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

March 31, 2015 updated by: Maciej Plaszewski, Józef Piłsudski University of Physical Education

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bielsko-Biala, Poland, 43-300
        • Faculty of Physiotherapy, WSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health related quality of life
Time Frame: one time point
generic and condition-specific questionnaires
one time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary function
Time Frame: one time point
spirometry, total lung capacity
one time point
physical fitness
Time Frame: one time point
cycloergometric submaximal physical working capacity test
one time point
curve progression
Time Frame: two time points: data from medical records (past) and present meausserements
x-ray, Cobb angle, trunk rotation, scoliometer
two time points: data from medical records (past) and present meausserements

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychopathology
Time Frame: one time point
questionnaires / inventories of mental heath (e.g. depression, anxiety)
one time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Józef Piłsudski University of Physical Education

Investigators

  • Study Director: Maciej Plaszewski, PhD, Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (ESTIMATE)

June 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS.136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scoliosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe