<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03831867</url>
  </required_header>
  <id_info>
    <org_study_id>NGonzalez</org_study_id>
    <nct_id>NCT03831867</nct_id>
  </id_info>
  <brief_title>Changes in Sagittal Spine Posture and Flexibility on Adolescents</brief_title>
  <official_title>Effectiveness of Pilates on Sagittal Spine Posture, Flexibility, Back Pain, Quality of Life and Anthropometrics Variables on Adolescents: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several research show a high prevalence of spinal misalignments and a lack of stability of&#xD;
      the spine in the adolescent population. In addition, back pain in adolescents is correlated&#xD;
      with a longer time spent in sedentary activities, less time of physical activity, higher BMI,&#xD;
      body fat percentage and / or the waist-hip index.&#xD;
&#xD;
      Therefore, the main aim of this project were assess the effect of a 10-minute Pilates program&#xD;
      carried out in the final part of the Physical Education sessions for 4.5 months and 9 months&#xD;
      on back pain, quality of life, sagittal spine curvature, hamstring extensibility, BMI, body&#xD;
      fat percentage and the waist-hip index.&#xD;
&#xD;
      The present research will be elaborated by a quasi-experimental design, with experimental&#xD;
      group (GE) and control group (CG); with pre-test, intermediate and post-test.&#xD;
&#xD;
      The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not present&#xD;
      any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of&#xD;
      spinal pathologies or with previous treatment; c) be active in the sessions of Physical&#xD;
      Education.&#xD;
&#xD;
      It was assessed back pain with Back Pain Survey in adolescents. Quality of life was assessed&#xD;
      through the Kidscreen-27 questionnaire. To assess the sagittal spinal curvatura (in several&#xD;
      positions) the Spinal Mouse System (Idiag, Fehraltdorf, Switzerland) was used.&#xD;
&#xD;
      The extensibility of hamstring muscle was assessed with seat and reach test, toe touch test&#xD;
      and active and passive straight leg raising test.&#xD;
&#xD;
      The sedentary lifestyle as well as the level of physical activity will be evaluated through&#xD;
      the Adolescent International Physical Activity Questionnaire (IPAQ).&#xD;
&#xD;
      The body mass index will be obtained by recording weight and height (BMI = Weight (kg) /&#xD;
      height (cm) 2).&#xD;
&#xD;
      The waist-hip ratio is the quotient between waist and hip circumferences, which is an&#xD;
      indirect marker of intra-abdominal obesity.&#xD;
&#xD;
      The intervention program consisted on performance of exercises of the Pilates Method during&#xD;
      the sessions of Physical Education, 32 weeks, two weekly sessions, 10 minutes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A history of back pain during adulthood is related to a history of back pain during&#xD;
      adolescence. Therefore, preventing back pain in adolescents helps to prevent their appearance&#xD;
      in adulthood. Sagittal spinal misalignments and stability of the spine are in connection with&#xD;
      back pain in adolescents. In addition, they influence on several spinal pathologies and&#xD;
      decrease the functional capacity and quality of life of adolescents.&#xD;
&#xD;
      Therefore, the objectives of the following project were: a) assess back pain in&#xD;
      schoolchildren and check their relationship with quality of life, sagittal spine curvature,&#xD;
      extensibility of the hamstring muscles, sedentary lifestyle, physical activity, BMI ,&#xD;
      percentage of body fat and the waist-hip index; b) measure the sagittal spinal curvature of&#xD;
      the schoolchildren, the quality of life and the prevalence of physical activity among&#xD;
      adolescents and check their relationship with the hamstring extensibility, sedentary&#xD;
      lifestyle, the BMI , percentage of body fat and the waist-hip index; c) analyze the effect of&#xD;
      a 10-minute Pilates program carried out in the final part of the Physical Education sessions&#xD;
      for 4.5 months and 9 months on back pain, quality of life, sagittal spinal curvatures, the&#xD;
      hamstring flexibility, the BMI, the percentage of body fat and the waist-hip index.&#xD;
&#xD;
      The present investigation will be elaborated by a quasi-experimental design, with&#xD;
      experimental group (GE) and control group (CG); with pre-test, intermediate and post-test,&#xD;
      with analysis of intra-group and inter-group measurements for each of the dependent variables&#xD;
      selected in the study.&#xD;
&#xD;
      The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not present&#xD;
      any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of&#xD;
      spinal pathologies or with previous treatment; c) be active in the sessions of Physical&#xD;
      Education.&#xD;
&#xD;
      It was assessed back pain with Back Pain Survey in adolescents. Quality of life was assessed&#xD;
      through the Kidscreen-27 questionnaire. To assess the sagittal spinal curvatura (in several&#xD;
      position) the Spinal Mouse System (Idiag, Fehraltdorf, Switzerland) was used.&#xD;
&#xD;
      The extensibility of hamstring muscle was assessed with seat and reach test, toe touch test&#xD;
      and active and passive straight leg raising test.&#xD;
&#xD;
      The sedentary lifestyle as well as the level of physical activity will be evaluated through&#xD;
