NCT00886652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
Last Updated

February 26, 2016

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

April 22, 2009

Last Update Submit

February 25, 2016

Conditions

Keywords

ScoliosisMuscle StrengthRespiratory function testsExercise therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Exercise

EXPERIMENTAL

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

2

NO INTERVENTION

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.

Interventions

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).

Exercise

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-010, Brazil

Location

Related 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. doi: 10.1164/rccm.166.4.518. No abstract available.

    PMID: 12186831BACKGROUND
  • 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.

    PMID: 15176684BACKGROUND
  • 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.

    PMID: 6721285BACKGROUND
  • 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.

    PMID: 7434284BACKGROUND
  • 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.

    PMID: 16899851BACKGROUND
  • 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.

    PMID: 10487366BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Vera Lúcia S Alves, PhD

    Irmandade da Santa Casa de Misericórdia de São Paulo

    PRINCIPAL INVESTIGATOR
  • Osmar Avanzi, PhD

    Irmandade da Santa Casa de Misericórdia de São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Titular

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 26, 2016

Record last verified: 2009-04

Locations