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OpenTrials
Completed

NCT Number: NCT01384955

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

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.

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Key information

Age range

22 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Physiotherapy, WSA

Bielsko-Biala, 43-300, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. health related quality of life

    Time frame: one time point

    generic and condition-specific questionnaires

Secondary outcomes

  1. pulmonary function

    Time frame: one time point

    spirometry, total lung capacity

  2. physical fitness

    Time frame: one time point

    cycloergometric submaximal physical working capacity test

  3. curve progression

    Time frame: two time points: data from medical records (past) and present meausserements

    x-ray, Cobb angle, trunk rotation, scoliometer

Other outcomes

  1. psychopathology

    Time frame: one time point

    questionnaires / inventories of mental heath (e.g. depression, anxiety)

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2011
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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