Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Autoimmune Diseases

Diabetes Mellitus

Arthritis

Anorexia

Anorexia Nervosa

Arthritis, Juvenile

Inflammatory Bowel Diseases

Intestinal Diseases

Joint Diseases

Gastrointestinal Diseases

Gastroenteritis

Signs and Symptoms, Digestive

Feeding and Eating Disorders

Mental Disorders

Psychotic Disorders

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Chronic Graft Versus Host Disease

Patients with juvenile idiopathic arthritis, type 1 diabete mellitus, inflammatory bowel diseases, anorexia nervosa, cancer survivor

Patients will be separated in different subgroups. Subgroups will be constituted according the disease status (i.e. 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.

indirect calorimetry

Lise LACLAUTRE

Etienne MERLIN

Justyna KANOLD

Daniel TERRAL

Stéphane ECHAUBARD

Nicolas KARON

Corinne BORDERON

Florentina IFSAN

Eric DORE

Isabelle PETIT

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.

Health and Exercise Response in Children With Chronic and Auto-immune Pathologies

Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.

Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children

muscle cross sectional area (mm2) evaluated by peripheral Quantitative Computed Tomography (pQCT)

fat mass (g.cm²) evaluated by Dual-energy X-ray absorptiometry

Percentage variation of time to task failure duration during isometric contraction between pathological and healthy children.

blood level of inflammation markers (IL-17)

blood level of inflammation markers (CRP)

blood level of inflammation markers (IL-6)

blood level of inflammation markers (TNF - a)

blood level of inflammation markers (IL-10a)

blood level of inflammation markers (INF)

blood level of inflammation markers (calprotectin)

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

INSERM CIC 1405

University Hospital, Clermont-Ferrand

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients will receive auricular needling for 4 weeks .

This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.

Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Smallintestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.

auricular needling

Bin He

Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It plays an important role in improving the quality of life among advanced cancer patients. Through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and KPS between the auricular needling treating group and control group before and after the treatment. Based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.

Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be randomly assigned to two groups. In the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment are given at the same time. In the control group, patient just receive conventional nutrition support and symptomatic treatment.

The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. Other observation index include weight, KPS, appetite and the expectation of patients.

The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia

The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4（poor appetite) to20（good appetite）.The score lower than 14 predicts a risk of 5% weight loss.

Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia.

The appetite improvement is used to indicates the patient's appetite.Method: Use a moving ruler about 10cm long, with one side marked with 10 scales, the two ends are "0" and "10" respectively, 0 means normal appetite, 10 scores indicate extreme aversion to food. When in use, the side with the scale should face away from the patient, and let the patient mark on the ruler.The corresponding position that can represent one's own desire for food, the position marked by the doctor according to the patient is its score, clinical evaluation is divided into "normal appetite/basically normal eaters", "3-5" with "0-2".

Divided into "mild anorexia", "6-8" into "moderate anorexia", \>8 into "severe anorexia"

Weight used to assess the appetite of patient.Body weight changes caused by factors such as body cavity effusion and edema were excluded. Improvement: weight gain \> 2kg,and maintained for more than 4 weeks. Stable: Weight gain or loss ≤ 2kg. Exacerbation: Weight loss \> 2kg.

Acupuncture treating expectation questionnaire used to assess patients' expectation for auricular needling.Higher scores indicate higher expectations.Possible scores range from 4（low expectations） to 20（high expectations).

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Patients will receive auricular needling for 4 weeks .

auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.

Auricular Needling Group

Control Group

Total

The mean age of these 55 participants was 65±11 (range, 31 to 80) years old.

Age, Categorical

Age, Continuous

15 males and 13 females in control group and 10 males and 17 females in ear acupuncture group .

Sex: Female, Male

Ethnicity (NIH/OMB)

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

Body weight

Fall off in 5 cases, fall off reason : active request exit in 1 case, disease progression can not complete treatment in 1 case, 3 cases of loss rate 8.3 %.

Hebin

Baseline

Treatment for 2 weeks

Treatment for 4 weeks

Stop treatment for 4 weeks

Patients will receive auricular needling for 4 weeks .

Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Health and Exercise Response in Children With Chronic and Auto-immune Pathologies	NCT03913962	Juvenile Idiopa... Diabetes Inflammatory Bo... Cancer Survivor Anorexia Nervos...	indirect calori...	6 Years - 18 Years	University Hospital, Clermont-Ferrand
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia	NCT02887586	Anorexia Nervos... Cancer	auricular needl...	18 Years - 80 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia	NCT02887586	Anorexia Nervos... Cancer	auricular needl...	18 Years - 80 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Spots Global Cancer Trial Database for anorexia nervosa