      the Adolescent International Physical Activity Questionnaire (IPAQ).&#xD;
&#xD;
      The body mass index will be obtained by recording weight and height (BMI = Weight (kg) /&#xD;
      height (cm) 2).&#xD;
&#xD;
      The waist-hip ratio is the quotient between waist and hip circumferences, which is an&#xD;
      indirect marker of intra-abdominal obesity.&#xD;
&#xD;
      The intervention program consisted in the realization of exercises of the Pilates Method&#xD;
      during the sessions of Physical Education. The duration of the program will be 32 weeks, with&#xD;
      a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this&#xD;
      time the experimental group developed the intervention program with the Pilates Method and&#xD;
      the control group carried out their usual sessions of Physical Education . All students to be&#xD;
      taken into account in the research must have attended and conducted the practice at least 80%&#xD;
      of sessions. The program consisted of four Pilates exercises, planned with a&#xD;
      basic-intermediate level, gradually incorporating the Principles of the Pilates Method and&#xD;
      increasing the intensity of the exercises. Among these four exercises, two focus on the work&#xD;
      of the resistance of the flexor muscles of the trunk, one in the work of the resistance of&#xD;
      the trunk extensor musculature and another in the work of hamstring extensibility.The&#xD;
      exercises will be performed in cool down of the sessions of Physical Education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change Sagittal spinal curvature</measure>
    <time_frame>Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month</time_frame>
    <description>Sagittal spinal curvature is assess with the Spinal Mouse System. It is measure: angle of the dorsal and lumbar curve and pelvic tilt when standing, in self-correcting standing, in asthenic sitting, in maximum trunk flexion. knees flexed and extended; and maximum trunk flexion from standing. This is noninvasive technique. The result is register in grades.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Hamstring extensibility - active straight leg raising test.</measure>
    <time_frame>Change from Baseline hamstring extensibility at 4,5 month and at 9 month</time_frame>
    <description>The hamstring extensibility is assessed by active straight leg raising test. This is noninvasive technique. The result is register in grades. Higher values represent a better outcome. The range could be between 0 to 180º. Normal values: between 75 to 180º; Shortness type I: between 61 to 74º; and shortness type II; less than 60º. Shortness is mean that the subject have less hamstring extensibility than the normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Hamstring extensibility - passive straight leg raising test.</measure>
    <time_frame>Change from Baseline Hamstring extensibility at 4,5 month and at 9 month</time_frame>
    <description>The hamstring extensibility is assessed by passive straight leg raising test. This is noninvasive technique. The result is register in grades. Higher values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Back pain, physical activity and sedentary behaviour (questionnaire)</measure>
    <time_frame>Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month</time_frame>
    <description>Back pain, physical activity and sedentary behaviour is evaluated through the Back Pain Survey in adolescents. This questionnaire included questions about this three items.&#xD;
This survey is used to know the prevalence of back pain, physical activity and sedentary time.&#xD;
The survey do not includes a scale. The survey ask questions like: Did you have back pain last year that will hamper or limit activities at school or in their leisure time for more than 3 months? Yes/no ; Do you practice any sport in your free live? Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Quality of life: Kindscreem 27 questionnaire</measure>
    <time_frame>Change from Baseline Back pain, physical activity and sedentary behaviour at 4,5 month and at 9 month</time_frame>
    <description>Quality of life is assessed through the Kindscreem 27 questionnaire.&#xD;
To measure the quality of life related to health in adolescents with a total of 27 items assessed on the Likert Scale in the following dimensions: physical activity and health, psychological well-being, relationship with peers and autonomy, social support and peers, and the environment school. Categorizing:&#xD;
Extremely difficult 27 to 54;Moderate difficulty 55 to 81;No difficulty makes 82 to 135</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Body mass index</measure>
    <time_frame>Change from Baseline Body mass index at 4,5 month and at 9 month</time_frame>
    <description>The body mass index is obtained by recording weight and height. They will be measured with a 220k digital medical scale with height meter. The BMI will be calculated with the formula of the Quetelet Index (1869) (BMI = Weight (kg) / height (cm) 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Waist-hip ratio</measure>
    <time_frame>Change from Baseline Waist-hip ratio at 4,5 month and at 9 month</time_frame>
    <description>The waist-hip ratio is the quotient between waist and hip circumferences, which is an indirect marker of intra-abdominal obesity. This is noninvasive technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Hamstring extensibility Seat and Reach test</measure>
