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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413788
• Other study ID #: Fcmscsp
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2019
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Scoliosis
• Scoliosis

Intervention

Other:
• aerobic exercise
aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)
• combined 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

Device:
• treadmill

Locations

Country	Name	City	State
Brazil	Santa Casa of Sao Paulo Medical School	Sao Paulo

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interleukin 1	Inflammatory Markers	change from baseline in interleukin 1 at 3 months
Primary	interleukin 6	Inflammatory Markers	change from baseline in interleukin 6 at 3 months
Primary	interleukin 8	Inflammatory Markers	change from baseline in interleukin 8 at 3 months
Secondary	distance in six-minute walk test	analysis of distance	change from baseline in distance at 3 months
Secondary	oxygen saturation in six-minute walk test	analysis of oxygen saturation at end of test	change from baseline in oxygen saturation at 3 months
Secondary	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
Secondary	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
Secondary	heart rate in six-minute walk test	analysis of heart rate at end of test	change from baseline in heart rate at 3 months
Secondary	respiratory frequency in six-minute walk test	analysis of respiratory frequency at end of test	change from baseline in respiratory frequency at 3 months
Secondary	Borg scale in six-minute walk test	analysis of Borg scale at end of test	change from baseline in Borg scale at 3 months
Secondary	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
Secondary	maximal inspiratory pressure (MIP)	analysis of maximal inspiratory pressure variation (cmH2O)	change from baseline at 3 months
Secondary	maximal expiratory pressure (MEP)	analysis of maximal expiratory pressure variation (cmH2O)	change from baseline at 3 months
Secondary	peak expiratory flow	peak expiratory flow variation analysis in liters / minute (l/min)	change from baseline at 3 months
Secondary	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
Secondary	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
Secondary	FORCED EXPIRATORY FRACTION (FEF25-75%)	analyzed in milliliters (ml) of lung volume variation from baseline at 3 months	change from baseline at 3 months
Secondary	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