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Musculoskeletal and Connective Tissue DisordersNCT02255695

Effects of a School-based Exercise Program on Posture, Trunk Range of Motion, and Musculoskeletal Pain

A study testing School-based exercise program in people with Musculoskeletal and Connective Tissue Disorders, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to evaluate the effects of a school-based exercise program on posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was a Randomized controlled trial. Read more about this study

Who is it for?
Ages 5 to 18 yearsHealthy volunteers can take part
What is being tested?
School-based exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteBrazil
Study dates
Dec 2008to Dec 2012
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 5 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Inclusion Criteria: to attend elementary school and deliver the consent term signed by the parents.

-

Exclusion Criteria: presence of disability on musculoskeletal or neurological system, exercise intolerance or attendance less than 50% in the exercise sections

-

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal de São Carlos

    São Carlos, São Paulo, 13.565-905

Other trials in Brazil

About this study

Official title: Effects of a School-based Exercise Program on Posture, Trunk Range of Motion, and Musculoskeletal Pain - A Randomized, Controlled Trial

The objective of this study was to evaluate the effects of a school-based exercise program on posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was a Randomized controlled trial. The hypothesis was that the exercise group would have the postural deviations corrected, would have the trunk range of motion increased and would have the prevalence of pain decreased, while the control group would have not. Three schools from Brazil participated. The students that have been included (n=300) were randomly allocated to experimental (EG) or control group (CG). The intervention for EG consisted in a program based on stretching and strengthening exercises, applied twice a week, for eight weeks, with group sessions of 50 minutes. CG did not perform any intervention. Qualitative and quantitative postural evaluation (PAS/SAPO), musculoskeletal pain (self-report) and trunk mobility were collected.

Being tested
School-based exercise program
Keywords
posture, child, prevention, muscle strength, muscle stretching exercises, exercise therapy, disease management, musculoskeletal pain, adolescent, spinal curvatures
Medical subject headings
Connective Tissue Diseases, Musculoskeletal Pain, Spinal Curvatures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • School-based exercise programOther

    Also called Exercise group, Intervention group, Program based on stretching and strengthening exercises

    The exercise program was applied, twice a week, for 8 weeks, with sessions of 50 minutes, in groups of 10 students. The exercise program was elaborate to restore muscular balance through flexibility, endurance and muscular strength. To promote flexibility stretching exercises for rotator neck muscles, lateral neck flexors, levator scapulae, upper trapezius, erector spinae, major and minor pectoralis, rhomboids, spinal lateral flexors, column rotators, piriformis, hamstrings, quadriceps, hip adductors and abductors were applied. Strengthening exercises were applied for the development of strength, endurance and control of deep flexor muscles of the cervical spine, stabilizers of the glenohumeral joint and scapula, abdominals, spine extensors and hip extensors.

Study groups in NCT02255695
Study groupRoleWhat they receive
Control groupNo interventionControl group
School-based exercise programExperimentalSchool-based exercise program
Receives: Other: School-based exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the qualitative postural assessment from the baseline

    Qualitative postural assessment was performed by a physiotherapist through the photographic records. The photos were recorded with the students in swimsuits and no shoes. The subject was positioned over the gyratory platform to avoid reposition for the photographic record, besides the plumb line, with the feet lined and separated by hip width. The records were performed in the frontal and sagittal planes, in the anterior, posterior and lateral view. According to the positioning of the structures in relation to the plumb line, the presence of postural changes was classified by the physiotherapist. Lateral tilt and forward head, shoulder protrusion, cervical lordosis, thoracic kyphosis, and lumbar lordosis were evaluated.

    Measured: Two time points: baseline and 9 weeks

Secondary outcomes (3)

  1. Changes in the quantitative postural assessment from the baseline

    Postural Assessment Software (PAS/SAPo) was used to quantitatively assess posture. Reflective markers were placed by a trained physiotherapist on the anatomical landmarks of the subject. The subject was positioned over the gyratory platform, and photographic records were performed in the frontal and sagittal planes, in the anterior, posterior and lateral view.

    The analysis followed the guidelines of PAS/SAPo. The photos were aligned and calibrated. The reflective markers were identified and the protocol of measures of the PAS/SAPo was used, providing the following parameters: horizontal alignment of the acromions, horizontal alignment of the ASIS, angle between acromions and ASIS, vertical alignment of the trunk, horizontal alignment of the pelvis, horizontal alignment of the head, vertical alignment of the head.

    Measured: Two time points: baseline and 9 weeks

  2. Changes in trunk range of motion from baseline

    A photogrammetric technique was used to measure the trunk flexion angle. This angle is formed between the line joining the markers attached on anterior superior iliac spine (ASIS) and greater trochanter and the line joining the marker fixed on the spinous process of the C7 vertebra and the one fixed on the ASIS. Two photographs were recorded; one in the upright position and the other in maximum trunk flexion. The trunk mobility was estimated by the difference between the values obtained in the two photographs. This procedure was performed in PAS/SAPo software.

