We aim to determine the validity of the steep ramp test as practical performance-based aerobic capacity test in patients undergoing elective colorectal resection by correlating the tests* scores with the ventilatory anaerobic threshold and oxygen…
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Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
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Intervention
Outcome measures
Primary outcome
The primary objective is to determine the criterion validity of the steep ramp
test to estimate the ventilatory anaerobic threshold and oxygen uptake at peak
exercise attained during maximal cardiopulmonary exercise testing in patients
undergoing elective colorectal surgery, by evaluating the correlation of the
primary outcome measure of the steep ramp test (achieved peak work rate) with
the ventilatory anaerobic threshold and oxygen uptake at peak exercise as
measured directly during cardiopulmonary exercise testing preoperatively in
these patients.
Secondary outcome
The following secondary objective will be addressed for the purpose of
obtaining more insight into the validity of the steep ramp test. The
differences of scores of the steep ramp test between relevant patient subgroups
will be tested to assess discriminative validity of the test.
Background summary
The primary treatment for colorectal cancer is surgical resection of the tumor.
Undergoing major surgery is like running a marathon, and requires an optimal
physical fitness of patients in order to cope with the surgical stress and
hospitalization. Preoperative aerobic capacity, measured during cardiopulmonary
exercise testing, has been found to have a consistent positive relation with
postoperative outcome in elective major intra-abdominal surgery (e.g. less
morbidity, shorter length of hospital stay, and lower mortality). Hence,
cardiopulmonary exercise testing can be used to identify patients with an
increased risk for postoperative morbidity, an increased length of stay and/or
an increased mortality risk. Preoperative exercise training of high-risk
patients to improve their aerobic capacity (prehabilitation) is beneficial for
preventing peri- and/or postoperative complications, reducing
morbidity/mortality, and facilitating a swift return to an adequate performance
of activities of daily living. However, performing cardiopulmonary exercise
testing - requiring respiratory gas analysis measurements - is sometimes not
feasible due to the expense, the need for special equipment, and the required
trained staff. Therefore, the use of practical and inexpensive alternative
performance-based aerobic capacity tests might increase the incorporation of
objectively measured exercise capacity to estimate aerobic capacity for
preoperative risk strati*cation. The steep ramp test and 3-minute step test
might be useful, non-sophisticated, alternative performance-based tests, to
estimate aerobic capacity as measured during cardiopulmonary exercise testing.
This has not yet been investigated in patients opting for elective major
intra-abdominal surgery, while accurate assessment of aerobic capacity in
patients opting for major intra-abdominal surgery is crucial for identifying
high-risk patients with a low aerobic capacity, as these patients might benefit
from prehabilitation to decrease postoperative health- and functioning-related
problems. Easy-to-perform performance-based aerobic capacity tests (steep ramp
test and 3-minute step test) might thus be cost-efficient alternatives for more
expensive and complicated laboratory aerobic capacity tests (cardiopulmonary
exercise testing). These alternative tests are readily implementable in
clinical oncology practice and can be invaluable for preoperative screening to
guide individual patient management for the purpose of improving postoperative
outcomes and prognosis.
Study objective
We aim to determine the validity of the steep ramp test as practical
performance-based aerobic capacity test in patients undergoing elective
colorectal resection by correlating the tests* scores with the ventilatory
anaerobic threshold and oxygen uptake at peak exercise attained during maximal
cardiopulmonary exercise testing on a cycle ergometer as gold standard test.
Study design
Cross-sectional study design. All patients will preoperatively perform the
steep ramp test as part of usual care (regular hospital visit), whereafter only
study participants will perform cardiopulmonary exercise testing in the context
of the study (no extra study visit).
Study burden and risks
There will be no direct benefits for patients participating in this study.
Patients gain insight in their physical fitness and as part of usual care will
receive preoperative advice after the last study procedure about the importance
of preoperative physical fitness and physical activity in relation to the risk
for morbidity and recovery of physical functioning postoperatively. Moreover,
in an extension of their regular care visit (preoperative assessment of
physical fitness) of one hour at maximum, participants help to optimize
perioperative care for future patients. Risks associated with participation are
considered negligible. Exercise testing will be performed under controlled
conditions and under the guidance of specifically trained employees and under
supervision of a sport physician. All non-usual care measurements are
non-invasive. Nevertheless, we realize that participation might be a burden for
every patient.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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).
Design
Recruitment
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In other registers
Register | ID |
---|---|
CCMO | NL69473.068.19 |