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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescent Scoliosis
• Intervention / Treatment: Other: combined exercise; Device: treadmill; Other: aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01221-020
    • Santa Casa of Sao Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimated): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: exercise; inflammatory markers; adolescent idiopathic scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Fcmscsp