Adolescent BehaviorSagittalAligNCT03962842
Sagittal Alignment and Extensibility With Pilates in Adolescents
A study testing Pilates method in people with Adolescent Behavior, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Pilates method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be enrolled in Compulsory Secondary Education
- be active in the sessions of Physical Education.
Who cannot join
- presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
- missing more than one session of the programme (91.66% attendance)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sagittal Alignment of the Spine and Hamstring Extensibility With Pilates in Adolescents
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Adolescent Behavior
- Being tested
- Pilates method
- Keywords
- spine, extensibility, children, pilates, exercise, health, physical activity, physical education
- Medical subject headings
- Adolescent Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | This group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education. Receives: Other: Pilates method |
| Control group | No intervention | Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Sagittal spinal curvature
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.
Measured: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month
Change Hamstring extensibility - active straight leg raising test.
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.
Measured: Change from Baseline hamstring extensibility at 4,5 month and at 9 month
Change Hamstring extensibility - passive straight leg raising test.
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.
Measured: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
Secondary outcomes (7)
Change Back pain, physical activity and sedentary behaviour (questionnaire)
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
Measured: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month
Change Quality of life: Kindscreem 27 questionnaire
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
Measured: Change from Baseline Back pain, physical activity and sedentary behaviour at 4,5 month and at 9 month
Change Body mass index
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).
Measured: Change from Baseline Body mass index at 4,5 month and at 9 month
Change Waist-hip ratio
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.
Measured: Change from Baseline Waist-hip ratio at 4,5 month and at 9 month
Change Hamstring extensibility Seat and Reach test The hamstring extensibility is assessed by seat and reach
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.
Measured: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
Change Hamstring extensibility Toe touch test
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.
Measured: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
Change Level of physical activity - Adolescent International Physical Activity Questionnaire (IPAQ)
(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.
Measured: Change from Baseline Level of physical activity at 4,5 month and at 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 May 2019
- Primary completion1 Sep 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
- Investigators
- Noelia G Gálvez, Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962842
- Sponsor's protocol ID
- ProtocolSpinePilates
- Acronym
- SagittalAlig
- Status last verified
- May 2022
- First submitted
- 22 May 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29944036Cruz-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.
PubMed 29651872Miyamoto 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.
PubMed 29525763Kibar 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.
PubMed 26473443Vaquero-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.
PubMed 26545650Miranda 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.
PubMed 29248397Gonzalez-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.
PubMed 31003644
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Alignment of the Spine and Hamstring Extensibility With Pilates in Adolescents
- ClinicalTrials.gov ID
- NCT03962842
- Acronym / sponsor ID
- SagittalAlig / ProtocolSpinePilates
- Conditions
- Adolescent Behavior
- Keywords
- spine, extensibility, children, pilates, exercise, health, physical activity, physical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Other: Pilates methodThis group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education. |
| Control group | No intervention | –Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- be enrolled in Compulsory Secondary Education
- be active in the sessions of Physical Education.
Key exclusion criteria (2 listed)
- presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
- missing more than one session of the programme (91.66% attendance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates methodThe 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. | Other | Pilates group |
Primary outcome
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.
7 secondary outcomes
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
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
Change Body mass index
Time frame: Change from Baseline Body mass index at 4,5 month and at 9 month
Change Waist-hip ratio
Time frame: Change from Baseline Waist-hip ratio at 4,5 month and at 9 month
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
Change Hamstring extensibility Toe touch test
Time frame: Change from Baseline Hamstring extensibility at 4,5 month and at 9 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 29944036Peterson 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.
- Background: PubMed 29651872Cruz-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.
- Background: PubMed 29525763Miyamoto 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.
- Background: PubMed 26473443Kibar 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.
- Background: PubMed 26545650Vaquero-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.
- Background: PubMed 29248397Miranda 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.
- Background: PubMed 31003644Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelia G Gálvez principal investigator
UCAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates method in people with Adolescent Behavior, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Sagittal spinal curvature (time frame: Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962842, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.