Sagittal Alignment and Extensibility With Pilates in Adolescents (SagittalAlig)
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| ClinicalTrials.gov Identifier: NCT03962842 |
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Recruitment Status : Unknown
Verified May 2019 by Noelia González-Gálvez, Universidad Católica San Antonio de Murcia.
Recruitment status was: Recruiting
First Posted : May 24, 2019
Last Update Posted : May 28, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adolescent Behavior | Other: Pilates method | Not Applicable |
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 pretest, 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 163 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Sagittal Alignment of the Spine and Hamstring Extensibility With Pilates in Adolescents |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | September 1, 2019 |
| Estimated Study Completion Date : | June 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pilates group
This group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education.
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Other: Pilates method
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. |
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No Intervention: Control group
Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.
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- Change Sagittal spinal curvature [ Time Frame: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month ]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.
- Change Hamstring extensibility - active straight leg raising test. [ Time Frame: Change from Baseline hamstring extensibility at 4,5 month and at 9 month ]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.
- Change Hamstring extensibility - passive straight leg raising test. [ Time Frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month ]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.
- 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 ]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
- 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 ]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
- Change Body mass index [ Time Frame: Change from Baseline Body mass index at 4,5 month and at 9 month ]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).
- Change Waist-hip ratio [ Time Frame: Change from Baseline Waist-hip ratio at 4,5 month and at 9 month ]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.
- Change Hamstring extensibility Seat and Reach test The hamstring extensibility is assessed by seat and reach [ Time Frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month ]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.
- Change Hamstring extensibility Toe touch test [ Time Frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month ]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.
- 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 ](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.
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| Ages Eligible for Study: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- be enrolled in Compulsory Secondary Education
- be active in the sessions of Physical Education.
Exclusion Criteria:
- presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
- missing more than one session of the programme (91.66% attendance)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962842
| Contact: Noelia G Gálvez | 627146613 | ngonzalez@ucam.edu |
| Spain | |
| Noelia González Gálvez | Recruiting |
| Murcia, Spain, 30010 | |
| Contact: Noelia G Gálvez 627146613 | |
| Contact ngonzalez@ucam.edu | |
| Principal Investigator: | Noelia G Gálvez | UCAM |
| Responsible Party: | Noelia González-Gálvez, Principal Investigator, Universidad Católica San Antonio de Murcia |
| ClinicalTrials.gov Identifier: | NCT03962842 |
| Other Study ID Numbers: |
ProtocolSpinePilates |
| First Posted: | May 24, 2019 Key Record Dates |
| Last Update Posted: | May 28, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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spine extensibility children pilates |
exercise health physical activity physical education |