NCT03831867

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

16 days

First QC Date

January 30, 2019

Last Update Submit

February 4, 2019

Conditions

Keywords

spineextensibilitychildrenhealthpilatesexercisephysical activityphysical education

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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)

    Change from Baseline Sagittal spinal curvature at 4,5 month and at 9 month

  • Change Quality of life: Kindscreem 27 questionnaire

    Change from Baseline Back pain, physical activity and sedentary behaviour at 4,5 month and at 9 month

  • Change Body mass index

    Change from Baseline Body mass index at 4,5 month and at 9 month

  • Change Waist-hip ratio

    Change from Baseline Waist-hip ratio at 4,5 month and at 9 month

  • Change Hamstring extensibility Seat and Reach test

    Change from Baseline Hamstring extensibility at 4,5 month and at 9 month

  • +2 more secondary outcomes

Study Arms (2)

Pilates

EXPERIMENTAL

This group is the experimental group. The intervention program consisted on performance Pilates method exercise program during the sessions of Physical Education.

Other: Pilates

Control

NO INTERVENTION

Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.

Interventions

PilatesOTHER

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.

Pilates

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • be enrolled in Compulsory Secondary Education
  • be active in the sessions of Physical Education.

You may not qualify if:

  • presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
  • missing more than one session of the programme (91.66% attendance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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: 29944036BACKGROUND
  • 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: 29651872BACKGROUND
  • 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: 29525763BACKGROUND
  • 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: 26473443BACKGROUND
  • 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: 26545650BACKGROUND
  • 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: 29248397BACKGROUND
  • 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: 31003644BACKGROUND
  • Gonzalez-Galvez N, Marcos-Pardo PJ, Albaladejo-Saura M, Lopez-Vivancos A, Vaquero-Cristobal R. Effects of a Pilates programme in spinal curvatures and hamstring extensibility in adolescents with thoracic hyperkyphosis: a randomised controlled trial. Postgrad Med J. 2023 Jun 8;99(1171):433-441. doi: 10.1136/postgradmedj-2021-140901.

MeSH Terms

Conditions

Adolescent BehaviorMotor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Noelia G Gálvez, PhD.

    UCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Noelia González Gálvez

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 6, 2019

Study Start

September 15, 2016

Primary Completion

October 1, 2016

Study Completion

June 30, 2017

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share