HRQoL And Function Of Adults Treated In Adolescence For Scoliosis With Physical Exercises

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Józef Piłsudski University of Physical Education.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maciej Plaszewski, Józef Piłsudski University of Physical Education
ClinicalTrials.gov Identifier:
NCT01384955
First received: June 27, 2011
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

We attempt to investigate the influence of physiotherapy and physical activity education applied in adolescence on physical fitness, curve progression, pulmonary function, physical activity and quality of life in adulthood. Quality of life assessment includes mental and social functioning, body image, self - esteem, depression and anxiety surveillance. The follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13 years is available.

The null hypothesis is that scoliosis specific exercise program applied in adolescence does not influence HRQoL and functioning in adulthood.


Condition
Scoliosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC SCOLIOSIS WITH PHYSICAL EXERCISES

Resource links provided by NLM:


Further study details as provided by Józef Piłsudski University of Physical Education:

Primary Outcome Measures:
  • health related quality of life [ Time Frame: one time point ] [ Designated as safety issue: No ]
    generic and condition-specific questionnaires


Secondary Outcome Measures:
  • pulmonary function [ Time Frame: one time point ] [ Designated as safety issue: No ]
    spirometry, total lung capacity

  • physical fitness [ Time Frame: one time point ] [ Designated as safety issue: No ]
    cycloergometric submaximal physical working capacity test

  • curve progression [ Time Frame: two time points: data from medical records (past) and present meausserements ] [ Designated as safety issue: No ]
    x-ray, Cobb angle, trunk rotation, scoliometer


Other Outcome Measures:
  • psychopathology [ Time Frame: one time point ] [ Designated as safety issue: No ]
    questionnaires / inventories of mental heath (e.g. depression, anxiety)


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
exercise
subjects diagnosed and treated in the Centre of Corrective and Compensatory Gymnastics in Bielsko - Biala, Poland, between 1983 and 1994, with scoliosis - specific exercise program
control
age and condition - matched subjects, who were diagnosed at the same time, in the same clinic, and by the same physician, and prescribed the same method of physiotherapy, but did not start the exercise treatment

Detailed Description:

Among conservative treatment approaches of adolescent idiopathic scoliosis (AIS), different physiotherapy methods are recommended and popular in some countries (Spain, Germany, Poland), while in others bracing and observation are standard (North America, Australia, the UK, Scandinavia. Neither of the methods have been shown to be definitely effective. Considerable evidence indicates that bracing can lead to psychological stress, poorer body image and self - esteem and reduce overall quality of life in adulthood. As to physiotherapy and physical exercises, such evidence is limited, especially long term follow up studies are not available.

  Eligibility

Ages Eligible for Study:   22 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Treatment group (retrospection - medical records) - patients diagnosed and / or treated in the Centre of Corrective and Compensatory Gymnastics in Bielsko - Biala, Poland, between 1983 and 1994. Diagnosis: idiopathic scoliosis (IS) - adolescent idiopathic scoliosis (AIS) or early onset idiopathic scoliosis (EOIS) A comparison (control) group: patients with IS, age - and condition - matched, who were diagnosed at the same time, in the same clinic, and by the same physician, and prescribed the same method of physiotherapy, but did not start the exercise treatment.

Criteria

Inclusion Criteria:

  • clinical diagnosis of scoliosis in adolescence
  • participation in exercise program in the Centre of Compensatory Gymnastics in Bielsko-Biala in adolescence
  • medical records available

Exclusion Criteria:

  • contraindications for pulmonary and / or exercise tests
  • psychiatric disorders
  • recent trauma
  • recent traumatic (emotional) event
  • contraindications for x-ray exposure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384955

Contacts
Contact: Maciej Plaszewski, PhD +48 692 427 156 plaszewski@wp.pl

Locations
Poland
Faculty of Physiotherapy, WSA Recruiting
Bielsko-Biala, Poland, 43-300
Contact: Pawel Kowalski, MSc       kovalp@interia.pl   
Sponsors and Collaborators
Józef Piłsudski University of Physical Education
Investigators
Study Director: Maciej Plaszewski, PhD Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland
  More Information

No publications provided by Józef Piłsudski University of Physical Education

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maciej Plaszewski, PhD, Józef Piłsudski University of Physical Education
ClinicalTrials.gov Identifier: NCT01384955     History of Changes
Other Study ID Numbers: DS.136
Study First Received: June 27, 2011
Last Updated: August 23, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Józef Piłsudski University of Physical Education:
scoliosis
physical therapy
long term outcome
pulmonary function
physical fitness
health related quality of life
psychopathology

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

ClinicalTrials.gov processed this record on September 18, 2014