Clinical trial NCT01384955: HRQoL and Function of Adults Treated in Adolescence for Scoliosis With Physical Exercises
Official title: THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC SCOLIOSIS WITH PHYSICAL EXERCISES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: scoliosis
physical therapy
long term outcome
pulmonary function
physical fitness
health related quality of life
psychopathology
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 143
Sex: ALL
Minimum age (years): 22
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: health related quality of life
timeFrame: one time point
Secondary outcomes:
measure: pulmonary function
timeFrame: one time point
measure: physical fitness
timeFrame: one time point
measure: curve progression
timeFrame: two time points: data from medical records (past) and present meausserements
Other outcomes:
measure: psychopathology
timeFrame: one time point
Locations:
city: Bielsko-Biala
country: Poland
facility: Faculty of Physiotherapy, WSA
Study officials:
affiliation: Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland
name: Maciej Plaszewski, PhD
role: STUDY_DIRECTOR
References:
citation: Plaszewski M, Cieslinski I, Kowalski P, Truszczynska A, Nowobilski R. Does scoliosis-specific exercise treatment in adolescence alter adult quality of life? ScientificWorldJournal. 2014;2014:539671. doi: 10.1155/2014/539671. Epub 2014 Nov 10.
citation: Plaszewski M, Cieslinski I, Nowobilski R, Kotwicki T, Terech J, Furgal M. Mental health of adults treated in adolescence with scoliosis-specific exercise program or observed for idiopathic scoliosis. ScientificWorldJournal. 2014 Jan 20;2014:932827. doi: 10.1155/2014/932827. eCollection 2014.