Pilates Program in Female Adolescent With Eating Disorders

Study Overview
=================
Brief Summary
-----------------
Physical exercise helps patients with eating disorders by improving their physical fitness, quality of life and other specific variables of this pathology. Pilates has a beneficial effect both physically and mentally on healthy population and other diseases. In patients with eating disorder, Pilates will improve psychic aspects and their physical condition. For all these reasons, the affectation of psychological symptoms will decrease and the quality of life will improve.

Official Title
-----------------
Levels of Body Composition, Energy Expenditure, Physical Fitness and Quality of Life in Adolescents With Eating Disorders: Effect of a Pilates Program

Conditions
-----------------
Eating Disorder, Female Adolescents

Intervention / Treatment
-----------------
* Other: Pilates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) clinical diagnosis of EDs in the aforementioned hospital; 2) aged from 10 to 17 years old; 3) written informed consent by the patients and their legal guardians Exclusion Criteria: 1) have other diagnoses of mental illness or 2) consumption of narcotic toxins

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates Group<br>Female adolescents with eating disorders who receive Pilates for 10 weeks. | Other: Pilates<br>* Specific postures in movement according to Pilates guidelines.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3). | EDI-3 (Garner, 2004) is a self-report questionnaire that assesses the presence of eating disorders. The EDI-3 is composed of 91 items, organized into 12 main scales: 3 specific scales of eating behavior disorders (Drive for Thinness, DT; Bulimia, B; Body Dissatisfaction, BD) and 9 general psychological scales that are highly relevant, but not specific to eating disorders (Low Self-Esteem, LSE; Personal Alienation, PA; Interpersonal Insecurity, II; Interpersonal Alienation, IA; Interoceptive Deficits, ID; Emotional Dysregulation, ED; Perfectionism, P; Asceticism, A; Maturity Fears, MF). It also provides 6 composite scores: a specific one of the ED and 5 indices of integrative psychological constructs. The format of six-point Likert-scale responses: always, usually, often, sometimes, rarely or never. The score is between 0 and 4 points. The higher the score, the greater the disorder. | 3 times (week 0, week 10, week 20). | 
| Changes in energy expenditure - SenseWear Mini (SWM). | SenseWear Mini is a multi-sensor activity monitor that combines tri-axial accelerometry with physiological measurements (skin temperature, heat flux and galvanic skin response) for the estimation of several activity parameters. The information of the different sensors, together with the personal characteristics of the participant (sex, age, height, body weight and the use of hands) is processed through proprietary algorithms of the SenseWear software to estimate the energy expenditure, intensity of physical activity and the number of steps on a minute-by-minute basis. | 3 times (week 0, week 10, week 20). | 
| Changes in body composition - InBody 770 (Body Composition Analyzer). | InBody 770 (Inbody Co., LTD, Seoul, Korea) to measure body composition through bioelectrical impedance analysis (BIA). Parameters evaluated: Weight (kg); Total Body Water (L); Protein (kg); Minerals (kg); Body Fat Mass (kg); Soft Lean Mass (kg); Fat Free Mass (kg); Skeletal Muscle Mass (kg); Body Mass Index (kg/m2); Percent Body Fat (%); Bone Mineral Contect (kg). | 3 times (week 0, week 10, week 20). | 
| Changes in physical fitness - ALPHA-Fitness Battery. | ALPHA-Fitness Battery (Assessing Levels of Physical Activity and Fitness) was developed to provide a set of valid, reliable, safe and feasible field tests, in order to assess the physical fitness related to health in children and adolescents, and thus be used in a consensual manner in the Public Health system of the different member states of the European Union. There are three versions of the ALPHA-Fitness battery slightly different depending on the time available for the administration of the tests. We used the extended ALPHA-Fitness Battery. This version of the battery includes handgrip strength, standing broad jump, 4x10 m shuttle run test and 20 m shuttle run test (Ruiz et al., 2011). | 3 times (week 0, week 10, week 20). | 
