Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000045910
Ethics application status
Approved
Date submitted
7/01/2011
Date registered
13/01/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac autonomic modulation after physical exercise in non-obese versus morbidly obese pre-adolescents
Scientific title
Heart rate variability analysis of pre-adolescents with morbid obesity after aerobic physical exercise
Secondary ID [1] 253308 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The cardiac autonomic control after aerobic exercise in pre-adolescents morbidly obese 258840 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258980 258980 0 0
Physiotherapy
Diet and Nutrition 259066 259066 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Incremental effort test conducted on treadmill to determine the intensity considered level 13 of Borg's perceived effort scale by each volunteer. This test was undertaken 48h before the continuous aerobic exercise.
2. Performing of 30min of continuous aerobic exercise running on treadmill at level 13 of Borg's scale.
3. Recording of heart beats after exercise for heart rate variability analysis
Intervention code [1] 257759 0
Early detection / Screening
Intervention code [2] 257760 0
Rehabilitation
Comparator / control treatment
The control group was accompanied by us in another study conducted during one year, so we already knew these volunteers. In this present study the data also were collected during one year. The volunteers of this group were non-obese and sedentary pre-adolescents.
Control group
Historical

Outcomes
Primary outcome [1] 259834 0
The heart rate variability (HRV) was assessed by Polar S810 and analyzed by the software Polar Precision Performance. The data were analyzed by time and frequency domain. The frequency domain was obtained with the use Fast Fourier Transformed (FFT).
All data were submitted to a filter (very strong) to avoid the artefacts and were obtained in stable conditions (rest and continuous dynamic exercise).
Timepoint [1] 259834 0
The heart beats were recorded for HRV analysis during the 10 to 20min following 30 minutes of aerobic exercise.
Secondary outcome [1] 268688 0
nil
Timepoint [1] 268688 0
nil

Eligibility
Key inclusion criteria
Ages between 9 and 11.
All sedentaries.
Non-obeses with body mass index (BMI) with percentil of National Center for Chronic Disease Prevention and Health Promotion. between 5 and 85.
Morbid obeses with body mass index (BMI) with percentil of National Center for Chronic Disease Prevention and Health Promotion, over 97.
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any medications.
Obesity caused by physical problems or by any detectable disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects were selected after the researcher conduct a lecture at their schools about the survey and explaining its importance. Then they were selected respecting the criteria for inclusion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3096 0
Brazil
State/province [1] 3096 0
SP

Funding & Sponsors
Funding source category [1] 258225 0
University
Name [1] 258225 0
Pontificia Universidade Catolica de Campinas
Country [1] 258225 0
Brazil
Primary sponsor type
University
Name
Pontificia Universidade Catolica de Campinas
Address
Av John Boyd Dunlop. s/n Campus II
Jdim Ipaussurama - Campinas SP
CEP: 13060-904
Country
Brazil
Secondary sponsor category [1] 257462 0
Individual
Name [1] 257462 0
Mario Augusto Paschoal
Address [1] 257462 0
Rua Ferreira Penteado, 1242 ap72
cambui - Campinas SP
CEP:13010-041
Country [1] 257462 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260256 0
Comite de Etica em pesquisa com seres humanos da PUC Campinas
Ethics committee address [1] 260256 0
Ethics committee country [1] 260256 0
Brazil
Date submitted for ethics approval [1] 260256 0
Approval date [1] 260256 0
Ethics approval number [1] 260256 0

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

Contacts
Principal investigator
Name 32024 0
Address 32024 0
Country 32024 0
Phone 32024 0
Fax 32024 0
Email 32024 0
Contact person for public queries
Name 15271 0
MARIO AUGUSTO PASCHOAL
Address 15271 0
Rua Ferreira Penteado, 1242 ap72
cambui - Campinas SP
CEP:13010-041
Country 15271 0
Brazil
Phone 15271 0
551935796820
Fax 15271 0
551935796820
Email 15271 0
fisioni@puc-campinas.edu.br
Contact person for scientific queries
Name 6199 0
MARIO AUGUSTO PASCHOAL
Address 6199 0
Rua Ferreira Penteado, 1242 ap72
cambui - Campinas SP
CEP:13010-041
Country 6199 0
Brazil
Phone 6199 0
551935796820
Fax 6199 0
551935796820
Email 6199 0
fisioni@puc-campinas.edu.br

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.