Skip to main content
OpenTrials
Completed

NCT Number: NCT03667183

Pilates Program in Female Adolescent With Eating Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilates

Other

Specific postures in movement according to Pilates guidelines.

Primary outcomes

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

    Time frame: 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.

  2. Changes in energy expenditure - SenseWear Mini (SWM).

    Time frame: 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.

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

    Time frame: 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).

  4. Changes in physical fitness - ALPHA-Fitness Battery.

    Time frame: 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).

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

    Time frame: 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.

  6. Changes in the quality of life - KIDSCREEN-27.

    Time frame: 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.

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

    Time frame: 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".

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

    Time frame: 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.

Secondary outcomes

  1. Changes in blood parameters measured in mg/dL.

    Time frame: 3 times (week 0, week 10, week 20).

    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.

  2. Changes in blood parameters measured in g/dL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in g/dL were analyzed: total proteins; albumins; hemoglobin; mean corpuscular hemoglobin concentration.

  3. Changes in blood parameters measured in 10^3/μL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in 10^3/μL were analyzed: platelets; red blood cells; leukocytes; lymphocytes; neutrophils; monocytes; basophils; eosinophils.

  4. Changes in blood parameters measured in %

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in % were analyzed: hematocrit; red blood cell dispersion; transferrin saturation index.

  5. Changes in blood parameters measured in fL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameter measured in fL were analyzed: mean corpuscular volume.

  6. Changes in blood parameters measured in μg/dL

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameter measured in μg/dL were analyzed: iron.

  7. Changes in blood parameters measured in mmol/L.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameter measured in mmol/L were analyzed: sodium.

  8. Changes in blood parameters measured in ng/dL

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in ng/dL were analyzed: ferritin; vitamin D; thyroxine; prolactin.

  9. Changes in blood parameters measured in μUI/mL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameter measured in μUI/mL were analyzed: thyrotropin.

  10. Changes in blood parameters measured in mUI/mL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in mUI/mL were analyzed: follitropin; lutropin.

  11. Changes in blood parameters measured in pg/mL.

    Time frame: 3 times (week 0, week 10, week 20).

    The following blood parameters measured in pg/mL were analyzed: estradiol.

Sponsors and collaborators

Lead sponsor

Universidad Pablo de Olavide

Other

Collaborators

  • Complejo Hospitalario Universitario de Huelva

Registry information

Official study title

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

Acronym: PITCA

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 12, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.