    Measured: Two time points: baseline and 9 weeks

  3. Changes in the prevalence of musculoskeletal pain from baseline

    The presence of pain was evaluated by self-report. The Nordic Questionnaire of Musculoskeletal Symptoms body map was used to provide pain localization and data from musculoskeletal pain during the last 7 days. The pain intensity was also investigated by asking to the children about their pain in a 11-point scale, in which 0 is lack of pain and 10 is the greatest pain that the children had ever experienced.

    Measured: Two time points: baseline and 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02255695
Sponsor's protocol ID
472552/2010-4
Status last verified
Sep 2014
First submitted
24 Jul 2014
Last updated
2 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Cardon G, Balague F. Low back pain prevention's effects in schoolchildren. What is the evidence? Eur Spine J. 2004 Dec;13(8):663-79. doi: 10.1007/s00586-004-0749-6. Epub 2004 Jun 15.

    PubMed 15662541

  • Hakala P, Rimpela A, Salminen JJ, Virtanen SM, Rimpela M. Back, neck, and shoulder pain in Finnish adolescents: national cross sectional surveys. BMJ. 2002 Oct 5;325(7367):743. doi: 10.1136/bmj.325.7367.743.

    PubMed 12364301

  • Limon S, Valinsky LJ, Ben-Shalom Y. Children at risk: risk factors for low back pain in the elementary school environment. Spine (Phila Pa 1976). 2004 Mar 15;29(6):697-702. doi: 10.1097/01.brs.0000116695.09697.22.

    PubMed 15014281

  • van Gent C, Dols JJ, de Rover CM, Hira Sing RA, de Vet HC. The weight of schoolbags and the occurrence of neck, shoulder, and back pain in young adolescents. Spine (Phila Pa 1976). 2003 May 1;28(9):916-21. doi: 10.1097/01.BRS.0000058721.69053.EC.

    PubMed 12942008

  • Coleman J, Straker L, Ciccarelli M. Why do children think they get discomfort related to daily activities? Work. 2009;32(3):267-74. doi: 10.3233/WOR-2009-0825.

    PubMed 19369719

  • Juskeliene V, Magnus P, Bakketeig LS, Dailidiene N, Jurkuvenas V. Prevalence and risk factors for asymmetric posture in preschool children aged 6-7 years. Int J Epidemiol. 1996 Oct;25(5):1053-9. doi: 10.1093/ije/25.5.1053.

    PubMed 8921494

  • Hrysomallis C, Goodman C. A review of resistance exercise and posture realignment. J Strength Cond Res. 2001 Aug;15(3):385-90.

    PubMed 11710670

  • Kjaer P, Leboeuf-Yde C, Sorensen JS, Bendix T. An epidemiologic study of MRI and low back pain in 13-year-old children. Spine (Phila Pa 1976). 2005 Apr 1;30(7):798-806. doi: 10.1097/01.brs.0000157424.72598.ec.

    PubMed 15803084

  • Correa EC, Berzin F. Efficacy of physical therapy on cervical muscle activity and on body posture in school-age mouth breathing children. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1527-35. doi: 10.1016/j.ijporl.2007.05.031. Epub 2007 Jul 30.

    PubMed 17659787

  • Zaina F, Atanasio S, Ferraro C, Fusco C, Negrini A, Romano M, Negrini S. Review of rehabilitation and orthopedic conservative approach to sagittal plane diseases during growth: hyperkyphosis, junctional kyphosis, and Scheuermann disease. Eur J Phys Rehabil Med. 2009 Dec;45(4):595-603.

    PubMed 20032919

  • Ahlqwist A, Hagman M, Kjellby-Wendt G, Beckung E. Physical therapy treatment of back complaints on children and adolescents. Spine (Phila Pa 1976). 2008 Sep 15;33(20):E721-7. doi: 10.1097/BRS.0b013e318182c347.

    PubMed 18794746

  • Fanucchi GL, Stewart A, Jordaan R, Becker P. Exercise reduces the intensity and prevalence of low back pain in 12-13 year old children: a randomised trial. Aust J Physiother. 2009;55(2):97-104. doi: 10.1016/s0004-9514(09)70039-x.

    PubMed 19463080

  • Jones MA, Stratton G, Reilly T, Unnithan VB. Recurrent non-specific low-back pain in adolescents: the role of exercise. Ergonomics. 2007 Oct;50(10):1680-8. doi: 10.1080/00140130701587327.

    PubMed 17917907

  • Whistance RS, Adams LP, van Geems BA, Bridger RS. Postural adaptations to workbench modifications in standing workers. Ergonomics. 1995 Dec;38(12):2485-503. doi: 10.1080/00140139508925282.

    PubMed 8586077

  • Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.

    PubMed 17304690

Questions about this trial

What is this clinical trial studying?

A study testing School-based exercise program in people with Musculoskeletal and Connective Tissue Disorders, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 2 Oct 2014. 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 Brazil. 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?

Changes in the qualitative postural assessment from the baseline (time frame: Two time points: baseline and 9 weeks). 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 NCT02255695, which also lists 17 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 2 Oct 2014.

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