Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000062325
Ethics application status
Approved
Date submitted
2/01/2008
Date registered
31/01/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mobility of the hip and knee joints in obese children
Scientific title
Range of motion of the hip and knee joints of obese and eutrophic children: a comparative study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 2586 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2697 2697 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Goniometry was performed in hip flexion, extension, abduction, adduction, external rotation and internal rotation, and in knee flexion.
For the intra-assessor reliability, the assessor number 1 performed the measurements of the 50 subjects twice (30 eutrophic and 20 obese), which were compared among them.
For the inter-assessor reliability, the assessor number 2 performed the measurements of the 50 subjects (30 eutrophic and 20 obese) once, which were compared with the measurements of the assessor number 1 to obtain inter-assessor reliability.
The time interval among the 3 measures performed by the assessors was at least 1 week, and at last 1 month.
Intervention code [1] 2319 0
Not applicable
Comparator / control treatment
The hip and knee range of motion of obese/overweight children will be compared with a group of eutrophic children.
Control group
Active

Outcomes
Primary outcome [1] 3595 0
Hip and knee range of motion using a goniometer.
Timepoint [1] 3595 0
5 months
Primary outcome [2] 3596 0
Reliability (intra-assessor reliability and inter-assessor reliability) of the goniometric measurements of hip and knee joints
Timepoint [2] 3596 0
Time interval was at least 1 week, and at last 1 month
Secondary outcome [1] 6020 0
no secondary outcome
Timepoint [1] 6020 0
none

Eligibility
Key inclusion criteria
The Body mass index (BMI) of obese or overweight children had to be above the 85 percentage of the Body mass index (BMI) by age distribution graphic of the National Center for Health Statistics (NCHS), while for the group of eutrophic children, the values had to be under the 85 percentage.
Minimum age
6 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Children with joint hypermobility, metabolical diseases, musculoskeletal diseases, neurological diseases, lower limbs recent injury, and children who practice institutionalized sport or physical exercise in addition to the physical activity proposed by the school in a frequency greater than twice a week and/or greater than 3 hours per week

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 699 0
Brazil
State/province [1] 699 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 2885 0
Government body
Name [1] 2885 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 2885 0
Brazil
Primary sponsor type
Individual
Name
Maira Nomura Nishizaki
Address
Rua Mena, 628 CEP: 07097-001 Guarulhos-SP
Country
Brazil
Secondary sponsor category [1] 2601 0
Individual
Name [1] 2601 0
Silvia Maria Amado Joao
Address [1] 2601 0
Rua Cipotanea, 51 Cidade Universitaria, Sao Paulo 05360-000, SP
Country [1] 2601 0
Brazil
Secondary sponsor category [2] 2604 0
Individual
Name [2] 2604 0
Cynthia Hitomi Yamamoto
Address [2] 2604 0
Avenida Prefeito Fabio Prado, 245, apartamento 3
CEP: 04116-000
S?o Paulo-SP
Country [2] 2604 0
Brazil
Secondary sponsor category [3] 2608 0
Individual
Name [3] 2608 0
Ana Claudia da Cunha Travassos
Address [3] 2608 0
Av Prof Lineu Prestes, 2565, 3 andar
S?o Paulo -SP
Country [3] 2608 0
Brazil
Other collaborator category [1] 108 0
Individual
Name [1] 108 0
Vera Lucia Perino Barbosa
Address [1] 108 0
Rua Major Maragliano 242 Vila Mariana CEP- 04017030
S?o Paulo - SP
Country [1] 108 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4823 0
Comite de Etica do Hospital Universitario da Faculdade de Medicina da Universidade de Sao Paulo
Ethics committee address [1] 4823 0
Ethics committee country [1] 4823 0
Brazil
Date submitted for ethics approval [1] 4823 0
16/09/2005
Approval date [1] 4823 0
18/11/2005
Ethics approval number [1] 4823 0
605/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28214 0
Address 28214 0
Country 28214 0
Phone 28214 0
Fax 28214 0
Email 28214 0
Contact person for public queries
Name 11371 0
Professor Dr. Sílvia Maria Amado João
Address 11371 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional – Universidade de São Paulo
R. Cipotânea 51 Cidade Universitária, São Paulo 05360-000, SP
Country 11371 0
Brazil
Phone 11371 0
+ 55 11 30918424
Fax 11371 0
+ 55 11 30917462
Email 11371 0
[email protected]
Contact person for scientific queries
Name 2299 0
Professor Dr. Sílvia Maria Amado João
Address 2299 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional – Universidade de São Paulo
R. Cipotânea 51 Cidade Universitária, São Paulo 05360-000, SP
Country 2299 0
Brazil
Phone 2299 0
+ 55 11 30918424
Fax 2299 0
+ 55 11 30917462
Email 2299 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.