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Completed

NCT Number: NCT02413788

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

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.

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Key information

Conditions

Scoliosis Adolescent Scoliosis Behavior Bone Diseases Motor Activity Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Aerobic Exercise

Other

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

Combined exercise

Other

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

Treadmill

Device

Primary outcomes

  1. interleukin 1

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

    Inflammatory Markers

  2. interleukin 6

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

    Inflammatory Markers

  3. interleukin 8

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

    Inflammatory Markers

Secondary outcomes

  1. distance in six-minute walk test

    Time frame: change from baseline in distance at 3 months

    analysis of distance

  2. oxygen saturation in six-minute walk test

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

    analysis of oxygen saturation at end of test

  3. systolic blood pressure in six-minute walk test

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

    analysis of systolic blood pressure at end of test

  4. diastolic blood pressure in six-minute walk test

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

    analysis of diastolic blood pressure at end of test

  5. heart rate in six-minute walk test

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

    analysis of heart rate at end of test

  6. respiratory frequency in six-minute walk test

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

    analysis of respiratory frequency at end of test

  7. Borg scale in six-minute walk test

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

    analysis of Borg scale at end of test

  8. forced vital capacity (FVC)

    Time frame: change from baseline at 3 months

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

  9. maximal inspiratory pressure (MIP)

    Time frame: change from baseline at 3 months

    analysis of maximal inspiratory pressure variation (cmH2O)

  10. maximal expiratory pressure (MEP)

    Time frame: change from baseline at 3 months

    analysis of maximal expiratory pressure variation (cmH2O)

  11. peak expiratory flow

    Time frame: change from baseline at 3 months

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

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

    Time frame: change from baseline at 3 months

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

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

    Time frame: change from baseline at 3 months

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

  14. FORCED EXPIRATORY FRACTION (FEF25-75%)

    Time frame: change from baseline at 3 months

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

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

    Time frame: change from baseline at 3 months

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

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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