    <time_frame>Change from Baseline Hamstring extensibility at 4,5 month and at 9 month</time_frame>
    <description>The hamstring extensibility is assessed by seat and reach test. This is noninvasive test.&#xD;
The result is register in centimeters. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Hamstring extensibility Toe touch test</measure>
    <time_frame>Change from Baseline Hamstring extensibility at 4,5 month and at 9 month</time_frame>
    <description>The hamstring extensibility is assessed by toe touch test. This is noninvasive test.&#xD;
The result is register in centimetres. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Level of physical activity - Adolescent International Physical Activity Questionnaire (IPAQ).</measure>
    <time_frame>Change from Baseline Level of physical activity at 4,5 month and at 9 month</time_frame>
    <description>The level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).&#xD;
It is register and summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.The following values continue to be used for the analysis of IPAQ data: Walking=3.3METs (equivalent metabolic), Moderate PA (physical activity)=4.0METs (Metabolic equivalent) and Vigorous PA=8.0METs (Metabolic equivalent).&#xD;
Category 1 Low: Those individuals who not meet criteria for Categories 2 or 3. Category 2 Moderate: Total physical activity of at least 600 MET-minutes/week. Category 3 High: a) Total physical activity of at least 3000 MET-minutes/week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">286</enrollment>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Pilates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates</intervention_name>
    <description>The intervention program consisted in the realization of exercises of the Pilates Method. The duration of the program was 32 weeks, with a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this time the experimental group developed the intervention program with the Pilates Method.</description>
    <arm_group_label>Pilates</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be enrolled in Compulsory Secondary Education&#xD;
&#xD;
          -  be active in the sessions of Physical Education.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic&#xD;
             alteration&#xD;
&#xD;
          -  missing more than one session of the programme (91.66% attendance)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noelia G Gálvez, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCAM</affiliation>
  </overall_official>
  <reference>
    <citation>Peterson L, Haladay DE. Pilates-based exercise in the treatment of a patient with persistent low back pain following transforaminal lumbar interbody fusion. Physiother Theory Pract. 2020 Apr;36(4):542-549. doi: 10.1080/09593985.2018.1488905. Epub 2018 Jun 26.</citation>
    <PMID>29944036</PMID>
  </reference>
  <reference>
    <citation>Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.</citation>
    <PMID>29651872</PMID>
  </reference>
  <reference>
    <citation>Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.</citation>
    <PMID>29525763</PMID>
  </reference>
  <reference>
    <citation>Kibar S, Yardimci FO, Evcik D, Ay S, Alhan A, Manco M, Ergin ES. Can a pilates exercise program be effective on balance, flexibility and muscle endurance? A randomized controlled trial. J Sports Med Phys Fitness. 2016 Oct;56(10):1139-1146. Epub 2015 Oct 16.</citation>
    <PMID>26473443</PMID>
  </reference>
  <reference>
    <citation>Vaquero-Cristobal R, Lopez-Minarro PA, Alacid Carceles F, Esparza-Ros F. [THE EFFECTS OF THE PILATES METHOD ON HAMSTRING EXTENSIBILITY, PELVIC TILT AND TRUNK FLEXION]. Nutr Hosp. 2015 Nov 1;32(5):1967-86. doi: 10.3305/nh.2015.32.5.9678. Spanish.</citation>
    <PMID>26545650</PMID>
  </reference>
  <reference>
    <citation>Miranda IF, Souza C, Schneider AT, Chagas LC, Loss JF. Comparison of low back mobility and stability exercises from Pilates in non-specific low back pain: A study protocol of a randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:360-368. doi: 10.1016/j.ctcp.2017.12.005. Epub 2017 Dec 8.</citation>
    <PMID>29248397</PMID>
  </reference>
  <reference>
    <citation>Gonzalez-Galvez N, Marcos-Pardo PJ, Carrasco-Poyatos M. Functional improvements after a pilates program in adolescents with a history of back pain: A randomised controlled trial. Complement Ther Clin Pract. 2019 May;35:1-7. doi: 10.1016/j.ctcp.2019.01.006. Epub 2019 Jan 10.</citation>
    <PMID>31003644</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Noelia González-Gálvez</investigator_full_name>
    <investigator_title>PhD. Noelia González Gálvez</investigator_title>
  </responsible_party>
  <keyword>spine</keyword>
  <keyword>extensibility</keyword>
  <keyword>children</keyword>
  <keyword>health</keyword>
  <keyword>pilates</keyword>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <keyword>physical education</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831867
org study id: NGonzalez
nct id: NCT03831867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several research show a high prevalence of spinal misalignments and a lack of stability of
      the spine in the adolescent population. In addition, back pain in adolescents is correlated
      with a longer time spent in sedentary activities, less time of physical activity, higher BMI,
      body fat percentage and / or the waist-hip index.

