NCT01384955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

June 27, 2011

Last Update Submit

March 31, 2015

Conditions

Keywords

scoliosisphysical therapylong term outcomepulmonary functionphysical fitnesshealth related quality of lifepsychopathology

Outcome Measures

Primary Outcomes (1)

  • health related quality of life

    generic and condition-specific questionnaires

    one time point

Secondary Outcomes (3)

  • pulmonary function

    one time point

  • physical fitness

    one time point

  • curve progression

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

Other Outcomes (1)

  • psychopathology

    one time point

Study Arms (2)

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

Eligibility Criteria

Age22 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • clinical diagnosis of scoliosis in adolescence
  • participation in exercise program in the Centre of Compensatory Gymnastics in Bielsko-Biala in adolescence
  • medical records available

You may not qualify if:

  • contraindications for pulmonary and / or exercise tests
  • psychiatric disorders
  • recent trauma
  • recent traumatic (emotional) event
  • contraindications for x-ray exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy, WSA

Bielsko-Biala, 43-300, Poland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Maciej Plaszewski, PhD

    Faculty of Physical Education and Sport in Biala Podlaska, University School of Physical Education, Warsaw, Poland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 29, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations