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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Results of an Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886652
• Other study ID #: AIS-301/08
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: February 25, 2016
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Shneerson JM. Cardiac and respiratory responses to exercise in adolescent idiopathic scoliosis. Thorax. 1980 May;35(5):347-50. — View Citation

Wagener JS, Hibbert ME, Landau LI. Maximal respiratory pressures in children. Am Rev Respir Dis. 1984 May;129(5):873-5. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum respiratory pressure measurements by means of a manometer: maximum inspiratory pressure (Pimax) and maximum expiratory pressure (Pemax)		Before the start of the proposed exercises, and one day after the last session of the exercise protocol, all the patients were evaluated using a manovacuometer.	No