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

Primary Purpose

Scoliosis, Adolescent Scoliosis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

aerobic exercise

combined exercise

treadmill

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring adolescent idiopathic scoliosis, inflammatory markers, exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Santa Casa of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combined group (treadmill and resisted)

aerobic group (treadmill)

Arm Description

- 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)

10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions

Outcomes

Primary Outcome Measures

interleukin 1

Inflammatory Markers

interleukin 6

Inflammatory Markers

interleukin 8

Inflammatory Markers

Secondary Outcome Measures

distance in six-minute walk test

analysis of distance

oxygen saturation in six-minute walk test

analysis of oxygen saturation at end of test

systolic blood pressure in six-minute walk test

analysis of systolic blood pressure at end of test

diastolic blood pressure in six-minute walk test

analysis of diastolic blood pressure at end of test

heart rate in six-minute walk test

analysis of heart rate at end of test

respiratory frequency in six-minute walk test

analysis of respiratory frequency at end of test

Borg scale in six-minute walk test

analysis of Borg scale at end of test

forced vital capacity (FVC)

analyzed in liters or % of predicted of lung capacity variation from baseline at 3 months

maximal inspiratory pressure (MIP)

analysis of maximal inspiratory pressure variation (cmH2O)

maximal expiratory pressure (MEP)

analysis of maximal expiratory pressure variation (cmH2O)

peak expiratory flow

peak expiratory flow variation analysis in liters / minute (l/min)

forced expiratory volume in the first second (FEV1)

analyzed 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)

Analysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months

FORCED EXPIRATORY FRACTION (FEF25-75%)

analyzed in milliliters (ml) of lung volume variation 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

Full Information

NCT ID

NCT02413788

First Posted

March 31, 2015

Last Updated

September 5, 2023

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.

1. Study Identification

Unique Protocol Identification Number

NCT02413788

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scoliosis, Adolescent Scoliosis

Keywords

adolescent idiopathic scoliosis, inflammatory markers, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combined group (treadmill and resisted)

Arm Type

Experimental

Arm Description

Arm Title

aerobic group (treadmill)

Arm Type

Active Comparator

Arm Description

10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions

Intervention Type

Other

Intervention Name(s)

aerobic exercise

Intervention Description

aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)

Intervention Type

Other

Intervention Name(s)

combined exercise

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

treadmill

Primary Outcome Measure Information:

Title

interleukin 1

Description

Inflammatory Markers

Time Frame

change from baseline in interleukin 1 at 3 months

Title

interleukin 6

Description

Inflammatory Markers

Time Frame

change from baseline in interleukin 6 at 3 months

Title

interleukin 8

Description

Inflammatory Markers

Time Frame

change from baseline in interleukin 8 at 3 months

Secondary Outcome Measure Information:

Title

distance in six-minute walk test

Description

analysis of distance

Time Frame

change from baseline in distance at 3 months

Title

oxygen saturation in six-minute walk test

Description

analysis of oxygen saturation at end of test

Time Frame

change from baseline in oxygen saturation at 3 months

Title

systolic blood pressure in six-minute walk test

Description

analysis of systolic blood pressure at end of test

Time Frame

change from baseline in systolic blood pressure at 3 months

Title

diastolic blood pressure in six-minute walk test

Description

analysis of diastolic blood pressure at end of test

Time Frame

change from baseline in diastolic blood pressure at 3 months

Title

heart rate in six-minute walk test

Description

analysis of heart rate at end of test

Time Frame

change from baseline in heart rate at 3 months

Title

respiratory frequency in six-minute walk test

Description

analysis of respiratory frequency at end of test

Time Frame

change from baseline in respiratory frequency at 3 months

Title

Borg scale in six-minute walk test

Description

analysis of Borg scale at end of test

Time Frame

change from baseline in Borg scale at 3 months

Title

forced vital capacity (FVC)

Description

analyzed in liters or % of predicted of lung capacity variation from baseline at 3 months

Time Frame