ScoliosisNCT01384955
HRQoL and Function of Adults Treated in Adolescence for Scoliosis With Physical Exercises
An observational study of Scoliosis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 22 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- How many people
- 143 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- clinical diagnosis of scoliosis in adolescence
- participation in exercise program in the Centre of Compensatory Gymnastics in Bielsko-Biala in adolescence
- medical records available
Who cannot join
- contraindications for pulmonary and / or exercise tests
- psychiatric disorders
- recent trauma
- recent traumatic (emotional) event
- contraindications for x-ray exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC 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.
Read the 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.
- Conditions
- Scoliosis
- Keywords
- scoliosis, physical therapy, long term outcome, pulmonary function, physical fitness, health related quality of life, psychopathology
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life
generic and condition-specific questionnaires
Measured: one time point
Secondary outcomes (3)
pulmonary function
spirometry, total lung capacity
Measured: one time point
physical fitness
cycloergometric submaximal physical working capacity test
Measured: one time point
curve progression
x-ray, Cobb angle, trunk rotation, scoliometer
Measured: two time points: data from medical records (past) and present meausserements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Plaszewski, Józef Piłsudski University of Physical Education
- Investigators
- Maciej Plaszewski, PhD, Study director, Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384955
- Sponsor's protocol ID
- DS.136
- Status last verified
- Mar 2015
- First submitted
- 27 Jun 2011
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25436225Plaszewski 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.
PubMed 24574935
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ASSESSMENT OF QUALITY OF LIFE AND FUNCTION OF ADULTS TREATED IN ADOLESCENCE FOR IDIOPATHIC SCOLIOSIS WITH PHYSICAL EXERCISES
- ClinicalTrials.gov ID
- NCT01384955
- Acronym / sponsor ID
- DS.136
- Conditions
- Scoliosis
- Keywords
- scoliosis, physical therapy, long term outcome, pulmonary function, physical fitness, health related quality of life, psychopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- clinical diagnosis of scoliosis in adolescence
- participation in exercise program in the Centre of Compensatory Gymnastics in Bielsko-Biala in adolescence
- medical records available
Key exclusion criteria (5 listed)
- contraindications for pulmonary and / or exercise tests
- psychiatric disorders
- recent trauma
- recent traumatic (emotional) event
- contraindications for x-ray exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
health related quality of life
Time frame: one time point
generic and condition-specific questionnaires
3 secondary outcomes
pulmonary function
Time frame: one time point
physical fitness
Time frame: one time point
curve progression
Time frame: two time points: data from medical records (past) and present meausserements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Derived from this study: PubMed 25436225Plaszewski 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.
- Derived from this study: PubMed 24574935Plaszewski 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.
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Plaszewski, PhD study director
Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health related quality of life (time frame: one time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.