of the<br /><br>primary outcome measure of the steep ramp test (achieved peak work rate) with<br /><br>the ventilatory anaerobic threshold and oxygen uptake at peak exercise as<br /><br>measured directly during cardiopulmonary exercise testing preoperatively in<br /><br>these patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following secondary objective will be addressed for the purpose of<br /><br>obtaining more insight into the validity of the steep ramp test. The<br /><br>differences of scores of the steep ramp test between relevant patient subgroups<br /><br>will be tested to assess discriminative validity of the test.</p><br>