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
About this trial
This is an interventional supportive care trial for Eating Disorder
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
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
NCT ID
NCT03667183
First Posted
September 5, 2018
Last Updated
September 10, 2018
Sponsor
Universidad Pablo de Olavide
Collaborators
Complejo Hospitalario Universitario de Huelva
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
Learn more about this trial
Pilates Program in Female Adolescent With Eating Disorders
We'll reach out to this number within 24 hrs