HRQoL and Function of Adults Treated in Adolescence for Scoliosis With Physical Exercises

Scoliosis Clinical Trial

Official title:

THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC SCOLIOSIS WITH PHYSICAL EXERCISES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384955
• Other study ID #: DS.136
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: March 31, 2015
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Józef Pilsudski University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 44 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
Poland	Faculty of Physiotherapy, WSA	Bielsko-Biala

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	psychopathology	questionnaires / inventories of mental heath (e.g. depression, anxiety)	one time point	No
Primary	health related quality of life	generic and condition-specific questionnaires	one time point	No
Secondary	pulmonary function	spirometry, total lung capacity	one time point	No
Secondary	physical fitness	cycloergometric submaximal physical working capacity test	one time point	No
Secondary	curve progression	x-ray, Cobb angle, trunk rotation, scoliometer	two time points: data from medical records (past) and present meausserements	No