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

NCT02413788 | Completed DMC

• 1 other identifier: Fcmscsp
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescent Scoliosis

Keywords

adolescent idiopathic scoliosis; inflammatory markers; exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• distance in six-minute walk test

  change from baseline in distance at 3 months

• oxygen saturation in six-minute walk test

  change from baseline in oxygen saturation at 3 months

• systolic blood pressure in six-minute walk test

  change from baseline in systolic blood pressure at 3 months

• diastolic blood pressure in six-minute walk test

  change from baseline in diastolic blood pressure at 3 months

• heart rate in six-minute walk test

  change from baseline in heart rate at 3 months

Study Arms (2)

combined group (treadmill and resisted)

EXPERIMENTAL

\- 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; Device: treadmill

aerobic group (treadmill)

ACTIVE COMPARATOR

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

Other: aerobic exercise; Device: treadmill

Interventions

aerobic exercise OTHER

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

aerobic group (treadmill)

combined exercise OTHER

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

combined group (treadmill and resisted)

treadmill DEVICE

aerobic group (treadmill); combined group (treadmill and resisted)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31859153 DERIVED

MeSH Terms

Conditions

Scoliosis; Motor Activity

Interventions

Exercise; Exercise Test

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in health sciences

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 10, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 6, 2023

Record last verified: 2019-11

Locations

BR (1)