      Therefore, the main aim of this project were assess the effect of a 10-minute Pilates program
      carried out in the final part of the Physical Education sessions for 4.5 months and 9 months
      on back pain, quality of life, sagittal spine curvature, hamstring extensibility, BMI, body
      fat percentage and the waist-hip index.

      The present research will be elaborated by a quasi-experimental design, with experimental
      group (GE) and control group (CG); with pre-test, intermediate and post-test.

      The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not present
      any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of
      spinal pathologies or with previous treatment; c) be active in the sessions of Physical
      Education.

      It was assessed back pain with Back Pain Survey in adolescents. Quality of life was assessed
      through the Kidscreen-27 questionnaire. To assess the sagittal spinal curvatura (in several
      positions) the Spinal Mouse System (Idiag, Fehraltdorf, Switzerland) was used.

      The extensibility of hamstring muscle was assessed with seat and reach test, toe touch test
      and active and passive straight leg raising test.

      The sedentary lifestyle as well as the level of physical activity will be evaluated through
      the Adolescent International Physical Activity Questionnaire (IPAQ).

      The body mass index will be obtained by recording weight and height (BMI = Weight (kg) /
      height (cm) 2).

      The waist-hip ratio is the quotient between waist and hip circumferences, which is an
      indirect marker of intra-abdominal obesity.

      The intervention program consisted on performance of exercises of the Pilates Method during
      the sessions of Physical Education, 32 weeks, two weekly sessions, 10 minutes.
A history of back pain during adulthood is related to a history of back pain during
      adolescence. Therefore, preventing back pain in adolescents helps to prevent their appearance
      in adulthood. Sagittal spinal misalignments and stability of the spine are in connection with
      back pain in adolescents. In addition, they influence on several spinal pathologies and
      decrease the functional capacity and quality of life of adolescents.

      Therefore, the objectives of the following project were: a) assess back pain in
      schoolchildren and check their relationship with quality of life, sagittal spine curvature,
      extensibility of the hamstring muscles, sedentary lifestyle, physical activity, BMI ,
      percentage of body fat and the waist-hip index; b) measure the sagittal spinal curvature of
      the schoolchildren, the quality of life and the prevalence of physical activity among
      adolescents and check their relationship with the hamstring extensibility, sedentary
      lifestyle, the BMI , percentage of body fat and the waist-hip index; c) analyze the effect of
      a 10-minute Pilates program carried out in the final part of the Physical Education sessions
      for 4.5 months and 9 months on back pain, quality of life, sagittal spinal curvatures, the
      hamstring flexibility, the BMI, the percentage of body fat and the waist-hip index.