| Changes in body perception - The Contour Drawing Rating Scale (CDRS). | The Contour Drawing Rating Scale (CDRS) (Thompson & Gray, 1995) is a scale that evaluates the alterations of the body image. This instrument is a graphic scale, self-administered application, composed of nine female figures views from the front. The person is asked to indicate which figure represents their current body image (perceived body image) and what figure they would like to have (desired body image). The discrepancy between these two classifications represents a measure of body dissatisfaction. The degree of discrepancy varied between -8 and -1 for those who desire a thinner form and between 1 and 8 for those who desire a larger form. A score of 0 was interpreted as satisfaction with body image (Dion et al., 2015). On the other hand, the body image perception index is determined by the following formula: (Estimated size / Actual size) x 100, which would indicate over-estimation when the scores are greater than 100 and underestimation when they are less than 100. | 3 times (week 0, week 10, week 20). | 
| Changes in the quality of life - KIDSCREEN-27. | KIDSCREEN-27 is a self-administered questionnaire that assesses the health and subjective well-being of children and adolescents (between the ages of 8 and 18) (Ravens-Sieberer et al., 2007). This questionnaire is composed of five dimensions on the Rasch scale: physical well-being, psychological well-being, autonomy and parent relation, peers and social support and school environment. The responses were evaluated and analyzed according to standard algorithms. The recommended syntax steps were performed, including the transformation of Rasch person parameter estimates into Z values, obtaining scale scores as T values with mean scores (± SD) of 50 ± 10 that define normality for children and adolescents of 8-18 years in Europe. Higher scores indicate a higher HRQoL. | 3 times (week 0, week 10, week 20). | 
| Changes in perceived physical fitness - The International Fitness Scale (IFIS). | The International FItness Scale (IFIS) is a questionnaire that evaluates the physical fitness, of self-administered application, quickly and easily (Ortega et al., 2011). It consists of 5 items (general physical fitness, cardiorespiratory fitness, muscular strength, speed/agility and flexibility) and each with 5 possible Likert-scale responses: very poor, poor, average, good or  very good. | 3 times (week 0, week 10, week 20). | 
| Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S | Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S) (de la Vega et al., 2015) is a questionnaire slightly adapted from the original (Buysse, Reynolds C. F., Monk, Berman, & Kupfer, 1989) to evaluate the subjective perception of sleep quality in the adolescent population. It consists of 19 items that are grouped into 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score of each component ranges from 0 (no difficulty) to 3 (severe difficulty) and the sum of all gives a total score that ranges from 0-21. A high score indicates poor sleep quality and less than 5 is considered high quality. | 3 times (week 0, week 10, week 20). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood parameters measured in mg/dL. | The following blood parameters measured in mg/dL were analyzed: glucose; total cholesterol; triglycerides; prealbumins; transferrin; urea; creatinine; calcium; phosphorus; magnesium; potassium; creatinine kinase; testosterone. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in g/dL. | The following blood parameters measured in g/dL were analyzed: total proteins; albumins; hemoglobin; mean corpuscular hemoglobin concentration. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in 10^3/μL. | The following blood parameters measured in 10^3/μL were analyzed: platelets; red blood cells; leukocytes; lymphocytes; neutrophils; monocytes; basophils; eosinophils. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in % | The following blood parameters measured in % were analyzed: hematocrit; red blood cell dispersion; transferrin saturation index. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in fL. | The following blood parameter measured in fL were analyzed: mean corpuscular volume. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in μg/dL | The following blood parameter measured in μg/dL were analyzed: iron. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in mmol/L. | The following blood parameter measured in mmol/L were analyzed: sodium. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in ng/dL | The following blood parameters measured in ng/dL were analyzed: ferritin; vitamin D; thyroxine; prolactin. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in μUI/mL. | The following blood parameter measured in μUI/mL were analyzed: thyrotropin. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in mUI/mL. | The following blood parameters measured in mUI/mL were analyzed: follitropin; lutropin. | 3 times (week 0, week 10, week 20). | 
| Changes in blood parameters measured in pg/mL. | The following blood parameters measured in pg/mL were analyzed: estradiol. | 3 times (week 0, week 10, week 20). |