The screening period starts once a patient has provided written informed consent to
participate in the study and ends on the day of exercise initiation. Screening
assessments have to be done within 28 days prior to exercise initiation. The informed
consent will adhere to IRB/ERC requirements, applicable laws and regulations. After the
sign of an informed consensus, patients will be assigned to a specific exercise program.
The first series of patients will be assigned to the Acute Exercise Program (AEP group),
the second series to the Chronic Exercise Program (CEP group). The protocol will be
implemented in the time between diagnosis and surgical intervention without any delay in
the therapeutic pathway.
Basal evaluation: patient's life style will be investigated using the short version of
Physical Activity Questionnaire (Italian version) and MeDiet questionnaire. Age, weight
and eight will be registered for all patients. The Lean Body Mass will be measured by
Dual Energy X-ray Absorptiometry (DEXA). A cardiorespiratory test will be performed to
calculate an appropriate exercise intensity and subsequently the Six Minutes WalkingTest
and the Comfortable Walking Speed test will be run before exercise protocol. In the CEP
group the DEXA and the walking tests will be repeated after the end of exercise program.
Exercise prescription: the physical exercise consists in walking at a brisk pace. In
order to produce a constant metabolic stress in patients with different aerobic power,
walking intensity will be prescribed in accordance with the method of the Heart Rate
Reserve (HRR), ie difference between resting heart rate (HR-resting) and the heart rate
corresponding to muscle's maximal oxygen uptake (HR-max). This prescribing method is
based on the linear relationship between heart rate reserve and muscle workload
calculated as a percentage of the difference between resting and maximum muscle oxygen
consumption (VO2R%). The training intensity will be set to the 30% HRR, the lowest
intensity that produces a training effect. To minimize the impact of the research
protocol on the patient's therapeutic path, the investigators refrain from the execution
of a Cardio Pulmonary Exercise Test and therefore opted for calculating the HR-max using
the ACSM formula. Given the entry criteria of this study the investigators believe this
choice will minimally affect the exercise-dose prescription and study results.
Acute Exercise Protocol (AEP): The acute program consists in a single walking session on
a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up
at the patient's self selected comfortable speed. On the ending of warm up, treadmill
speed will be increased until reaching target HRR zone. Then the treadmill speed will be
maintained stable throughout the exercise session. Cardiac workload will be monitored by
a Sport-watch (Garmin Forerunner 35) and the walking biomechanics by a foot sensor
(Garmin Running Dynamic Pod Sensore).
Chronic Exercise Protocol (CEP): The chronic program consists in a walking session on a
treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week
for three weeks. The walking intensity will be defined during a treadmill test performed
before the beginning of the exercise program. Each exercise session will begin with a
10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm
up, patients will increase treadmill speed until reaching target HRR zone. Then the
treadmill speed will be maintained stable throughout the exercise session. The first
training session will be organized in hospital with supervision of research staff.
Cardiac workload will be monitored by a Sport-watch(Garmin Forerunner 35) and walking
biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Diet intervention: Modifications occurring during AEP strictly depend on the baseline
metabolic conditions. For this reason, patients must remain fasting for 4 hours before
the workout and avoid glucose rich foodies for 120 minutes after the end of exercise
session in CEP group. During the exercise session patients will have free access to water
only. All patients will complete a food diary during the study period.
