HRQoL And Function Of Adults Treated In Adolescence For Scoliosis With Physical Exercises
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 27, 2011 | ||||
| Last Updated Date | August 23, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
health related quality of life [ Time Frame: one time point ] [ Designated as safety issue: No ] generic and condition-specific questionnaires |
||||
| Original Primary Outcome Measures ICMJE |
pulmonary function [ Time Frame: up to 1 year ] [ Designated as safety issue: No ] total lung capacity, spirometry, flow - volume curve |
||||
| Change History | Complete list of historical versions of study NCT01384955 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE |
psychopathology [ Time Frame: one time point ] [ Designated as safety issue: No ] questionnaires / inventories of mental heath (e.g. depression, anxiety) |
||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HRQoL And Function Of Adults Treated In Adolescence For Scoliosis With Physical Exercises | ||||
| Official Title ICMJE | THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC SCOLIOSIS WITH PHYSICAL EXERCISES | ||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
||||
| Condition ICMJE | Scoliosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 22 Years to 44 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Poland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01384955 | ||||
| Other Study ID Numbers ICMJE | DS.136 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Maciej Plaszewski, Józef Piłsudski University of Physical Education | ||||
| Study Sponsor ICMJE | Józef Piłsudski University of Physical Education | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Józef Piłsudski University of Physical Education | ||||
| Verification Date | August 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||