Clinical trial NCT02413788: Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
Official title: Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Adolescent Scoliosis
Keywords: adolescent idiopathic scoliosis
inflammatory markers
exercise
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: interleukin 1
timeFrame: change from baseline in interleukin 1 at 3 months
measure: interleukin 6
timeFrame: change from baseline in interleukin 6 at 3 months
measure: interleukin 8
timeFrame: change from baseline in interleukin 8 at 3 months
Secondary outcomes:
measure: distance in six-minute walk test
timeFrame: change from baseline in distance at 3 months
measure: oxygen saturation in six-minute walk test
timeFrame: change from baseline in oxygen saturation at 3 months
measure: systolic blood pressure in six-minute walk test
timeFrame: change from baseline in systolic blood pressure at 3 months
measure: diastolic blood pressure in six-minute walk test
timeFrame: change from baseline in diastolic blood pressure at 3 months
measure: heart rate in six-minute walk test
timeFrame: change from baseline in heart rate at 3 months
measure: respiratory frequency in six-minute walk test
timeFrame: change from baseline in respiratory frequency at 3 months
measure: Borg scale in six-minute walk test
timeFrame: change from baseline in Borg scale at 3 months
measure: forced vital capacity (FVC)
timeFrame: change from baseline at 3 months
measure: maximal inspiratory pressure (MIP)
timeFrame: change from baseline at 3 months
measure: maximal expiratory pressure (MEP)
timeFrame: change from baseline at 3 months
measure: peak expiratory flow
timeFrame: change from baseline at 3 months
measure: forced expiratory volume in the first second (FEV1)
timeFrame: change from baseline at 3 months
measure: forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)
timeFrame: change from baseline at 3 months
measure: FORCED EXPIRATORY FRACTION (FEF25-75%)
timeFrame: change from baseline at 3 months
measure: FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)
timeFrame: change from baseline at 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Santa Casa of Sao Paulo Medical School
Study officials:
References:
citation: 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.