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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scoliosis, Adolescent Scoliosis

Intervention / Treatment
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* Other: aerobic exercise
* Other: combined exercise
* Device: treadmill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined group (treadmill and resisted)<br>- 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<br>* 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<br>Device: treadmill<br> <br> |
| Active Comparator: aerobic group (treadmill)<br>10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions | Other: aerobic exercise<br>* aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)<br>Device: treadmill<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin 1 | Inflammatory Markers | change from baseline in interleukin 1 at 3 months | 
| interleukin 6 | Inflammatory Markers | change from baseline in interleukin 6 at 3 months | 
| interleukin 8 | Inflammatory Markers | change from baseline in interleukin 8 at 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent idiopathic scoliosis, inflammatory markers, exercise