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临床试验/NCT03667183
NCT03667183已完成不适用

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

Universidad Pablo de Olavide0 个研究点目标入组 15 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 1) have other diagnoses of mental illness or
  • 2) consumption of narcotic toxins

结局指标

主要结局

Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).

时间窗: 3 times (week 0, week 10, week 20).

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.

Changes in the quality of life - KIDSCREEN-27.

时间窗: 3 times (week 0, week 10, week 20).

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.

Changes in perceived physical fitness - The International Fitness Scale (IFIS).

时间窗: 3 times (week 0, week 10, week 20).

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".

Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S

时间窗: 3 times (week 0, week 10, week 20).

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.

Changes in energy expenditure - SenseWear Mini (SWM).

时间窗: 3 times (week 0, week 10, week 20).

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.

Changes in body composition - InBody 770 (Body Composition Analyzer).

时间窗: 3 times (week 0, week 10, week 20).

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).

Changes in body perception - The Contour Drawing Rating Scale (CDRS).

时间窗: 3 times (week 0, week 10, week 20).

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.

Changes in physical fitness - ALPHA-Fitness Battery.

时间窗: 3 times (week 0, week 10, week 20).

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).

次要结局

  • Changes in blood parameters measured in g/dL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in mg/dL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in μUI/mL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in 10^3/μL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in %(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in fL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in μg/dL(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in mmol/L.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in ng/dL(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in mUI/mL.(3 times (week 0, week 10, week 20).)
  • Changes in blood parameters measured in pg/mL.(3 times (week 0, week 10, week 20).)

研究者

发起方
Universidad Pablo de Olavide
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sofía Mª Martínez Sánchez

Principal Investigator

Universidad Pablo de Olavide

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