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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise program
Sponsored by
Irmandade da Santa Casa de Misericordia de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Scoliosis, Muscle Strength, Respiratory function tests, Exercise therapy

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmandade da Santa Casa de Misericórdia de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum respiratory pressure measurements by means of a manometer: maximum inspiratory pressure (Pimax) and maximum expiratory pressure (Pemax)

Secondary Outcome Measures

Full Information

First Posted
April 22, 2009
Last Updated
February 25, 2016
Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00886652
Brief Title
An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis
Official Title
Results of an Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Scoliosis, Muscle Strength, Respiratory function tests, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise program
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Lúcia S Alves, PhD
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osmar Avanzi, PhD
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01221-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12186831
Citation
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.
Results Reference
background
PubMed Identifier
15176684
Citation
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.
Results Reference
background
PubMed Identifier
6721285
Citation
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.
Results Reference
background
PubMed Identifier
7434284
Citation
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.
Results Reference
background
PubMed Identifier
16899851
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. doi: 10.1378/chest.130.2.500.
Results Reference
background
PubMed Identifier
10487366
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. doi: 10.1097/00005768-199909000-00005.
Results Reference
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An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis

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