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Clinical Trials/NCT02413788
NCT02413788
Completed
Not Applicable

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

Faculdade de Ciências Médicas da Santa Casa de São Paulo1 site in 1 country40 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Enrollment
40
Locations
1
Primary Endpoint
interleukin 6
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
March 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Profa. Dra. Vera Lúcia dos Santos Alves

PhD in health sciences

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

interleukin 6

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

Inflammatory Markers

interleukin 8

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

Inflammatory Markers

interleukin 1

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

Inflammatory Markers

Secondary Outcomes

  • oxygen saturation in six-minute walk test(change from baseline in oxygen saturation at 3 months)
  • distance in six-minute walk test(change from baseline in distance at 3 months)
  • systolic blood pressure in six-minute walk test(change from baseline in systolic blood pressure at 3 months)
  • heart rate in six-minute walk test(change from baseline in heart rate at 3 months)
  • respiratory frequency in six-minute walk test(change from baseline in respiratory frequency at 3 months)
  • peak expiratory flow(change from baseline at 3 months)
  • forced vital capacity (FVC)(change from baseline at 3 months)
  • FORCED EXPIRATORY FRACTION (FEF25-75%)(change from baseline at 3 months)
  • diastolic blood pressure in six-minute walk test(change from baseline in diastolic blood pressure at 3 months)
  • forced expiratory volume in the first second (FEV1)(change from baseline at 3 months)
  • forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)(change from baseline at 3 months)
  • Borg scale in six-minute walk test(change from baseline in Borg scale at 3 months)
  • maximal inspiratory pressure (MIP)(change from baseline at 3 months)
  • maximal expiratory pressure (MEP)(change from baseline at 3 months)
  • FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)(change from baseline at 3 months)

Study Sites (1)

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