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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02413788
Enrollment
40
Registered
2015-04-10
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Scoliosis, Scoliosis

Keywords

adolescent idiopathic scoliosis, inflammatory markers, exercise

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.

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

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
interleukin 8change from baseline in interleukin 8 at 3 monthsInflammatory Markers
interleukin 1change from baseline in interleukin 1 at 3 monthsInflammatory Markers
interleukin 6change from baseline in interleukin 6 at 3 monthsInflammatory Markers

Secondary

MeasureTime frameDescription
diastolic blood pressure in six-minute walk testchange from baseline in diastolic blood pressure at 3 monthsanalysis of diastolic blood pressure at end of test
heart rate in six-minute walk testchange from baseline in heart rate at 3 monthsanalysis of heart rate at end of test
respiratory frequency in six-minute walk testchange from baseline in respiratory frequency at 3 monthsanalysis of respiratory frequency at end of test
Borg scale in six-minute walk testchange from baseline in Borg scale at 3 monthsanalysis of Borg scale at end of test
forced vital capacity (FVC)change from baseline at 3 monthsanalyzed in liters or % of predicted of lung capacity variation from baseline at 3 months
maximal inspiratory pressure (MIP)change from baseline at 3 monthsanalysis of maximal inspiratory pressure variation (cmH2O)
distance in six-minute walk testchange from baseline in distance at 3 monthsanalysis of distance
peak expiratory flowchange from baseline at 3 monthspeak expiratory flow variation analysis in liters / minute (l/min)
forced expiratory volume in the first second (FEV1)change from baseline at 3 monthsanalyzed in liters or % of predicted of lung volume variation from baseline at 3 months
forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)change from baseline at 3 monthsAnalysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%)change from baseline at 3 monthsanalyzed in milliliters (ml) of lung volume variation from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)change from baseline at 3 monthsAnalysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months
maximal expiratory pressure (MEP)change from baseline at 3 monthsanalysis of maximal expiratory pressure variation (cmH2O)
oxygen saturation in six-minute walk testchange from baseline in oxygen saturation at 3 monthsanalysis of oxygen saturation at end of test
systolic blood pressure in six-minute walk testchange from baseline in systolic blood pressure at 3 monthsanalysis of systolic blood pressure at end of test

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026