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CompletedNCT02413788Updated Sep 6, 2023

Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis

An interventional study of aerobic exercise and combined exercise in Scoliosis and Adolescent Scoliosis, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
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Study summary

Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management.

The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.

Read the detailed description

Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but this deformity potentially involves various musculoskeletal structures permanently, which justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity in exercise performance observed in this population, which must be stimulated to perform standardized physical activity.

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Conditions studied

  • Scoliosis
  • Adolescent Scoliosis

Keywords

  • adolescent idiopathic scoliosis
  • inflammatory markers
  • exercise
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In context

Scoliosis

603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.

This study's enrollment of 40 is close to the median of 44 across 350 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • thoracic curvature ≥ 45 degrees
  • indication for surgical treatment of spinal deformity
  • absence of pulmonary, cardiac, articular or neurological disorder, atopic dermatitis and previous or current allergy
  • agree part in the research with a assent statement and the person responsible with the consent form and informed

Exclusion criteria

Exclusion Criteria:

  • acknowledged chronic liver or kidney inflammatory disease
  • use of corticosteroids, acetylsalicylic acid or other nonhormonal anti-inflammatory clinical or laboratorial evidence of infection
  • severe obesity
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    combined group (treadmill and resisted)

    \- 10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) and resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs (36 sessions)

    Other: combined exercise · Device: treadmill

  • Active comparator
    aerobic group (treadmill)

    10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions

    Other: aerobic exercise · Device: treadmill

Interventions

  • Otheraerobic exercise

    aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)

  • Othercombined exercise

    aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs

  • Devicetreadmill
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What researchers measure

Primary outcomes

  1. interleukin 1

    Inflammatory Markers

    Time frame: change from baseline in interleukin 1 at 3 months

  2. interleukin 6

    Inflammatory Markers

    Time frame: change from baseline in interleukin 6 at 3 months

  3. interleukin 8

    Inflammatory Markers

    Time frame: change from baseline in interleukin 8 at 3 months

Secondary outcomes

  1. distance in six-minute walk test

    analysis of distance

    Time frame: change from baseline in distance at 3 months

  2. oxygen saturation in six-minute walk test

    analysis of oxygen saturation at end of test

    Time frame: change from baseline in oxygen saturation at 3 months

  3. systolic blood pressure in six-minute walk test

    analysis of systolic blood pressure at end of test

    Time frame: change from baseline in systolic blood pressure at 3 months

  4. diastolic blood pressure in six-minute walk test

    analysis of diastolic blood pressure at end of test

    Time frame: change from baseline in diastolic blood pressure at 3 months

  5. heart rate in six-minute walk test

    analysis of heart rate at end of test

    Time frame: change from baseline in heart rate at 3 months

  6. respiratory frequency in six-minute walk test

    analysis of respiratory frequency at end of test

    Time frame: change from baseline in respiratory frequency at 3 months

  7. Borg scale in six-minute walk test

    analysis of Borg scale at end of test

    Time frame: change from baseline in Borg scale at 3 months

  8. forced vital capacity (FVC)

    analyzed in liters or % of predicted of lung capacity variation from baseline at 3 months

    Time frame: change from baseline at 3 months

  9. maximal inspiratory pressure (MIP)

    analysis of maximal inspiratory pressure variation (cmH2O)

    Time frame: change from baseline at 3 months

  10. maximal expiratory pressure (MEP)

    analysis of maximal expiratory pressure variation (cmH2O)

    Time frame: change from baseline at 3 months

  11. peak expiratory flow

    peak expiratory flow variation analysis in liters / minute (l/min)

    Time frame: change from baseline at 3 months

  12. forced expiratory volume in the first second (FEV1)

    analyzed in liters or % of predicted of lung volume variation from baseline at 3 months

    Time frame: change from baseline at 3 months

  13. forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)

    Analysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months

    Time frame: change from baseline at 3 months

  14. FORCED EXPIRATORY FRACTION (FEF25-75%)

    analyzed in milliliters (ml) of lung volume variation from baseline at 3 months

    Time frame: change from baseline at 3 months

  15. FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)

    Analysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months

    Time frame: change from baseline at 3 months

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Study locations

1 site
  • Santa Casa of Sao Paulo Medical School
    São Paulo, 01221-020, Brazil
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References and documents

Publications

  • Xavier VB, Avanzi O, de Carvalho BDMC, Alves VLDS. Combined aerobic and resistance training improves respiratory and exercise outcomes more than aerobic training in adolescents with idiopathic scoliosis: a randomised trial. J Physiother. 2020 Jan;66(1):33-38. doi: 10.1016/j.jphys.2019.11.012. Epub 2019 Dec 16. PubMed 31859153 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02413788
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Profa. Dra. Vera Lúcia dos Santos Alves (PhD in health sciences, Faculdade de Ciências Médicas da Santa Casa de São Paulo) — Principal investigator
First posted
Apr 10, 2015
Start date
Sep 2015
Primary completion
Sep 2015
Completion
Mar 2016
Last update
Sep 6, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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