Clinical trial NCT03667183: Pilates Program in Female Adolescent With Eating Disorders
Official title: Levels of Body Composition, Energy Expenditure, Physical Fitness and Quality of Life in Adolescents With Eating Disorders: Effect of a Pilates Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Female Adolescents
Lead sponsor: Universidad Pablo de Olavide
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Huelva
First posted: 2018-09-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in energy expenditure - SenseWear Mini (SWM).
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in body composition - InBody 770 (Body Composition Analyzer).
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in physical fitness - ALPHA-Fitness Battery.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in body perception - The Contour Drawing Rating Scale (CDRS).
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in the quality of life - KIDSCREEN-27.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in perceived physical fitness - The International Fitness Scale (IFIS).
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S
timeFrame: 3 times (week 0, week 10, week 20).
Secondary outcomes:
measure: Changes in blood parameters measured in mg/dL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in g/dL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in 10^3/μL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in %
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in fL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in μg/dL
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in mmol/L.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in ng/dL
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in μUI/mL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in mUI/mL.
timeFrame: 3 times (week 0, week 10, week 20).
measure: Changes in blood parameters measured in pg/mL.
timeFrame: 3 times (week 0, week 10, week 20).
Other outcomes:
Locations:
Study officials:
References:
citation: Garner D. Eating Disorder Inventory-3: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 2004.
citation: Ruiz JR, Castro-Pinero J, Espana-Romero V, Artero EG, Ortega FB, Cuenca MM, Jimenez-Pavon D, Chillon P, Girela-Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. Field-based fitness assessment in young people: the ALPHA health-related fitness test battery for children and adolescents. Br J Sports Med. 2011 May;45(6):518-24. doi: 10.1136/bjsm.2010.075341. Epub 2010 Oct 19.
citation: Thompson MA, Gray JJ. Development and validation of a new body-image assessment scale. J Pers Assess. 1995 Apr;64(2):258-69. doi: 10.1207/s15327752jpa6402_6.
citation: Dion J, Blackburn ME, Auclair J, Laberge L, Veillette S, Gaudreault M, Vachon P, Perron M, Touchette E. Development and aetiology of body dissatisfaction in adolescent boys and girls. Int J Adolesc Youth. 2015 Apr 3;20(2):151-166. doi: 10.1080/02673843.2014.985320. Epub 2014 Dec 3.
citation: Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007 Oct;16(8):1347-56. doi: 10.1007/s11136-007-9240-2. Epub 2007 Aug 1.
citation: Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
citation: de la Vega R, Tome-Pires C, Sole E, Racine M, Castarlenas E, Jensen MP, Miro J. The Pittsburgh Sleep Quality Index: Validity and factor structure in young people. Psychol Assess. 2015 Dec;27(4):e22-7. doi: 10.1037/pas0000128.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.