The main objective is to study to separate patients who benefit from training, from patients who do not benefit from training and identify factors that impede training capability. Secondary objective if training leads to change of aerobic fitness (…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the analysis of patients who improve from training
compared to patients who do not improve from training. Variables that will be
checked are: initial fitness, BMI and age.
Secondary outcome
Secondary endpoints are:
- the change in VO2 at the ventilatory anaerobic threshold (VAT) after the (on
average) 6-weeks training program.
- program feasibility (recruitment rate, adherence, completion rate, drop-out
rate, attrition rate, and adverse events).
- the (preliminary) effect of the program on other cardiopulmonary exercise
testing (CPET) values, e.g., VO2 peak, oxygen uptake efficiency slope, and
response profiles.
- Postoperative events will be compared in relation to the subgroup analysis of
patients benefiting from training or not.
Background summary
An aneurysm of the abdominal aorta (AAA) is a potentially life-threatening
condition. Growth control and preventive surgery are important. It is proven
safe to train patients with an AAA (1-4).
Hypothesis: Training of patients awaiting their surgery for an AAA improves
preoperative aerobic fitness. Some patients will benefit more from these
training sessions than other patients.
Study objective
The main objective is to study to separate patients who benefit from training,
from patients who do not benefit from training and identify factors that impede
training capability. Secondary objective if training leads to change of aerobic
fitness (CoF) in AAA patients after supervised training with a patient-specific
training program. Feasibility of the study will be evaluated as well.
Study design
This is an intervention study. Patients, elected and fit for AAA surgery, are
included in this study. After inclusion, patients* socio-economic and personal
characteristics are collected in a questionnaire, as well as their
comorbidities (frailty-score, daily activities, ASA-score, dietary habits). All
included patients will train at home under the remote supervision of a
specialist in sports medicine and a physical therapist, using home monitoring
by means of the Luscii app.
Intervention
Patients with informed consent (IC) for this study must fill out a
questionnaire, with the assistance of a research nurse and perform a
cardiopulmonary exercise test (CPET). Patients unfit for training will be
excluded. This is evaluated by the cardiologist. Subjects fit for training
start with home monitoring (pulse oximeter and sphygmomanometer) under the
remote supervision of a physical therapist. Before and after three-to-nine-week
(on average six weeks) training, subjects are evaluated by a specialist in
sports medicine, to evaluate change of aerobic fitness with a CPET. All
patients, fit and unfit for training, will be followed until three months
postoperative.
Study burden and risks
Patients will be asked to fill out a questionnaire with a research nurse and
visit a cardiologist and a specialist in sports medicine preceding their
training. During their three-to-nine weeks awaiting surgery, patients will be
asked to train. This will be tiresome but rewarding; we expect to accomplish an
increase in condition. The elderly seems capable of performing home monitoring.
The extra energy and proteins necessary for the training will be substituted
with extra FortiFit. Apart from the extra consultations and the training the
patient will not undergo extra laboratory tests other than necessary for
regular AAA surgery.
The risks are minor, for it has been proven safe to train patients indicated
for elective AAA surgery in advance, (1-4, 6). Still, we wish to monitor at
home, and training is prohibited outside office hours. This enables the
research team to educate patients in health related issues (heart rate
recovery) and virtual hospital contact, earlier described as a Surgery School
(7). Furthermore, it is expected that patients are encouraged by the virtual
feedback.
Risk benefit analysis: the risks of causing harm are small, because patients
will be physically evaluated before training starts. The benefits may be
substantial for preparation improves outcome, patients will have been taught to
train, and home monitoring improves extramural communication and ease hospital
capacity issues.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1) Age 18 years or older
2) Diagnosed with an aneurysm of the abdominal aorta
3) Indication for a vascular intervention to prevent spontaneous rupture
4) Signed informed consent
5) Proven fit for training with a cardiopulmonary exercise test (CPET)
Exclusion criteria
- Patients with an acute indication for surgery (symptomatic or ruptured AAAs)
- Patients with an indication for priority surgery (semi-elective; within three
weeks)
- Patients with tissue disorders (e.g. Marfan or other).
- Patients for whom it is unsafe to train (high RR > 200mmHg, arrhytthmogenic
cardiomyopathy, or electrical abnormalities).
- Patients unable to understand the objectives or the devices of this study.
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 | NL82992.042.23 |