      The present investigation will be elaborated by a quasi-experimental design, with
      experimental group (GE) and control group (CG); with pre-test, intermediate and post-test,
      with analysis of intra-group and inter-group measurements for each of the dependent variables
      selected in the study.

      The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not present
      any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of
      spinal pathologies or with previous treatment; c) be active in the sessions of Physical
      Education.

      It was assessed back pain with Back Pain Survey in adolescents. Quality of life was assessed
      through the Kidscreen-27 questionnaire. To assess the sagittal spinal curvatura (in several
      position) the Spinal Mouse System (Idiag, Fehraltdorf, Switzerland) was used.

      The extensibility of hamstring muscle was assessed with seat and reach test, toe touch test
      and active and passive straight leg raising test.

      The sedentary lifestyle as well as the level of physical activity will be evaluated through
      the Adolescent International Physical Activity Questionnaire (IPAQ).

      The body mass index will be obtained by recording weight and height (BMI = Weight (kg) /
      height (cm) 2).

      The waist-hip ratio is the quotient between waist and hip circumferences, which is an
      indirect marker of intra-abdominal obesity.

      The intervention program consisted in the realization of exercises of the Pilates Method
      during the sessions of Physical Education. The duration of the program will be 32 weeks, with
      a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this
      time the experimental group developed the intervention program with the Pilates Method and
      the control group carried out their usual sessions of Physical Education . All students to be
      taken into account in the research must have attended and conducted the practice at least 80%
      of sessions. The program consisted of four Pilates exercises, planned with a
      basic-intermediate level, gradually incorporating the Principles of the Pilates Method and
      increasing the intensity of the exercises. Among these four exercises, two focus on the work
      of the resistance of the flexor muscles of the trunk, one in the work of the resistance of
      the trunk extensor musculature and another in the work of hamstring extensibility.The
      exercises will be performed in cool down of the sessions of Physical Education.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change Sagittal spinal curvature
time frame: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month
description: Sagittal spinal curvature is assess with the Spinal Mouse System. It is measure: angle of the dorsal and lumbar curve and pelvic tilt when standing, in self-correcting standing, in asthenic sitting, in maximum trunk flexion. knees flexed and extended; and maximum trunk flexion from standing. This is noninvasive technique. The result is register in grades.
measure: Change Hamstring extensibility - active straight leg raising test.
time frame: Change from Baseline hamstring extensibility at 4,5 month and at 9 month
description: The hamstring extensibility is assessed by active straight leg raising test. This is noninvasive technique. The result is register in grades. Higher values represent a better outcome. The range could be between 0 to 180º. Normal values: between 75 to 180º; Shortness type I: between 61 to 74º; and shortness type II; less than 60º. Shortness is mean that the subject have less hamstring extensibility than the normal.
measure: Change Hamstring extensibility - passive straight leg raising test.
time frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
description: The hamstring extensibility is assessed by passive straight leg raising test. This is noninvasive technique. The result is register in grades. Higher values represent a better outcome.
measure: Change Back pain, physical activity and sedentary behaviour (questionnaire)
time frame: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month
description: Back pain, physical activity and sedentary behaviour is evaluated through the Back Pain Survey in adolescents. This questionnaire included questions about this three items.
This survey is used to know the prevalence of back pain, physical activity and sedentary time.
The survey do not includes a scale. The survey ask questions like: Did you have back pain last year that will hamper or limit activities at school or in their leisure time for more than 3 months? Yes/no ; Do you practice any sport in your free live? Yes/No
measure: Change Quality of life: Kindscreem 27 questionnaire
time frame: Change from Baseline Back pain, physical activity and sedentary behaviour at 4,5 month and at 9 month
description: Quality of life is assessed through the Kindscreem 27 questionnaire.
