Diabetes Clinical Trial
Official title:
Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.
The aim of the present project is to assess the effects of the chronic diseases and their
associated treatments chronic paediatric diseases (CPD), to further understand their impact
on physical fitness for public health perspectives. This is an innovative approach in the
treatment of chronic paediatric diseases . This project should yield results that help
improving treatments for children and adolescents with chronic paediatric diseases throughout
physical activity as therapy, reduced pain, fatigue and inflammation, and improvement in
physical fitness and life quality. The originality and novelty of this project is to combine
architectural, functional and metabolic components of skeletal muscle to further understand
the impact of chronic paediatric diseases as a function of treatment, disease activity and
maturation status (prepubertal, pubertal or post pubertal).
This study will aim at assessing muscular function (force production capacity and
fatigability) in specific or ecologic situations so as to get information about muscle
functioning on isolated muscle group (here knee extensors) or during whole body exercise.
Moreover, results arising from muscle architecture or quality will allow understanding the
decrease in strength or endurance reported in the literature. The data collected will allow
us to further understand the impact of the disease on structural, functional and metabolic
parameters. Finally, the understanding of these alterations will provide information enabling
to establish recommendations in physical activity (PA) to reduce or even counter the effect
of the chronic inflammation and prevent at long-term overweight and cardiovascular risks.
The long-term objective is to contribute establishing recommendations or guidelines for
prescribing physical activity during medical therapy. Values obtained in pathological
children will be compared to those of control children matched for gender and maturation.
Patients will be separated in different subgroups. Subgroups will be constituted according
the disease status (active vs inactive) to assess the impact of the pathology on physical
fitness and according to treatments to assess the effect of treatment on physical fitness.
Patients will perform physical tests to provide information about their physical fitness
(body composition, metabolic flexibility, muscle strength and fatigue, bone mineral density),
which will be compared to age- and gender-matched healthy controls. Patients will also
complete blood tests to provide information about their inflammatory state to best understand
physiological disorders and allow a better classification of the disease status.
1. Metabolic flexibility assessment
After sitting quietly for 20 min, subjects will perform a graded exercise test to
volitional fatigue on an electromagnetically braked cycle ergometer with continuous gas
collection and heart rate monitoring. In all subjects, when the Respiratory Exchange
Ratio will be ≥1.00, indicating zero fat oxidation, the work rate will be increased by
the same increments at 1-min intervals until volitional fatigue. O2 consumption (VO2)
peak will be considered maximal when the Respiratory Exchange Ratio will be ≥1.05 and
the subject will achieve his age-predicted maximal heart rate [heart rate maximum: (220
- age)]. Indirect calorimetry, as will be used in this study, is the standard method to
quantify substrate oxidation rates at rest and during exercise. O2 consumption (VO2) and
CO2 production (VCO2) will be averaged over the final 1 min of each work rate, and the
results of this test will be used to calculate fat oxidation over a wide range of
exercise intensities for each subject with the equations:
Lipids (mg.min-1) = 1.6946 x VO2 - 1.7012 x VCO2 and CHO (mg.min-1) = 4.585 VCO2 -
3.2255 VO2.
2. Muscle architecture Subjects will be lied on a massage table, muscle relaxed. Ultrasound
will be used on vastus lateralis (VL), vastus medialis (VM) and rectus femoris (RF) to
assess muscle architecture. The muscle belly will be measured according to Surface
ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) recommendations.
Muscle thickness (the distance between superior and inferior aponeurosis) and fascicule
angle (the angle formed by muscle fascicule and the inferior aponeurosis) will be
measured for each muscle.
3. Muscle quality Subjects will sit on an adjustable seat. The right tight will be placed
into the antenna of the peripheral quantitative tomography, so that the femoral condyles
are aligned with the laser. An antero-posterior scout-view will be performed to detect
junction between tibial tray and the femur, which matched with the starting position of
the measurement. Then, a measure will be performed at 40% of the length between the
greater trochanter and the mid-patella of the right leg. Muscle cross sectional area
(CSA) and intramuscular adipose tissue (IMAT) will be assessed. The measurements will be
performed by the same investigator to avoid any inter-individual bias.
4. Muscle function
o Vertical jump height: Subjects will have to perform a series of vertical jumps.
Subjects will perform two squat jumps (SJ) and two counter movements jumps (CMJ) using
an OptoJump following standardised guidelines. For SJ, subjects will have to flex their
knee at 90° with the hand on the hip to avoid any counter movements induced by the upper
limbs. Subjects will have to maintain the position for 3-s. The guidelines for CMJ will
be similar, but without short break between standing and flexing positions. For both
exercises, subjects will have to jump as high as possible. Vertical jump height will be
calculated according the formula where T is time flight duration and g the acceleration
of 9.81 m.s-2 of gravity.
o Maximal voluntary strength: Subjects will sit on an isokinetic dynamometer with a hip
angle of 40° (0°= standing position). Upper body will be strapped on the chair back and
subjects will have to grip the chair to avoid any counter-movements. Their right ankle
will be strapped and connected to a force sensor. After a standardised warm up
consisting of repeating isometric contractions at increasing intensities, patients will
have to perform maximal voluntary isometric contractions (MVIC). MVIC will be performed
at different randomized joint angles (29°, 66°, 76°, 87° and 103° [0° = full extension])
to determine the optimal angle producing maximal strength. Two measurements will be
performed at each angle to check the reproducibility. A third trial will be performed if
the difference between both measurements is higher than 5%. Subjects will be vigorously
encouraged to produce maximal voluntary strength during isometric contractions. Root
Mean Square (RMS) values will be calculated from the electromyographic (EMG) activity
recorded on VL, VM and RF.
5. Muscle fatigue Muscle fatigue will be assessed with the same method as previously
described. For this test, patients will have to maintain a force level corresponding to
50% MVIC to avoid any knee pain. The exercise will be stopped when subjects will be
unable to maintain the force level more than 3-s despite vigorous encouragements. Time
duration to task failure will be measured.
6. Bone micro-architecture Bone micro-architecture will be assessed through bone mineral
density, trabecular and cortical density. This measurement will be performed in the same
time that muscle quality assessment by pQCT. Patients will be placed in the same
position. Two measurement will be done using pQCT at 20% and 40% of the tight.
Micro-architectural parameters (trabecular and cortical density) will be calculated.
7. Body composition Body composition will be assessed by Dual-energy X-ray absorptiometry.
Fat and fat-free mass, and bone density will be measured for the whole body and segments
(arm, leg and trunk).
8. Biology Blood samples will be drawn once a year for patients and once for controls.
Blood samples will allow to assess NFS (blood formul numeration), ionogramme, CRPus, VS,
total bilirubin, ASAT, ALAT, GGT, PAL, glycaemia, total cholesterol -HDL-LDL,
triglycerid, TSH, T4, adiponectin et leptin. Lipidomic, Cytokines and their receptors,
calgranulins and MicroARNs will be also assessed thereafter.
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