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Pilates Program in Female Adolescent With Eating Disorders (PITCA)

Primary Purpose

Eating Disorder, Female Adolescents

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates
Sponsored by
Universidad Pablo de Olavide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eating Disorder

Eligibility Criteria

10 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pilates Group

    Arm Description

    Female adolescents with eating disorders who receive Pilates for 10 weeks.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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).
    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).
    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.
    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.
    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".
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    Changes in blood parameters measured in %
    The following blood parameters measured in % were analyzed: hematocrit; red blood cell dispersion; transferrin saturation index.
    Changes in blood parameters measured in fL.
    The following blood parameter measured in fL were analyzed: mean corpuscular volume.
    Changes in blood parameters measured in μg/dL
    The following blood parameter measured in μg/dL were analyzed: iron.
    Changes in blood parameters measured in mmol/L.
    The following blood parameter measured in mmol/L were analyzed: sodium.
    Changes in blood parameters measured in ng/dL
    The following blood parameters measured in ng/dL were analyzed: ferritin; vitamin D; thyroxine; prolactin.
    Changes in blood parameters measured in μUI/mL.
    The following blood parameter measured in μUI/mL were analyzed: thyrotropin.
    Changes in blood parameters measured in mUI/mL.
    The following blood parameters measured in mUI/mL were analyzed: follitropin; lutropin.
    Changes in blood parameters measured in pg/mL.
    The following blood parameters measured in pg/mL were analyzed: estradiol.

    Full Information

    First Posted
    September 5, 2018
    Last Updated
    September 10, 2018
    Sponsor
    Universidad Pablo de Olavide
    Collaborators
    Complejo Hospitalario Universitario de Huelva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03667183
    Brief Title
    Pilates Program in Female Adolescent With Eating Disorders
    Acronym
    PITCA
    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

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Pablo de Olavide
    Collaborators
    Complejo Hospitalario Universitario de Huelva

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorder, Female Adolescents

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilates Group
    Arm Type
    Experimental
    Arm Description
    Female adolescents with eating disorders who receive Pilates for 10 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Pilates
    Intervention Description
    Specific postures in movement according to Pilates guidelines.
    Primary Outcome Measure Information:
    Title
    Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in energy expenditure - SenseWear Mini (SWM).
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in body composition - InBody 770 (Body Composition Analyzer).
    Description
    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).
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in physical fitness - ALPHA-Fitness Battery.
    Description
    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).
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in body perception - The Contour Drawing Rating Scale (CDRS).
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in the quality of life - KIDSCREEN-27.
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in perceived physical fitness - The International Fitness Scale (IFIS).
    Description
    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".
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Secondary Outcome Measure Information:
    Title
    Changes in blood parameters measured in mg/dL.
    Description
    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.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in g/dL.
    Description
    The following blood parameters measured in g/dL were analyzed: total proteins; albumins; hemoglobin; mean corpuscular hemoglobin concentration.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in 10^3/μL.
    Description
    The following blood parameters measured in 10^3/μL were analyzed: platelets; red blood cells; leukocytes; lymphocytes; neutrophils; monocytes; basophils; eosinophils.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in %
    Description
    The following blood parameters measured in % were analyzed: hematocrit; red blood cell dispersion; transferrin saturation index.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in fL.
    Description
    The following blood parameter measured in fL were analyzed: mean corpuscular volume.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in μg/dL
    Description
    The following blood parameter measured in μg/dL were analyzed: iron.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in mmol/L.
    Description
    The following blood parameter measured in mmol/L were analyzed: sodium.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in ng/dL
    Description
    The following blood parameters measured in ng/dL were analyzed: ferritin; vitamin D; thyroxine; prolactin.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in μUI/mL.
    Description
    The following blood parameter measured in μUI/mL were analyzed: thyrotropin.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in mUI/mL.
    Description
    The following blood parameters measured in mUI/mL were analyzed: follitropin; lutropin.
    Time Frame
    3 times (week 0, week 10, week 20).
    Title
    Changes in blood parameters measured in pg/mL.
    Description
    The following blood parameters measured in pg/mL were analyzed: estradiol.
    Time Frame
    3 times (week 0, week 10, week 20).

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Garner D. Eating Disorder Inventory-3: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 2004.
    Results Reference
    background
    PubMed Identifier
    20961915
    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.
    Results Reference
    background
    PubMed Identifier
    7722852
    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.
    Results Reference
    background
    PubMed Identifier
    25931646
    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.
    Results Reference
    background
    PubMed Identifier
    17668292
    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.
    Results Reference
    background
    PubMed Identifier
    21441238
    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.
    Results Reference
    background
    PubMed Identifier
    26653055
    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.
    Results Reference
    background
    PubMed Identifier
    2748771
    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.
    Results Reference
    background

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    Pilates Program in Female Adolescent With Eating Disorders

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