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

This study has been completed.
Sponsor:
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00886652
First received: April 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Adolescent Idiopathic Scoliosis
Other: Aerobic exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Results of an Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Irmandade da Santa Casa de Misericordia de Sao Paulo:

Primary Outcome Measures:
  • Maximum respiratory pressure measurements by means of a manometer: maximum inspiratory pressure (Pimax) and maximum expiratory pressure (Pemax) [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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).
Other Name: Aerobic exercise program
No Intervention: 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.
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).
Other Name: Aerobic exercise program

Detailed 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.

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886652

Locations
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, SP, Brazil, 01221-010
Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
Principal Investigator: Vera Lúcia S Alves, PhD Irmandade da Santa Casa de Misericórdia de São Paulo
Study Chair: Osmar Avanzi, PhD Irmandade da Santa Casa de Misericórdia de São Paulo
  More Information

Publications:
Responsible Party: Vera Lúcia dos Santos Alves, PT, PhD and Osmar Avanzi, MD, PhD, Departamento de Ortopedia e Traumatologia, "Pavilhão Fernandinho Simonsen"
ClinicalTrials.gov Identifier: NCT00886652     History of Changes
Other Study ID Numbers: AIS-301/08
Study First Received: April 22, 2009
Last Updated: April 22, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Irmandade da Santa Casa de Misericordia de Sao Paulo:
Scoliosis
Muscle Strength
Respiratory function tests
Exercise therapy

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 23, 2014