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Trial registered on ANZCTR


Registration number
ACTRN12608000511336
Ethics application status
Approved
Date submitted
29/08/2008
Date registered
1/10/2008
Date last updated
1/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maximal respiratory pressure in healthy sedentary 20 to 89 year olds
Scientific title
A study to compare respiratory muscle strength in healthy sedentary 20 to 89 year olds
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory muscle strength in healthy sedentary 20 to 89 year olds 3620 0
Condition category
Condition code
Respiratory 3781 3781 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The voluntaries were submitted to anthropometric evaluation constituted by height and weight measurements (utilizing a stadiometer and a calibrated balance). On the same day, and in just a single session the respiratory muscle strength was evaluated by measurement of maximal inspiratory and expiratory pressure values, utilizing an aneroid manovacuometer. For this, each maneuver it was made at three repetitions (sustaining 1 seconds each repetition) with an interval of one minute between each repetition. The forced inspiratory maneuver was performed from residual volume and the forced expiratory maneuver was performed from total pulmonary capacity. The total time of the session was about 40 minutes.
Intervention code [1] 3331 0
Not applicable
Comparator / control treatment
There are no control groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4673 0
The respiratory muscle strength was measured by an aneroid manovacuometer
Timepoint [1] 4673 0
10 minutes after anthropometric measurements
Secondary outcome [1] 7894 0
To compare the maximal respiratory pressure with the predicted values. After the maximal inspiratory and expiratory pressures measurement were taken for each patient using an aneroid manovacuometer, these values were compared to the predicted values for the Brazilian population according to Neder et al. (1999). The predicted values were calculated for each patient utilizing the following formulas: MIP= -0.80 (age) + 119.7 + 0.48 (weight) and MEP = -0.81 (age) + 165.3.
Timepoint [1] 7894 0
After the subject did three repetitions of each maneuver with an interval of one minute between each repetition.

Eligibility
Key inclusion criteria
Clinically healthy and sedentary individuals. To classify the volunteers as sedentary was applied the Baecke questionnaire for epidemiological studies. The questionnaire included four questions about sport activities, eight about occupational activities and four about habitual leisure habits. According to the sum of scores of the questionnaire, the volunteers were classified as sedentary.
The volunteers should have a body mass index (BMI) between 18.5 to 24.9Kg/m2 and 25.0 to 29.9Kg/m2 in accordance with the World Health Organization classifications for eutrophics and overweight, respectively.
Minimum age
20 Years
Maximum age
89 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers or former smokers; cardiovascular, respiratory, skeletal muscle or neuromuscular pathologies; cognitive deficits or difficulty in understanding maneuvers; sleep dyspnea, cyanosis, thoracic structural alterations, and infections in general in the previous six months.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 760 0
Brazil
State/province [1] 760 0
Sao Paulo, Sao Carlos

Funding & Sponsors
Funding source category [1] 3796 0
University
Name [1] 3796 0
Universidade Camilo Castelo Branco
Address [1] 3796 0
Avenida Hilario da Silva Passos 950. Parque Universitario Descalvado Sao Paulo CEP 13690-970
Country [1] 3796 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Sao Carlos
Address
Rodovia Washington Luis (SP-310), km 235 Sao Carlos - Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3406 0
Other Collaborative groups
Name [1] 3406 0
Laboratorio de Fisioterapia Respiratoria
Address [1] 3406 0
Departamento de Fisioterapia Avenida Hilario da Silva Passos 950. Parque Universitario Descalvado Sao Paulo CEP 13690-970
Country [1] 3406 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5940 0
Comit? de ?tica em Pesquisa - UNICASTELO
Ethics committee address [1] 5940 0
Avenida Hilario da Silva Passos 950. Parque Universitario Descalvado Sao Paulo CEP 13690-970
Ethics committee country [1] 5940 0
Brazil
Date submitted for ethics approval [1] 5940 0
25/06/2004
Approval date [1] 5940 0
28/06/2004
Ethics approval number [1] 5940 0
566-761/04

Summary
Brief summary
Interestingly, studies have found link between the level of physical activity and respiratory muscle strength. Additionally, no study in Brazil proposed to evaluate the respiratory muscle strength in a sample of just healthy volunteers. The purposes of this study were to evaluate the values of the maximal respiratory muscle strength in a sample composed just sedentary healthy subjects and propose predictive equations for maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in Brazilian sedentary healthy individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28328 0
Address 28328 0
Country 28328 0
Phone 28328 0
Fax 28328 0
Email 28328 0
Contact person for public queries
Name 11485 0
Rodrigo Polaquini Simoes
Address 11485 0
Avenida Paulo VI
474 Jardim Cruzeiro do Sul.
Sao Carlos Sao Paulo CEP 13572-140
Country 11485 0
Brazil
Phone 11485 0
055 16 33752540
Fax 11485 0
055 16 33752540
Email 11485 0
rpssimoes@yahoo.com.br
Contact person for scientific queries
Name 2413 0
Rodrigo Polaquini Simoes
Address 2413 0
Avenida Paulo VI
474 Jardim Cruzeiro do Sul.
Sao Carlos Sao Paulo CEP 13572-140
Country 2413 0
Brazil
Phone 2413 0
055 16 33752540
Fax 2413 0
055 16 33752540
Email 2413 0
rpssimoes@yahoo.com.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary