The main objective is to assess the central (cardiac function) and peripheral (skeletal muscle function) physiological adaptations in response to exercise prehabilitation.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in left and right ventricular function will be measured by exCMR
in rest, during progressive exercise, and recovery to assess the effect of the
preoperative physical exercise training program on cardiac function. The
difference in quadriceps phosphocreatine concentration (PCr), quadriceps
inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during
progressive exercise, and recovery rate will be measured by 31P-MRS to assess
the effect of the prehabilitation program on skeletal muscle function.
Secondary outcome
Not applicable.
Background summary
Surgery remains an important treatment modality in the treatment of
hepatopancreatobiliary (HPB) malignancies, but the physiological stress caused
by surgery is at the same time a challenge for the homeostasis of patients. A
patient*s preoperative aerobic capacity has been found to have a consistent
relation with postoperative outcomes in major abdominal surgery, with low
aerobic capacity being associated with a higher risk of postoperative morbidity
and mortality. Preoperative exercise prehabilitation programs can effectively
increase the ability of patients to cope with surgical-induced allostatic load,
by improving aerobic capacity, and functioning of the respiratory,
cardiovascular, and/or musculoskeletal systems. However, besides the effect of
exercise prehabilitation on physical fitness in terms of improvement of aerobic
capacity as measured by the cardiopulmonary exercise test (CPET), the exact
role of adaptations in cardiac and/or skeletal muscle function contributing to
the improvement in aerobic capacity is still unknown. Insight in the
physiological adaptations that lead to improvement in aerobic capacity after
prehabilitation in patients with low aerobic capacity will enable caregivers to
individually optimize the exercise program (e.g. by changing exercise
frequency, intensity, duration and type) and better explain the rationale and
effectiveness behind the short-term physical exercise training program to
patients.
Study objective
The main objective is to assess the central (cardiac function) and peripheral
(skeletal muscle function) physiological adaptations in response to exercise
prehabilitation.
Study design
This study is a single center prospective clinical trial with a one-group
pretest-posttest design. It will take place at the University Medical Center
Groningen (UMCG), the Netherlands. As part of standard care all patients
scheduled to undergo hepatic or pancreatic surgery for (suspected) HPB
malignancies at the UMCG are screened for low aerobic capacity, and subjected
to exercise prehabilitation in case of low aerobic capacity. In this study,
unfit patients are asked to undergo additional in-magnet exercise testing to
investigate the central and peripheral physiological adaptations in response to
exercise prehabilitation. In-magnet exercise test consisting of in vivo
exercise Cardiac Magnetic Resonance (exCMR) imaging and 31P-Magnetic Resonance
Spectroscopy (31P-MRS) during exercise testing in a MR-compatible ergometer,
before and after the 4-week prehabilitation program.
Study burden and risks
The intervention consists of two extra hospital visits. During these visits the
in-magnet exercise tests (exCMR and 31P-MRS) will be performed. Patients will
perform an exCMR and 31P-MRS before and again after the exercise
prehabilitation program. The in-magnet exercise test can lead to physical
discomfort, due to an uncomfortable feeling while cycling on an ergometer
whilst laying supine in the MRI. Before the in-magnet exercise test, a CPET in
a controlled environment (continuous 12-lead electrocardiography registration
and under supervision of a sports physician) is performed and therefore the
in-magnet exercise test can be safely performed when the CPET does not show
contra-indications for exercise. The imaging consisting of exCMR and 31P-MRS
has previously been shown to be safe and is already widely used in different
studies. Patients are not exposed to any radiation and/or contrast agents.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- VO2 at the ventilatory anaerobic threshold (VAT) <=13 ml/kg/min and/or VO2peak
<=18 ml/kg/min, as determined during the baseline CPET;
- More than 18 years of age;
- Scheduled for elective liver- or pancreatic resection at the UMCG;
- Willing to participate in the home-based bimodal prehabilitation program;
- Has given consent to participate in the study
Exclusion criteria
- Patients requiring acute (emergency) surgery;
- Patients not capable of cycling on a cycle ergometer;
- Patients with contraindications to physical exercise training;
- Patients receiving neoadjuvant chemotherapy
- Contraindications for exCMR (e.g., claustrophobia, implanted cardiac devices)
- Atrial fibrillation or other significant arrhythmia during the exCMR and
31P-MRS procedures;
- Body weight >140 kg;
- Body length > 190cm
- History of myocardial infarction, percutaneous coronary intervention or
coronary artery bypass graft <3 months or untreated severe obstructive coronary
artery stenosis;
- More than moderate left-sided valve disease;
- Complex congenital heart disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83611.042.23 |