To measure the quality of life related to health in adolescents with a total of 27 items assessed on the Likert Scale in the following dimensions: physical activity and health, psychological well-being, relationship with peers and autonomy, social support and peers, and the environment school. Categorizing:
Extremely difficult 27 to 54;Moderate difficulty 55 to 81;No difficulty makes 82 to 135
measure: Change Body mass index
time frame: Change from Baseline Body mass index at 4,5 month and at 9 month
description: The body mass index is obtained by recording weight and height. They will be measured with a 220k digital medical scale with height meter. The BMI will be calculated with the formula of the Quetelet Index (1869) (BMI = Weight (kg) / height (cm) 2).
measure: Change Waist-hip ratio
time frame: Change from Baseline Waist-hip ratio at 4,5 month and at 9 month
description: The waist-hip ratio is the quotient between waist and hip circumferences, which is an indirect marker of intra-abdominal obesity. This is noninvasive technique.
measure: Change Hamstring extensibility Seat and Reach test
time frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
description: The hamstring extensibility is assessed by seat and reach test. This is noninvasive test.
The result is register in centimeters. Higher values represent a better outcome.
measure: Change Hamstring extensibility Toe touch test
time frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
description: The hamstring extensibility is assessed by toe touch test. This is noninvasive test.
The result is register in centimetres. Higher values represent a better outcome.
measure: Change Level of physical activity - Adolescent International Physical Activity Questionnaire (IPAQ).
time frame: Change from Baseline Level of physical activity at 4,5 month and at 9 month
description: The level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).
It is register and summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.The following values continue to be used for the analysis of IPAQ data: Walking=3.3METs (equivalent metabolic), Moderate PA (physical activity)=4.0METs (Metabolic equivalent) and Vigorous PA=8.0METs (Metabolic equivalent).
Category 1 Low: Those individuals who not meet criteria for Categories 2 or 3. Category 2 Moderate: Total physical activity of at least 600 MET-minutes/week. Category 3 High: a) Total physical activity of at least 3000 MET-minutes/week.
arm group label: Pilates
arm group type: Experimental
description: This group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education.
arm group label: Control
arm group type: No Intervention
description: Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.
intervention type: Other
intervention name: Pilates
description: The intervention program consisted in the realization of exercises of the Pilates Method. The duration of the program was 32 weeks, with a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this time the experimental group developed the intervention program with the Pilates Method.
arm group label: Pilates
criteria: 
gender: All
minimum age: 11 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noelia G Gálvez, PhD.
role: Principal Investigator
affiliation: UCAM
citation: Peterson L, Haladay DE. Pilates-based exercise in the treatment of a patient with persistent low back pain following transforaminal lumbar interbody fusion. Physiother Theory Pract. 2020 Apr;36(4):542-549. doi: 10.1080/09593985.2018.1488905. Epub 2018 Jun 26.
PMID: 29944036
citation: Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
PMID: 29651872
citation: Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.
PMID: 29525763
citation: Kibar S, Yardimci FO, Evcik D, Ay S, Alhan A, Manco M, Ergin ES. Can a pilates exercise program be effective on balance, flexibility and muscle endurance? A randomized controlled trial. J Sports Med Phys Fitness. 2016 Oct;56(10):1139-1146. Epub 2015 Oct 16.
PMID: 26473443
citation: Vaquero-Cristobal R, Lopez-Minarro PA, Alacid Carceles F, Esparza-Ros F. [THE EFFECTS OF THE PILATES METHOD ON HAMSTRING EXTENSIBILITY, PELVIC TILT AND TRUNK FLEXION]. Nutr Hosp. 2015 Nov 1;32(5):1967-86. doi: 10.3305/nh.2015.32.5.9678. Spanish.
PMID: 26545650
citation: Miranda IF, Souza C, Schneider AT, Chagas LC, Loss JF. Comparison of low back mobility and stability exercises from Pilates in non-specific low back pain: A study protocol of a randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:360-368. doi: 10.1016/j.ctcp.2017.12.005. Epub 2017 Dec 8.
PMID: 29248397
citation: Gonzalez-Galvez N, Marcos-Pardo PJ, Carrasco-Poyatos M. Functional improvements after a pilates program in adolescents with a history of back pain: A randomised controlled trial. Complement Ther Clin Pract. 2019 May;35:1-7. doi: 10.1016/j.ctcp.2019.01.006. Epub 2019 Jan 10.
PMID: 31003644
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Noelia González-Gálvez
investigator title: PhD. Noelia González Gálvez
sharing ipd: No