An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis

NCT ID: NCT00886652

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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Adolescent Idiopathic Scoliosis (AIS) can change the respiratory dynamics and performance of the inspiratory and expiratory muscles, affecting ventilatory capacity. This was a randomized, controlled, open study to test the impact of a physiotherapeutic program of aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic scoliosis. Patients with AIS were randomly assigned to the aerobic exercise-training program group or the no treatment group. There was a significant increase in Pimax and Pemax in the group which received physiotherapy.

Detailed Description

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Study Design: This was a randomized, controlled, open study to test the impact of a physiotherapeutic program of aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic scoliosis (AIS). Objective. To analyze, by means of maximum respiratory pressure measurements, the conditioning of the respiratory muscles after four months of aerobic exercise training. Summary of Background Data. AIS can change the respiratory dynamics and performance of the inspiratory and expiratory muscles, affecting ventilatory capacity.

Methods: Patients with AIS, aged between 10 and 20 years, were randomly assigned to the aerobic exercise-training program group or the no treatment group. They were evaluated for respiratory muscle strength before and after the treatment period, by means of a manometer, and radiographs of the chest and spine. The physical therapy exercise protocol consisted of three weekly sessions, including stretching, aerobic exercises (first mild and then accelerated) and relaxation techniques, for a period of four months.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

The patients of the Exercise group were submitted to a four-month physiotherapy protocol, with three weekly sessions of 60 minutes each, accompanied by a physiotherapist, and consisting of warm-up, aerobic exercise on an electric treadmill, and then winding down and relaxation.

Each patient in this group was therefore submitted to an average of 48 sessions of exercises, always carried out at the same physiotherapy center.

Group Type EXPERIMENTAL

Aerobic exercise program

Intervention Type OTHER

Three weekly sessions, with an interval of one day between each, lasting 60 minutes each, and divided into three separate stages: - A 10-minute warm-up (stretching and low intensity aerobic exercises such as slow, gradual walking); - 40 minutes of aerobic exercise on an electric treadmill, with the work intensity maintained at a 60% to 80% of the maximum heart rate; - 10 minutes of winding down and relaxation (stretching exercises, low energy expenditure aerobics and relaxation techniques).

2

The patients of the control group were not submitted to any type of physical exercises. Like the patients submitted to the protocol, they were evaluated at the beginning, and again after four months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic exercise program

Three weekly sessions, with an interval of one day between each, lasting 60 minutes each, and divided into three separate stages: - A 10-minute warm-up (stretching and low intensity aerobic exercises such as slow, gradual walking); - 40 minutes of aerobic exercise on an electric treadmill, with the work intensity maintained at a 60% to 80% of the maximum heart rate; - 10 minutes of winding down and relaxation (stretching exercises, low energy expenditure aerobics and relaxation techniques).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged between 10 and 20 years
* diagnosed as having adolescent idiopathic scoliosis with a spinal angle of scoliotic deformity of at least 45º, and candidates for surgical correction
* sedentary

Exclusion Criteria

* spinal angle deformities of less than 45º
* previous operation for spinal correction
* comorbidities (lung, heart or neurological diseases) that could interfere with the understanding of the procedures of this study (both diagnostic and interventional)
* regular physical activity
Minimum Eligible Age

10 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irmandade da Santa Casa de Misericordia de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Osmar Avanzi

Professor Titular

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vera Lúcia S Alves, PhD

Role: PRINCIPAL_INVESTIGATOR

Irmandade da Santa Casa de Misericórdia de São Paulo

Osmar Avanzi, PhD

Role: STUDY_CHAIR

Irmandade da Santa Casa de Misericórdia de São Paulo

Locations

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Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

Reference Type BACKGROUND
PMID: 12186831 (View on PubMed)

Windisch W, Hennings E, Sorichter S, Hamm H, Criee CP. Peak or plateau maximal inspiratory mouth pressure: which is best? Eur Respir J. 2004 May;23(5):708-13. doi: 10.1183/09031936.04.00136104.

Reference Type BACKGROUND
PMID: 15176684 (View on PubMed)

Wagener JS, Hibbert ME, Landau LI. Maximal respiratory pressures in children. Am Rev Respir Dis. 1984 May;129(5):873-5. doi: 10.1164/arrd.1984.129.5.873.

Reference Type BACKGROUND
PMID: 6721285 (View on PubMed)

Shneerson JM. Cardiac and respiratory responses to exercise in adolescent idiopathic scoliosis. Thorax. 1980 May;35(5):347-50. doi: 10.1136/thx.35.5.347.

Reference Type BACKGROUND
PMID: 7434284 (View on PubMed)

dos Santos Alves VL, Stirbulov R, Avanzi O. Impact of a physical rehabilitation program on the respiratory function of adolescents with idiopathic scoliosis. Chest. 2006 Aug;130(2):500-5. doi: 10.1378/chest.130.2.500.

Reference Type BACKGROUND
PMID: 16899851 (View on PubMed)

Covey MK, Larson JL, Wirtz S. Reliability of submaximal exercise tests in patients with COPD. Chronic obstructive pulmonary disease. Med Sci Sports Exerc. 1999 Sep;31(9):1257-64. doi: 10.1097/00005768-199909000-00005.

Reference Type BACKGROUND
PMID: 10487366 (View on PubMed)

Other Identifiers

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AIS-301/08

Identifier Type: -

Identifier Source: org_study_id

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