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Trial registered on ANZCTR


Registration number
ACTRN12608000136303
Ethics application status
Approved
Date submitted
13/03/2008
Date registered
17/03/2008
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of respiratory muscle strength of the institutionalised elderly women
Scientific title
Evaluation of respiratory muscle strength in institutionalized elderly women 60 to 89 years old
Secondary ID [1] 299882 0
Nil known'.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health elderly women (evaluation of respiratory muscle strength) 2925 0
Condition category
Condition code
Respiratory 3061 3061 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
Anthropometric, respiratory muscle evaluation to compare the respiratory muscle strength of institutionalized women with the predicted values for the Brazilian population.
First, women will be 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 will be evaluated by measurement of maximal inspiratory and expiratory pressure values, utilizing an aneroid manovacuometer. For this, each maneuver it will be made at three repetitions 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.
Intervention code [1] 2654 0
Not applicable
Comparator / control treatment
There are no comparator/control treatments as this is an Observational study
Control group
Historical

Outcomes
Primary outcome [1] 3944 0
To evaluate the respiratory muscle strength of institutionalized women and to compare with the predicted values for the Brazilian population. The respiratory muscle strength will be inferred through measurement of the sub and supra atmospheric pressure generated by inspiratory and expiratory muscles respectively, for this will be utilized an aneroid manovacuometer. The inspiratory and expiratory pressures evaluated through the mouth, reflect the pressure that is being generated in the alveolus by the action of respiratory muscles. This technique has been widely utilized to be characterized noninvasive method and its objectives are to identify possible weakness, fatigue and respiratory muscle failure, as well as to quantify the effects of respiratory training.
Timepoint [1] 3944 0
20 minutes after anthropometric evaluation
Secondary outcome [1] 6625 0
To correlate the maximal respiratory pressure values with age, weight, height and body mass index
Timepoint [1] 6625 0
Conducted during the analysis of data about 60 days after anthropometric and respiratory evaluation.

Eligibility
Key inclusion criteria
Institutionalized elderly women aged 60 to 89 years with a body mass index (BMI) classification of eutrophic (BMI from 18.5 to 24.9 kg/m2) or overweight (BMI from 25 to 29.9 kg/m2) in accordance with the World Health Organization criteria and who were not involved in regular physical activity.
Minimum age
60 Years
Maximum age
89 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior history of cardiovascular or respiratory diseases, smokers, alterations in the thoracic or abdominal regions such as retractions cutaneous or accentuated structural deviations in the spinal column.

Study design
Purpose
Screening
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] 819 0
Brazil
State/province [1] 819 0
Sao Paulo, Sao Carlos

Funding & Sponsors
Funding source category [1] 3178 0
University
Name [1] 3178 0
Universidade Camilo Castelo Branco
Address [1] 3178 0
Avenida Hilario da Silva Passos
950. Parque Universitario
Descalvado Sao Paulo CEP 13690-970
Country [1] 3178 0
Brazil
Primary sponsor type
Individual
Name
Marisa Mazzonetto de Oliveira
Address
Dr Alderico Vieira Perdigao
125 CEP 13572-000
Jardim Cruzeiro do Sul
Sao Carlos Sao Paulo
Country
Brazil
Secondary sponsor category [1] 2846 0
Other Collaborative groups
Name [1] 2846 0
Laboratorio de Fisioterapia Respiratoria
Address [1] 2846 0
Departamento de Fisioterapia
Avenida Hilario da Silva Passos
950. Parque Universitario
Descalvado Sao Paulo CEP 13690-970
Country [1] 2846 0
Brazil
Secondary sponsor category [2] 2850 0
None
Name [2] 2850 0
None
Address [2] 2850 0
None
Country [2] 2850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304791 0
Comitê de Ética da Universidade Camilo Castello Branco
Ethics committee address [1] 304791 0
Av. Hilário de Silva Passos, 950 - Parque Universitário, Descalvado - SP, 13690-000
Ethics committee country [1] 304791 0
Brazil
Date submitted for ethics approval [1] 304791 0
03/02/2004
Approval date [1] 304791 0
13/04/2004
Ethics approval number [1] 304791 0
Nil known'.

Summary
Brief summary
Evaluation of respiratory muscle strength by maximal respiratory pressure (maximal inspiratory pressure and maximal expiratory pressure) is of great clinical importance because it is a quick, simple, non-invasive and low cost procedure that has great diagnostic and prognostic potential for innumerous pulmonary disorders, furthermore is associated to general state of the individual’s health. Moreover, studies report that the respiratory muscle strength is linked to the level of physical effort during daily living activities. Based on this fact, we hypothesized that the maximal respiratory pressure of the institutionalized elderly is lower when compared to the normal values predicted to Brazilian population.
Thus, the objectives of this study were to evaluate the respiratory muscle strength through measurement of maximum inspiratory and expiratory pressures, in institutionalized women from 60 to 89 years of age and compare this data to the predicted values for the Brazilian population.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 28435 0
Dr Rodrigo Polaquini Simões
Address 28435 0
Principal investigator: Rodrigo Polaquini Simões. Avenida Comendador Alfredo Maffei, 1390, 22A.
Country 28435 0
Brazil
Phone 28435 0
+55 16 33518705
Fax 28435 0
Email 28435 0
rpssimoes@yahoo.com.br
Contact person for public queries
Name 11592 0
Dr Rodrigo Polaquini Simoes
Address 11592 0
Avenida Paulo VI
474 Jardim Cruzeiro do Sul.
Sao Carlos Sao Paulo CEP 13572-140
Country 11592 0
Brazil
Phone 11592 0
055 16 33752540
Fax 11592 0
055 16 33752540
Email 11592 0
rpssimoes@yahoo.com.br
Contact person for scientific queries
Name 2520 0
Dr Viviane Castello
Address 2520 0
Alderico Vieira Perdigao
125 CEP 13572-000
Jardim Cruzeiro do Sul
Sao Carlos Sao Paulo
Country 2520 0
Brazil
Phone 2520 0
055 16 91857776
Fax 2520 0
Email 2520 0
vivica_castello@yahoo.com.br

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5818 0
Sao Paulo Med J. 2009 May;127(2):78-83.
Attachments [1] 5818 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary